Supplementary Table 4: Periprocedure and postoprocedure complications with Endobarrier devices across different studies
S.No
Author/
Year/
Location
Device/Int
ervention
Number of
subjects
Technique
Duration of
intervention
Peri-procedure
complication
Minor adverse events (self
limited/ mild -moderate)
(procedure related)
Major adverse events
(severe)(procedure related)
1
Gersinn et al.
2007
U.S.A
[5]
Duodenojej
unal bypass
sleeve
(DJBS)
1
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
12 weeks
None
None
None
2
RodriguezGrunert et
al.
2007
U.S.A.
[6]
12 weeks
Two (during
explantation, no
intervention
required)a.) Oropharyngeal
mucosal tear- 1/2
b.) Esophageal
mucosal tear- 1/2
1. Abdominal pain- 6
2. Nausea- 18
3. Vomiting- 16
4. Diarrhoea- 1
5. Implant site
inflammation- 12
Abdominal pain- 2- requiring early
explantation of device (9 days
after implant) (attributed to poor
device placement)
1. Nausea- 10/21
2. Vomiting- 6/21
1. Upper abdominal pain14
2. Nausea- 6
3. Vomiting- 4
4. Constipation- 3
5. Dyspepsia- 2
6. Pyrexia- 2
7. Abdominal Pain- 2
1. Early device explantation (7/21)1.) Hematemesis- 3/21 at 11, 25
and 43 days post implant
2.) Abdominal pain/
nausea/vomiting- 4/21 at 3, 9, 30
and 36 days post implant
None
Not applicable (N/A)
N/A
3
DJBS
implant
12
DJBS
implant
Enrolled- 25
Successfully
underwent
implantation
- 21
Gersin et al.
2009,
U.S.A
[7]
Fluoroscope and Endoscope
was used to deliver the
DJBS implant over the wire
catheter system
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
12 weeks
Esophagog
astroduode
noscopy
(EGD) and
mock
implantatio
n
26
Endoscopy
S.No
4
5
Author/
Year/
Location
Sandler et al.
2010,
U.S.A
[8]
Rodrigruez
et al.
2009,
Chile
[9]
Device/Int
ervention
Gastroduod
enojejunal
Bypass
Sleeve
(GDJBS)
Number of
subjects
Enrolled- 24
Successfully
implanted22
Technique
Endoscopically delivered
with laparoscopic assistance
DJBS
implant
12
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
EGD
without
implant
6
Endoscopy
Duration of
intervention
12 weeks
Minor adverse events (self
limited/ mild -moderate)
(procedure related)
Major adverse events
(severe)(procedure related)
None
None
1. Pain with swallowing- 5/22, all 5
subjects underwent early
explantation
2. Difficulty with transition to
pureed diet- found to have kink
within the stomach, endoscopy to
correct the kink, no device
explantation required.
1. Early device explantation(4/12)a.) Device migration/rotationi.) Symptomatic- 3/4
ii.) Asymtpomatic- 1/4 (discovered
on scheduled endoscopy)
N/A
Peri-procedure
complication
200 + 22
days
1. Nausea- 3/12
2. Vomiting- 2/12
1. Upper abdominal pain20
2. Nausea- 5
3. Vomiting- 7
4. Constipation- 1
5. Hypoglycemic symptoms5
6. Flatulence- 3
7. Abdominal Pain- 3
8. Diarrhoea- 1
9. Erosive duodenitis- 2
10. Gastritis- 1
11. Esophagitis- 1
190 + 44
days
Data not available
(DNA)
N/A
2
Author/
Year/
Location
Device/Int
ervention
Number of
subjects
Technique
Duration of
intervention
Peri-procedure
complication
Minor adverse events (self
limited/ mild -moderate)
(procedure related)
6
Escalona et
al.
2009,
Chile
[10]
Flow
restrictor
DJBL
implant
(DJBL with
a
fluoropoly
mer
proximal
plate with 4
mm orifice)
Enrolled,
who
met study
criteria- 10
DJBS implant was delivered
with help of endoscope and
fluoroscopy; 7/10 subjects
required orifice dilatation
(1/10- two times, 6/10- one
time)
12 weeks
1. Nausea- 4/11
(36%) (ITT analysis)
2. Vomiting- 3/11
(27%)
1. Abdominal Pain- 7/11 (64%) (ITT analysis)
2. Nausea- 2/11 (18%)
3. Vomiting- 5/11 (46%)
All of above symptoms improved with orifice dilation
7
Escalona et
al.
2012,
Chile
[11]
None
1. Upper abdominal pain81%
2. Nausea- 41%
3. Vomiting- 33%
4. Gastroenteritis- 4.8%
S.No
DJBS
implant
Enrolled- 42
Successfully
implanted39
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
52 week
3
Major adverse events
(severe)(procedure related)
1. Early device
explantation(15/39)a.) Device migration/movement8/15
b.) Device obstruction- 3/15
c.) Abdominal pain- 2/15
d.) Acute cholecystitis- 1/15
e.) Patient request- 1/15
S.No
8
Author/
Year/
Location
Munoz et al.
2013,
Chile
[12]
Device/Int
ervention
DJBS
implant
Number of
subjects
79
Technique
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
Duration of
intervention
1 year
4
Peri-procedure
complication
DNA
Minor adverse events (self
limited/ mild -moderate)
(procedure related)
Major adverse events
(severe)(procedure related)
DNA
1. Early device explantation- 18/79
a.) Migration- 8/18
b.) Obstruction- 5/18
c.) Abdominal pain- 2/18
d.) Liver abscess- 1/18
e.) Upper GI bleed- 1/18
f.) Cholangitis- 1/18
g.) Ulcerative colitis- 1/18
h.) Acute cholecystitis- 1/18
i.) Patient request- 1/18
S.No
9
10
Author/
Year/
Location
Schouton et
al.
2010,
Netherlands
[13]
Koehestanie
et al.
2013,
Netherlands
[14]
Device/Int
ervention
Number of
subjects
Technique
DJBS
implant +
low calorie
diet
Enrolled- 30
Succesfully
implanted26
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
Low calorie
diet only
11
N/A
DJBS
implant
28
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
Duration of
intervention
Minor adverse events (self
limited/ mild -moderate)
(procedure related)
Major adverse events
(severe)(procedure related)
None
1. Nausea- 20
2. Upper abdominal pain13
3. Pseudopolyp- 13
4. Implant site
inflammation- 10
5. Vomiting- 6
1. Early device explantation(4/26)a.) Device migration/rotationi.) Symptomatic- 1/4 (3m post
implant)
ii.) Asymtpomatic- 1/4 (discovered
on scheduled endoscopy, 4 m post
implant)
b.) Epigastric pain- 1/4 (3m post
implant)
c.) Nausea and vomiting- 1/4
(sleeve obstruction, 1 wk post
implant)
N/A
N/A
N/A
None
DNA
None
Peri-procedure
complication
24 weeks
1 year
5
S.No
Author/
Year/
Location
Device/Int
ervention
Number of
subjects
Technique
Duration of
intervention
Peri-procedure
complication
Minor adverse events (self
limited/ mild -moderate)
(procedure related)
Major adverse events
(severe)(procedure related)
DJBS
implant
28
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
1 year
None
DNA
None
24 weeks
DNA
DNA
DNA
6 months
DNA
DNA
DNA
11
De Jonge et
al.
2013,
Netherlands
[15]
DJBS
implant
17
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
12
De Moura et
al.
2011,
Brazil
[16]
DJBS
implant
Enrolled- 81
Successfully
implanted78
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
6
S.No
13
Author/
Year/
Location
De Moura et
al,
2011,
Brazil
[17]
Device/Int
ervention
DJBS
implant
Number of
subjects
22
Technique
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
Duration of
intervention
52 week
7
Peri-procedure
complication
1. Nausea- 10/22
(45.5%)
2. Vomiting- 7/22
(31.8%)
Minor adverse events (self
limited/ mild -moderate)
(procedure related)
Major adverse events
(severe)(procedure related)
1. GI complaints- 21/22
(95.5%)
a.) Abdominal distention3/22 (13.6%)
b.) Abdominal pain upper20/22 (90.9%)
c.) Diarrhea- 3/22 (13.6%)
d.) Nausea- 11/22 (50%)
e.) Vomiting- 14/22 (63.6%)
1. Early device explantation (9/22)a.) Device migration/rotation- 3/9
at 36,36 and 48 wks post implant
b.) GI bleeding- 1/9 at 4 weeks
post implant
c.) Abdominal pain- 2/9 at 21 and
30 wk post implant
d.) Subject non compliance with
follow up- 2/9 at 20 and 32 wks
post implant
e.) Metastatic ovarian cancer- 1/9
unrelated to device, 17 weeks post
implant.
S.No
14
Author/
Year/
Location
Tarnoff et al.
2008
U.S.A, Chile,
Brazil
[18]
Device/Int
ervention
Number of
subjects
Technique
Duration of
intervention
Peri-procedure
complication
Minor adverse events (self
limited/ mild -moderate)
(procedure related)
DJBS
implant
and low fat
diet
Enrolled- 26
Successfully
implanted25
DJBS implant was delivered
with help of endoscope and
fluoroscopy using wire
catheter system
12 wks
Noncardiac chest
pain- 1/25
1. GI tract Hemorrhage1/25
2. Nausea- 6/25
3. Abdominal pain- 15/25
4. Vomiting- 8/25
5. Abdominal distention11/25
6. Constipation- 1/25
7. Epigastric discomfort1/25
Low fat diet
alone
14
N/A
12 wks
N/A
N/A
Abbreviations:
DJBS- Duodenojejunal bypass sleeve
DNA- Data not available
EGD- Esophagogastroduodenoscopy
GDJBS- Gastroduodenojejunal bypass sleeve
GI- Gastrointestinal
N/A- Not applicable
8
Major adverse events
(severe)(procedure related)
1. GI tract Hemorrhage- 3/25
2. Nausea- 1/25
3. Abdominal pain- 1/25
5/25 subjects underwent early
device explantation- 1. GI bleed at
12-17 day-3/5
2. Sleeve obstruction at 30th day1/5
3. Device migration at 47th day1/5
N/A