Medicolegal concerns in the management of - Dis Lair

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Choledocholithiasis
Introduction
Background
Symptomatic cholelithiasis is a common medical problem,
which makes cholecystectomy one of the most frequently
performed
surgical
procedures
in
the
world.
Choledocholithiasis
complicates
the
workup
and
management of cholelithiasis, necessitates additional
diagnostic and therapeutic procedures, and adds to the
morbidity and mortality of gallstone disease. Management of
choledocholithiasis has been the subject of much debate
over the past several years, especially with the advent of new
laparoscopic techniques and greater experience with
endoscopic procedures.
Pathophysiology
Choledocholithiasis occurs as a result of either the primary
formation of stones in the common bile duct (CBD) or the
passage of gallstones from the gallbladder through the cystic
duct into the CBD. (Examples of CBD stones are shown
below.) Bile stasis, bactibilia, chemical imbalances, pH
imbalances, increased bilirubin excretion, and the formation
of sludge are among the principal factors thought to lead to
the formation of these stones.
Gallstones are differentiated by their chemical composition.
Cholesterol stones are composed mainly of cholesterol, black
pigment stones are mainly pigment, and brown pigment
stones are made up of a mix of pigment and bile lipids.
Obstruction of the CBD by gallstones leads to symptoms and
complications
that
include
pain,
jaundice, cholangitis,pancreatitis, and sepsis.
Race
Differences in etiology and incidence are observed in persons
of different races. In the Asian population, infestation with A
lumbricoides and C sinensis is thought to promote bile stasis
and, hence, formation of primary CBD stones.
Sex
Cholelithiasis occurs more frequently in females than in
males.
Age
In the United States, the incidence rate for gallstones is
approximately 40% in individuals older than 60 years. In
individuals undergoing cholecystectomy for symptomatic
cholelithiasis, 8-15% of patients younger than 60 years have
CBD stones, compared to 15-60% of patients older than 60
years.
Clinical
History
Patients with choledocholithiasis may be completely
asymptomatic; in approximately 7% of cases, the stones are
found incidentally during cholecystectomy. Stones are seen
in 1% of autopsies performed on individuals older than 60
years who died of unrelated causes. Approximately 25-50%
of asymptomatic CBD stones eventually cause symptoms and
require treatment. Symptoms occur when the stones
obstruct the CBD. The clinical presentation varies depending
on the degree and level of obstruction and on the presence
or absence of biliary infection.
 A history of cholelithiasis is not essential for the
diagnosis of choledocholithiasis because gallbladder
stones can be asymptomatic.
 Pain is the most frequent presenting symptom. The pain
is colicky in nature, moderate in severity, and located in
the right upper quadrant of the abdomen. The pain is
intermittent, transient, and recurrent and may be
associated with nausea and vomiting. If the pain is
severe, consider a coexisting condition as the primary
cause of the pain.
 Jaundice occurs when the CBD becomes obstructed and
conjugated bilirubin enters the bloodstream. A history of
clay-colored stools and tea-colored urine is obtained
from such patients in approximately 50% of cases. The
jaundice can be episodic.
 Fever is an indication of cholangitis, and the classic
Charcot triad of fever, jaundice, and right upper
quadrant pain strongly favors the diagnosis. A study on
patients with cholangitis showed fever in 92% of
patients, jaundice in 65%, pain in 42%, and all 3 in 19%.
Cholangitis has a varied presentation, from a mild selflimiting illness to septic shock, observed in 5% of
patients.
 Gallstones are responsible for 50% of all cases of
pancreatitis. Conversely, 4-8% of patients with gallstones
develop pancreatitis. Pancreatitis can be precipitated if
CBD obstruction occurs at the level of the ampulla of
Vater. Pancreatic pain is different from biliary pain. The
pain is located in the epigastric and midabdominal areas
and is sharp, severe, continuous, and radiates to the
back. Nausea and vomiting are frequently present, and a
similar previous episode is reported by approximately
15% patients.
 A history of benign CBD strictures, sclerosing cholangitis,
sphincter of Oddi dysfunction, and cystic dilatation of the
CBD are important in the diagnosis of secondary biliary
stones.
 The presence of parasitic infestation with A
lumbricoides or C sinensis may result in the development
of primary CBD stones, observed in appropriate
populations
with
the
so-called
Oriental
cholangiohepatitis.
Physical
Specific findings upon physical examination are few and are
principally abdominal tenderness and jaundice.
 Tenderness is found in the right upper quadrant of the
abdomen. It is moderate in severity, and guarding
(voluntary or involuntary) or rebound is absent. Severe
tenderness, including the Murphy sign, should suggest
the presence of acute cholecystitis, either concomitantly
or alone.

The extent of icterus depends on the severity and
duration of CBD obstruction.
 Systemic signs such as fever, hypotension, and flushing
may be present and are often indicative of infection,
sepsis, or both.
Causes
CBD stones are either primary or secondary. Primary stones
arise within the biliary duct system, while secondary stones
develop in the gallbladder and migrate to the CBD. In the
United States, up to 85% of all CBD stones are secondary in
origin.
1. Primary CBD stones are caused by conditions leading to
bile stasis and chronic bactibilia. Up to 90% of patients
with brown pigment CBD stones have bile culture results
positive for bacteria. Primary duct stones are usually
brown pigment stones. Brown stones differ from black
pigment stones by having a higher content of
cholesterol. Brown stones are soft and earthy in
consistency and take the shape of the duct.
 In Western populations, biliary stasis is secondary to
factors such as sphincter of Oddi dysfunction, benign
biliary strictures, sclerosing cholangitis, and cystic
dilatation of the bile ducts. Bile stasis promotes growth
of bacteria, which produce phospholipase A1, thus
releasing fatty acids from biliary phospholipids. The duct
epithelium and/or bacteria (eg, Escherichia coli) produce
beta-glucuronidase in amounts sufficient to deconjugate
bilirubin diglucuronide. The presence of free fatty acids,
deconjugated bilirubin, and bile acids leads to the
formation of insoluble calcium bilirubinate particles.
With the loss of bile acids, cholesterol becomes
insoluble, resulting in the formation of biliary sludge. The
sludge also contains mucin and bacterial cytoskeletons,
which further aid in stone formation.
 In
Asian
populations,
infestation
with A
lumbricoides and C sinensis may promote stasis by either
blocking the biliary ducts or by damaging the duct walls,
resulting in stricture formation. Bactibilia is also common
in these instances, probably secondary to episodic portal
bacteremia. Some authors have suggested that the
stones are formed because of the bactibilia alone and
that the parasites' presence is just a coincidence.
2. Secondary CBD stones arise from the gallbladder,
migrate to the CBD, and have a typical spectrum of
cholesterol stones and black pigment stones. Bacteria
can be cultured from the surface of cholesterol and
pigment stones but not from the core, suggesting that
bacteria do not play a role in their formation.
 The prerequisites for the formation of cholesterol stones
are cholesterol supersaturation, stasis, and accelerated
nucleation. The sex of the patient, parity, obesity, weight
loss, and genetics are risk factors for the development of
cholesterol stones.

Black pigment stones typically occur in conditions in
which bilirubin excretion is increased, as in hemolytic
disorders and in situations associated with profound
gallbladder stasis such as prolonged fasting and longterm parenteral nutrition. Pigment stones are more
common in patients with cirrhosis and ileal disease,
although the exact mechanism of stone formation under
these conditions is not understood.
Differential Diagnoses
Abdominal Trauma, Blunt Cholecystitis
Ascariasis
Choledochal Cysts
Bile Duct Strictures
Cholelithiasis
Bile Duct Tumors
Gallbladder Cancer
Biliary Colic
Gallbladder Tumors
Biliary Obstruction
Hepatitis, Viral
Cholangiocarcinoma
Pancreatitis, Acute
Cholangitis
Ulcerative Colitis
Other Problems to Be Considered
Sclerosing cholangitis, Cholangiosarcoma
Workup
Laboratory Studies
1. Laboratory tests are helpful, but results are not specific
for the diagnosis of choledocholithiasis. As mentioned
earlier, patients with choledocholithiasis are often
asymptomatic, and, in such patients, laboratory test
results can be completely normal. Finding a laboratory
test that can help identify asymptomatic CBD stones and
thus reduce the need for invasive testing remains a
major diagnostic challenge.
2. Patients with cholangitis and pancreatitis have abnormal
laboratory test values. Importantly, a single abnormal
laboratory value does not confirm the diagnosis of
choledocholithiasis, cholangitis, or pancreatitis; rather, a
coherent set of laboratory studies leads to the correct
diagnosis.
 WBC count elevations indicate the presence of infection
or inflammation, but this finding is nonspecific.
 Serum bilirubin level elevations indicate obstruction of
the CBD; the higher the bilirubin level, the greater the
predictive value. CBD stones are present in
approximately 60% of patients with serum bilirubin
levels greater than 3 mg/dL.
 Serum amylase and lipase values are elevated in the
presence
of
acute
pancreatitis
complicating
choledocholithiasis.
 Alkaline
phosphatase
and
gamma-glutamyl
transpeptidase levels are elevated in patients with
obstructive choledocholithiasis. These test results have a
good predictive value for the presence of CBD stones.
 Prothrombin time may be elevated in patients with
prolonged CBD obstruction, secondary to depletion of
vitamin K (the absorption of which is bile-dependent).

Liver
transaminase
(serum
glutamic-pyruvic
transaminase
and
serum
glutamic-oxaloacetic
transaminase) levels are elevated in patients with
choledocholithiasis
complicated
by
cholangitis,
pancreatitis, or both.
 Blood culture results are positive in 30-60% of patients
with cholangitis.
Imaging Studies
1. Cholangiography remains the most reliable test for the
diagnosis of choledocholithiasis, but its invasive nature,
associated morbidity, and cost preclude it from being the
screening test of choice. Several diagnostic modalities
are available, and these are best divided into
preoperative, intraoperative, and postoperative studies.
The latter are used for the diagnosis of retained CBD
stones.
2. Preoperative studies
o Transabdominal ultrasonography
 This is a noninvasive, inexpensive, and readily available
modality for assessment of the biliary tree. It is usually
the first modality used in the diagnosis of patients with
biliary-related symptoms.
 Ultrasonography findings are accurate in the diagnosis of
gallbladder stones (97% in elective situations and 80% in
presence of acute cholecystitis), but CBD stones are
missed frequently (sensitivity 15-40%). The detection of
CBD stones is impeded by the presence of gas in the
duodenum, possible reflection and refraction of the
sound beam by curvature of the duct, and the location of
the duct beyond the optimal focal point of the
transducer.
 On the other hand, CBD dilatation is identified
accurately, with up to 90% accuracy.
 The usefulness of ultrasonography findings as a predictor
of CBD stones is at best 15-20%.
o Endoscopic ultrasonography
 This is the introduction of a high-frequency (7.5-12 MHz)
ultrasonic probe advanced into the duodenum under
endoscopic guidance. A water-filled balloon is used to
provide an acoustic window.
 Sensitivity and specificity of CBD stone detection are
reported in range of 85-100%. This is a significant
improvement over the transabdominal route.
 With endoscopic ultrasonography, the advantage of
noninvasiveness is lost, cost is increased, and the
services
of
an
experienced
endoscopist/ultrasonographer are needed.
o Computed tomography scan
 CT scan findings are very accurate in the detection of
biliary tree obstruction and ductal dilatation, both
intrahepatic and extrahepatic.
 CT scan has a sensitivity of 75-90% in the detection of
CBD stones, which makes it an essential tool in the
evaluation of patients with jaundice.

o

It is capable of defining the level of the obstruction and
provides information about the surrounding structures,
especially the pancreas.
Magnetic resonance cholangiopancreatography
This technique provides images, such as the one below,
derived from different magnetic properties of various
tissues. Gadolinium is used as a contrast for this test.

Magnetic resonance
cholangiopancreatogr
aphy
depicting
common bile duct and
common hepatic duct
full of stones.


o




It is a noninvasive tool with 97% accuracy, 92%
sensitivity, and 100% specificity. It is improving with the
advent of new sequences in imaging of the CBD.
Cost, inconvenience, and limitations (eg, obesity,
presence of metal objects, eg, pacemakers) are some of
its disadvantages.
Cholangiography
This remains the criterion standard for the detection of
CBD stones.
In the past, intravenous cholangiography was the only
available method for assessing the biliary tree, but the
results had poor accuracy and sensitivity, not to mention
major concerns with allergic reactions. Intravenous
cholangiography became obsolete with the introduction
of endoscopic retrograde cholangiopancreatography
(ERCP) and percutaneous transhepatic cholangiography
(PTC).
ERCP was introduced in the early 1970s and has become
the diagnostic and therapeutic tool of choice in patients
with choledocholithiasis. The CBD is cannulated through
the ampulla, contrast material is injected, and films are
obtained. The experience of the endoscopist is the best
predictor of success, which is 90-95% in expert hands.
Complications are hyperamylasemia and cholangitis.
Prophylactic antibiotics are often recommended,
especially in patients with CBD obstruction. In most
patients, ERCP is the modality of choice when
choledocholithiasis is suggested.1,2,3
PTC may be the modality of choice in patients in whom
ERCP is difficult (eg, those with previous gastric surgery
or distal obstructing CBD stone or the lack of an
experienced endoscopist) and in patients with extensive
intrahepatic stone disease and cholangiohepatitis. A long
large-bore needle is advanced percutaneously and
transhepatically into an intrahepatic duct, and
cholangiography is performed. A catheter can be placed
in the biliary tree over a guidewire. Uncorrected
coagulopathy is a contraindication for PTC, and the
normal size of the intrahepatic ducts makes the
procedure difficult. Prophylactic antibiotics are
recommended to reduce the risk of cholangitis.
3. Intraoperative studies4
 Intraoperative cholangiography
An area of much debate is the use of routine intraoperative
cholangiography (IOC) during a cholecystectomy. This debate
has lately gained momentum with the advent of the
laparoscopic cholecystectomy.5
The argument in favor of routine IOC is that it provides
accurate information about biliary anatomy and the presence
of CBD stones, thus decreasing the incidence of
intraoperative bile duct injury.
The counterpoint is that the incidence of retained CBD stones
is no greater in patients who underwent IOC only when CBD
stones were suggested clinically compared with patients in
whom it was performed routinely. Also, the risk of bile duct
injury is independent of whether an IOC was performed or
not. Other drawbacks include the risk and cost of the
procedure.
IOC is performed by inserting a catheter intraoperatively into
the cystic duct, followed by injection of diluted (50%)
contrast material to outline the biliary tree. Films are taken
and are assessed for the presence of filling defects, the
anatomy and caliber of the biliary tree, and the flow of
contrast into the duodenum. This procedure can be
performed at open or laparoscopic cholecystectomy.
IOC findings have a positive predictive value of 60-75% for
the detection of CBD stones. The procedure can fail due to
(1) inability to cannulate the cystic duct; (2) leakage of
contrast during the injection; (3) air bubbles mimicking
stones; (4) contrast flowing too quickly into the duodenum,
preventing proper filling of the biliary tree; and (5) spasm of
the sphincter of Oddi.
 Intraoperative ultrasonography
Special probes are used to visualize the biliary tree. It can be
performed using either open or laparoscopic techniques, and
results have a positive predictive value of approximately 75%.
The introduction of a small high-frequency probe in a 6F
sheath has made intraluminal ultrasonography possible.
The reported sensitivity is similar to that of IOC. Operator
dependency limits the usefulness of this modality.
4. Postoperative studies
T-tube cholangiography
 Retained CBD stones are identified in 2-10% of patients
after CBD exploration. These are most commonly
detected upon routine T-tube cholangiography
performed 7-10 days postoperatively.
 T-tubes are placed following CBD exploration to help in
the diagnosis and management of retained stones.
 If no obstruction is identified on the cholangiogram
findings, the tube is clamped and left in place for 6
weeks. The cholangiogram is repeated after 6 weeks
(small stones may pass spontaneously), and any retained
stones are removed percutaneously.
ERCP: After a cholecystectomy, ERCP is the modality of
choice to aid in the diagnosis and treatment of retained
stones that were undetected or were left behind to be dealt
with endoscopically.
PTC: This is used in patients with retained intrahepatic stones
or in patients with gastric surgery, in whom ERCP is more
difficult to perform.
Procedures
1. Choledochoscopy: Choledochoscopy can be performed
using either open or laparoscopic techniques. Small,
flexible choledochoscopes are introduced through an
open CBD or cystic duct. This enables direct visualization
and extraction of CBD stones. Sensitivity for detection
approaches 100% in expert hands. Choledochoscopy can
be performed postoperatively through the tract of a Ttube 6 weeks after the T-tube was placed.
2. Endoscopic sphincterotomy (EST): This procedure can be
performed preoperatively or postoperatively for CBD
stones. Usually, stones smaller than 1 cm pass
spontaneously within a few days of the sphincterotomy.
For extraction of larger stones, a basket or a balloon
catheter is required. EST is contraindicated in patients
with coagulopathy and usually in patients with a long
distal CBD.
3. In a study of 262 patients with choledocholithiasis who
underwent successful EST, Kageoka et al sought to assess
the long-term post-EST prognosis for these individuals
and to evaluate the need for cholecystectomy
subsequent to EST.6 The patients, whose follow-up
period lasted more than 6 months, were divided into the
following groups:
 Group A: Patients in whom cholecystectomy was
performed prior to EST; 18 patients
 Group B: Patients with a calculous gallbladder in whom
cholecystectomy was performed after EST; 129 patients
 Group C: Patients with a calculous gallbladder in situ; 46
patients
 Group D: Patients with an acalculous gallbladder in situ;
69 patients
4. The study's authors determined that late complications
occurred at a higher rate in group C (23.9%) than in
group B (7.8%) (P <0.001), although these complications
were not serious and could be managed surgically or
endoscopically. They also found that recurrent
choledocholithiasis occurred more frequently in group C
(17.4%) than in group B (7.8%) (P <0.05), with post-EST
pneumobilia being associated with these recurrences.
Eight of 115 patients with an intact gallbladder
developed acute cholecystitis, and 1 case of gallbladder
carcinoma was found after EST. Kageoka et al concluded
that EST is a safe and effective treatment for
choledocholithiasis
and
recommended
that
cholecystectomy be performed after EST in patients with
a calculous gallbladder.
Treatment
Medical Care
Several different modalities are available for the nonsurgical
treatment of choledocholithiasis. The choices include ERCP,
percutaneous extraction, and the remote consideration of
lithotripsy. The aim of treatment is to extract the stone;
however, if this is not possible, the aim is to provide drainage
for the obstructed bile in order to improve the patient's
condition while waiting for definitive surgical intervention.
These procedures can also be performed postoperatively to
remove retained stones.
1. Endoscopic retrograde cholangiopancreatography
 ERCP is used initially as a diagnostic procedure. Once the
presence of choledocholithiasis is confirmed (initial or
retained stones), therapeutic options depend on the size
and location of the stone(s).
 Small stones can be retrieved with a Dormia basket or a
Fogarty catheter with an intact papilla. In most
situations, a sphincterotomy is needed before the stones
can pass spontaneously or be extracted.
 Stones smaller than 1 cm pass spontaneously within 48
hours. Stones that are 1-2 cm in diameter require
extraction with the basket or Fogarty catheter in
addition to the sphincterotomy. Stones larger than 2 cm
in diameter usually require further treatment; lithotripsy
or chemical dissolution (cholesterol stones) with
monooctanoin acid via a nasobiliary tube has been
considered. If stone extraction is unsuccessful, a biliary
drainage procedure, whether internal or external, is
performed.
 The success rate of stone extraction by ERCP in cases of
choledocholithiasis is 85-90% in experienced hands.
Complications of sphincterotomy and stone extraction
occur in 10% of cases. These include bleeding (2%),
duodenal perforation (1%), cholangitis (2%), pancreatitis
(2%), bile duct injury (<1%), and the usual complications
associated with upper GI endoscopy (2%). The mortality
rate following EST is 1%. EST is contraindicated in
patients with uncorrected coagulopathy.
2. Percutaneous extraction
 This is performed after diagnostic PTC findings have
confirmed the presence of CBD stones. An external
biliary catheter is placed, and the tract is dilated over
several weeks (2-6 wk) up to 16F size by placement of
progressively larger catheters. The CBD stones are then
extracted using a Dormia basket or a choledochoscope.
Stones or their fragments can be trapped inside a basket
and passed through the sphincter of Oddi into the
duodenum. The procedure may need to be repeated for
complete clearance.
 The morbidity rate is approximately 10%, and the
mortality rate is 1%. Complications include bleeding,
duct injury, bile leakage, and cholangitis. The success
rate is 75-85%. The procedure is contraindicated in
patients with coagulopathy.
3. Extracorporeal shock wave lithotripsy
 This procedure has been mainly used as an adjunct to
sphincterotomy and a percutaneous approach.
 It carries a high rate of failure (95%) when used alone
and has a high complication rate (19%). Complications
include biliary pain (13%), cholangitis (5%), hemobilia
(5%), ileus (2.5%), and complications related to
procedure itself (13%).
Surgical Care
Surgical treatment may be required for CBD stones that are
discovered preoperatively or intraoperatively. Retained
stones in the CBD postoperatively are usually dealt with
endoscopically or by interventional radiology. If both
methods fail, operative management is contemplated. Two
issues must be addressed in the surgical treatment of
choledocholithiasis, as follows: (1) the exploration of the
CBD, and (2) the fate of the gallbladder. Exploration of the
CBD should include clearance of the stones and, sometimes,
a drainage procedure. Surgical methods used to achieve this
goal vary and can be performed by an open or laparoscopic
route. The timing and necessity of a cholecystectomy in
patients with choledocholithiasis who have asymptomatic
gallbladder stones remains a subject of debate.
1. Open choledochotomy
 Traditionally, open choledochotomy has been the
standard
of
care
for
the
treatment
of
choledocholithiasis. It remains a viable option in
situations in which laparoscopy is contraindicated or
when laparoscopy has failed. Although this procedure
carries a low morbidity and mortality rate in young
patients (<1%), the mortality rate is as high as 4% in
elderly populations. Moreover, it is associated with
greater postoperative pain and discomfort, and a more
prolonged recovery period is needed compared to the
laparoscopic or endoscopic methods.
 Choledochotomy is performed by placing 2 traction
sutures on either side of the intended choledochotomy
incision on the CBD distal to the cystic duct. The anterior
wall of the CBD is opened longitudinally for a distance of
approximately 1-1.5 cm, while traction is applied to the
sutures. Stone forceps, scoops, Fogarty balloon
catheters, and irrigating catheters can be used for the
removal of stones. A choledochoscope can be used for
confirming that the CBD is clear and for removing any
retained stones. A Dormia basket can be helpful at this
point.
 Once the CBD is cleared, it is closed over a 16F T-tube
using 4-0 monofilament absorbable suture. A closed
suction drain is placed in the foramen of Winslow in
anticipation of any bile leakage. A T-tube cholangiogram

2.







is performed 10-14 days postoperatively, and the T-tube
is removed if no retained stones are seen.
A small-caliber duct (<6 mm in diameter) is a relative
contraindication to choledochotomy.
Transcystic exploration
This technique is used to clear the CBD of stones during
laparoscopic cholecystectomy, after choledocholithiasis
is confirmed based on findings from IOC. The cystic duct
is dissected close to its junction with the CBD, and a
transverse incision is made in that area. A soft
hydrophilic guidewire is passed into the CBD through the
cholangiogram catheter under fluoroscopic guidance.
Once the position of the wire in the CBD is confirmed,
the cholangiogram catheter is advanced into the CBD.
Isotonic sodium chloride solution is used to irrigate the
CBD in an attempt to flush small stones through the
sphincter of Oddi or out through the opening in the
cystic duct. For extraction of larger stones, a Dormia
basket is passed over the guidewire into the CBD under
fluoroscopic guidance.
Throughout the procedure, constant flushing with
isotonic sodium chloride solution is performed. At the
end of the procedure, IOC is repeated to ensure that all
the stones have been removed.
If the cystic duct is large enough or can be balloondilated, a flexible choledochoscope can be passed and
the CBD examined under direct vision. The CBD is kept
inflated with isotonic sodium chloride solution for better
visualization. Intraluminal stones can be extracted with a
basket under direct vision using the working port of the
scope.
In the case of large impacted stones (>8 mm),
intracorporeal lithotripsy can be used. This procedure
employs either pulse-dye laser or electrohydraulic pulses
that cause fragmentation of the stone. The smaller
fragments are treated as described in Medical Care.
Clear visualization of the stone is required in order to
avoid misdirecting the energy of the probe and causing
CBD injury. Due to the high cost and the fact that most
CBD stones can be managed successfully without the use
of intracorporeal lithotripsy, few centers have gained
sufficient experience with this technique.
Balloon dilatation of the sphincter of Oddi can be
performed when all other techniques have failed to clear
the stones. A risk exists for mild pancreatitis (3% in one
series). This procedure should be avoided in patients
with a diagnosis of biliary dyskinesia, pancreatitis, and
sphincter anomalies. It is indicated in the presence of
small ducts, for which the risk of CBD stricture after
choledochotomy is high. In one small series of 20
patients, the success rate was 80%.
Antegrade sphincterotomy can be performed; the
morbidity rate is low and the success rate is 100%, as
3.


reported in a series of 22 patients. The success rate for
the transcystic approach is 80-95%.
Drainage procedures (transduodenal sphincteroplasty
choledochoduodenostomy, choledochojejunostomy)
Transduodenal sphincteroplasty entails a retrograde
approach to the exploration and clearance of the CBD.
o During open surgery and after cholecystectomy
has been completed, a Fogarty balloon catheter
is passed through the cystic duct into the CBD
and through the sphincter of Oddi. The
duodenum is then mobilized by performing the
Kocher maneuver. The ampulla is identified by
palpating the balloon catheter, and a small
transverse duodenotomy is performed on the
anterior duodenal wall just above the ampulla.
o A sphincterotomy is performed at the 11-o'clock
mark (to avoid the pancreatic duct, which is
located between the 4- and 5-o'clock positions).
The sphincterotomy is carried for a distance of
approximately 1 cm. The edges of the incision
are sutured at the beginning of the incision and
at its apex using an absorbable suture. The
balloon catheter is withdrawn from the cystic
duct and inserted through the ampulla in a
retrograde fashion to extract the stones. A
choledochoscope can also be used.
o After the duodenotomy is closed in a transverse
fashion, a completion cholangiogram is
performed through the cystic duct. The cystic
duct stump is closed.
o The advantages of this procedure are that (1) it
avoids a choledochotomy, (2) it is good for
small-caliber CBDs, and (3) it facilitates
drainage. The drawbacks are that it requires
open surgery and opening of the duodenum.
The success rate in an earlier series was
reported as 90-100%, with morbidity and
mortality rates slightly better than that with
open choledochotomy. No biliary strictures
were reported.
o Approximately 30% of all patients requiring an
open choledochotomy need a drainage
procedure. Indications for a drainage procedure
are multiple CBD stones (>4), sphincter of Oddi
stenosis or dysfunction, primary CBD stones,
previous choledocholithotomy, and marked CBD
dilatation.
Choledochoduodenostomy is the most commonly
employed drainage procedure and can be performed
either side-to-side or end-to-side. In the side-to-side
procedure, sump syndrome is a feared complication, in
which food particles reflux into the CBD, resulting in
obstruction, cholangitis, and/or pancreatitis. This
complication can be diminished if the size of the
anastomosis is limited to 14 mm.
 Choledochojejunostomy is performed either in
continuity or preferably as a Roux-en-Y loop that is
passed in a retrocolic fashion. The preferred anastomotic
size is 2.5 cm. It has the disadvantage of an added
anastomotic line, but an advantage is that it is not
associated with reflux of food particles.
4. Cholecystectomy
 Performance of a cholecystectomy in patients with
choledocholithiasis remains controversial, although most
experts recommend it. However, in patients who cannot
tolerate surgery well (eg, due to age, medical problems),
leaving the gallbladder in situ is an option as long as the
organ is asymptomatic.
 Cholecystectomy is not indicated for primary CBD
stones.
Consultations
Management of choledocholithiasis is a multidisciplinary
affair and requires the expertise of various medical
specialists.
 Obviously, the gastroenterologist/endoscopist and the
general/laparoscopic surgeon are the key players.
 An interventional radiologist is needed for both diagnosis
and treatment at times, and the services of an infectious
disease specialist are required in patients with
cholangitis.
 In case lithotripsy is considered, the services of a
clinician with experience in this rarely performed
procedure are necessary.
Diet
Patients with choledocholithiasis are instructed to not take
anything by mouth on the day of the procedures. No special
diet is required either before or after the procedure.
Medication
Medications are used as an adjunct in the management of
choledocholithiasis. See In/Out Patient Meds.
Antibiotics
Need for prophylaxis and therapy depends on the patient's
clinical presentation.
Piperacillin (Pipracil)
Inhibits biosynthesis of cell wall mucopeptides and is
effective during the stage of active multiplication. Has
antipseudomonal activity.
Adult: 2-3 g/dose IV/IM q6-12h; not to exceed 2 g with IM
injection
Serious infection: 3-4 g/dose IV/IM q4-6h; not to exceed 24
g/d
Pediatric: 200-300 mg/kg/d IV/IM divided q4-6h
Piperacillin and tazobactam (Zosyn)
Antipseudomonal penicillin plus beta-lactamase inhibitor.
Inhibits biosynthesis of cell wall mucopeptide and is effective
during the stage of active multiplication.
Adult: 3/0.375 g (piperacillin 3 g and tazobactam 0.375 g) IV
q6h
Pediatric: 75 mg/kg of piperacillin component IV q6h
Mezlocillin (Mezlin)
Interferes with bacterial cell wall synthesis during the growth
phase. Has antipseudomonal activity.
Adult: 3-4 g IV/IM q4-6h
Pediatric: 300 mg/kg/d IV/IM divided q4-6h; not to exceed 24
g/d
Ceftriaxone (Rocephin)
Third-generation cephalosporin with broad-spectrum gramnegative activity; lower efficacy against gram-positive
organisms; higher efficacy against resistant organisms.
Arrests bacterial growth by binding to one or more penicillinbinding proteins.
Adult: Uncomplicated infections: 250 mg IM once; not to
exceed
4
g
Severe infections: 1-2 g IV qd or divided bid; not to exceed 4
g/d
Pediatric: >7 d: 25-50 mg/kg/d IV/IM; not to exceed 125
mg/d
Infants and children: 50-75 mg/kg/d IV/IM divided q12h; not
to exceed 2 g/d
Ampicillin and sulbactam (Unasyn)
Drug combination of beta-lactamase inhibitor with ampicillin.
Covers skin, enteric flora, and anaerobes. Not ideal for
nosocomial pathogens.
Adult: 1.5 (1 g ampicillin + 0.5 g sulbactam) to 3 g (2 g
ampicillin + 1 g sulbactam) IV/IM q 6-8h; not to exceed 4 g/d
sulbactam or 8 g/d ampicillin
Pediatric: <3 months: Not established
3 months to 12 years: 100-200 mg/kg/d ampicillin (150-300
mg Unasyn) IV divided q6h
>12 years: Administer as in adults; not to exceed 4 g/d
sulbactam or 8 g/d ampicillin
Gentamicin (Garamycin, Gentacidin)
Aminoglycoside antibiotic for gram-negative coverage. Used
in combination with both an agent against gram-positive
organisms and one that covers anaerobes. Not the DOC.
Consider if penicillins or other less toxic drugs are
contraindicated, when clinically indicated, and in mixed
infections caused by susceptible staphylococci and gramnegative organisms. Dosing regimens are numerous; adjust
dose based on CrCl and changes in volume of distribution.
May be given IV/IM.
Adult: Serious infections and normal renal function: 3
mg/kg/d
IV
q8h
Loading
dose:
1-2.5
mg/kg
IV
Maintenance
dose:
1-1.5
mg/kg
IV
q8h
Extended dosing regimen for life-threatening infections: 5
mg/kg/d
IV/IM
q6-8h
Follow each regimen by at least a trough level drawn on the
third or fourth dose (0.5 h before dosing); may draw a peak
level 0.5 h after 30-min infusion
Pediatric: <5 years: 2.5 mg/kg/dose IV/IM q8h
>5 years: 1.5-2.5 mg/kg/dose IV/IM q8h or 6-7.5 mg/kg/d
divided q8h; not to exceed 300 mg/d; monitor as in adults
Metronidazole (Flagyl)
Imidazole ring-based antibiotic active against various
anaerobic bacteria and protozoa. Used in combination with
other antimicrobial agents (except for Clostridium
difficile enterocolitis).
Adult: Loading dose: 15 mg/kg, or 1 g for 70-kg adult, IV over
1h
Maintenance dose: 6 h following loading dose; infuse 7.5
mg/kg, or 500 mg for 70-kg adult, IV over 1 h q6-8h; not to
exceed 4 g/d
Pediatric: Administer as in adults
Gastrointestinal agents
Used for stress ulcer prophylaxis.
Sucralfate (Carafate)
Forms a viscous adhesive substance that protects the GI
lining against pepsin, acid, and bile salts. Use for short-term
management of ulcers.
Adult: 1 g PO qid
Pediatri: Not established; 40-80 mg/kg/d PO divided q6h
suggested
Histamine-2 receptor antagonists
Reversible competitive blockers of H2 receptors, particularly
those in the gastric parietal cells, where they inhibit acid
secretion. H2 antagonists are highly selective, do not affect
H1 receptors, and are not anticholinergic agents.
Ranitidine (Zantac)
Inhibits histamine stimulation of the H2 receptor in gastric
parietal cells, which, in turn, reduces gastric acid secretion,
gastric volume, and hydrogen ion concentrations.
Adult: 150 mg PO bid; not to exceed 600 mg/d; alternatively,
50 mg/dose IV/IM q6-8h
Pediatric:
<12
years:
Not
established
>12 years: 1.25-2.5 mg/kg/dose PO q12h; not to exceed 300
mg/d; 0.75-1.5 mg/kg/dose IV/IM q6-8h; not to exceed 400
mg/d
Famotidine (Pepcid)
Inhibits histamine stimulation of the H2 receptor in gastric
parietal cells, which, in turn, reduces gastric acid secretion,
gastric volume, and hydrogen ion concentrations.
Adult: 40 mg/d PO bid for 4-8 wk; 20 mg IV bid
Pediatric: Not established; 1-2 mg/kg/d IV/PO divided q6h;
not to exceed 40 mg/dose, suggested
Anticoagulants
Used for DVT prophylaxis.
Heparin
Augments activity of antithrombin III and prevents
conversion of fibrinogen to fibrin. Does not actively lyse but
is able to inhibit further thrombogenesis. Prevents
reaccumulation of clot after spontaneous fibrinolysis.
Adult: Treatment: 60 U/kg IV bolus (not to exceed 4000 U),
followed by 12 U/kg/h maintenance infusion (not to exceed
1000
U/h)
Prophylaxis: 5000 U SC q12h
Pediatric: Not established
Enoxaparin (Lovenox)
Prevents DVT, which may lead to pulmonary embolism in
patients undergoing surgery who are at risk for
thromboembolic complications. Enhances inhibition of factor
Xa and thrombin by increasing antithrombin III activity. In
addition, preferentially increases inhibition of factor Xa.
Average duration of treatment is 7-14 d.
Adult: DVT prophylaxis: 30 mg SC q12h
Treatment: 1 mg/kg/dose SC q12h
Pediatric: Not established; suggested dose is described below
<2 months: 0.75 mg/kg/dose SC bid
>2 months: 0.5 mg/kg/dose SC bid
Proton pump inhibitors
Indicated for peptic ulcer disease. Indicated for prophylaxis
against stress ulcerations in setting of choledocholithiasis.
Should be reserved for patients with known peptic ulcer
disease.
Omeprazole (Prilosec)
Description Decreases gastric acid secretion by inhibiting
parietal cell H+/K+ -ATP pump.
Adult: 20 mg PO qd for 4-8 wk
Pediatric: Not established
Follow-up
Further Inpatient Care
Tube cholangiography: Whenever a tube or biliary drain is
placed (eg, surgically, percutaneously, or radiologically), a
follow-up cholangiogram through the tube is recommended.
A tube cholangiogram helps assess for the presence of
retained stones, the status of the sphincter of Oddi, the
architecture of the biliary tree, and the condition of the
anastomosis. This study is best performed under fluoroscopic
guidance in the radiology department.
Laboratory data: Serum bilirubin levels and liver enzymes are
measured in the postprocedure period as part of follow-up
care.
Further Outpatient Care
Laboratory data: Serum bilirubin levels and liver enzymes are
measured in the postprocedure period as follow-up care.
Management of retained stones: Extraction (or consideration
of lithotripsy) of retained stones is performed 6 weeks after
placement of a biliary drain or catheter, when the tract is
mature. Dissolution of the stones using monooctanoin is
another option.
Inpatient & Outpatient Medications
1. Antibiotics
 Antibiotics are needed for prophylaxis or for acute
infection, depending on the patient's presentation. In
the absence of biliary infection and in the setting of a
procedure that results in manipulation of the biliary tree,
antibiotic prophylaxis may be indicated. Single-drug
therapy with a broad-spectrum antibiotic is preferable.
The newer penicillins (piperacillin, mezlocillin), with or
without beta-lactamase inhibitor, are effective because
of their broad coverage. This is also true of some of the
third-generation cephalosporins.
 Administer the antibiotics intravenously immediately
before the procedure and discontinue them at the end
of the procedure, unless a prosthesis or a drain is
inserted. In the setting of cholangitis, antibiotics are used
therapeutically. Traditionally, ampicillin was used in
combination with an aminoglycoside and metronidazole
as a broad-spectrum regimen for empirical treatment
until specific culture and sensitivity results were
obtained. However, as mentioned above, the broadspectrum newer penicillins or third-generation
cephalosporins, with or without beta-lactamase
inhibitors, are good choices. Antibiotics are customized
after obtaining culture results. In mild cases, antibiotics
can be administered at home either orally or
intravenously.
2. Stress ulcer prophylaxis: This is achieved by using
sucralfate, H2 antagonists, or proton pump inhibitors.
3. Deep venous thrombosis prophylaxis: A mini dose of
heparin (5000 U SC q12h) or low molecular weight
heparin can be used in conjunction with sequential
compression pneumatic stockings. Early ambulation
remains the best preventative approach.
Transfer
The patient should be transferred to a center capable of
handling this problem. Specialists in the fields mentioned
inConsultations should be available, and the center should be
equipped with the diagnostic and therapeutic modalities
necessary for the job at hand.
Complications
 Cholangitis
 Gallstone pancreatitis
 Liver failure and cirrhosis
 Sepsis
 Renal failure
 Respiratory insufficiency
 Retained and impacted stones
 Biliary duct injury
 Hepatic vascular injury
Prognosis
Prognosis of choledocholithiasis depends on the presence
and severity of complications. Of all patients who refuse
surgery or are unfit to undergo surgery, 45% remain
asymptomatic from choledocholithiasis, while 55%
experience varying degrees of complications.
Patient Education
For excellent patient education resources, visit
eMedicine's Liver,
Gallbladder,
and
Pancreas
Center andCholesterol Center. Also, see eMedicine's patient
education article Gallstones.
Miscellaneous
Medicolegal Pitfalls
Medicolegal
concerns
in
the
management
of
choledocholithiasis are multifaceted. They relate to the
diagnosis, management, and follow-up because of the
complexity of the issue. Maintaining the standard of care and
obtaining the appropriate consultations help mitigate
medicolegal concerns.
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