Determination of microbiological, macro and microscopic / histological characteristics after RYGB, mainly targeted at identifying inflammatory characteristics, bacterial (over) growth and / or atrophy / metaplasia in the excluded stomach and theā¦
ID
Source
Brief title
Condition
- Gastrointestinal disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determination of changes in macroscopic and histological characteristics of the
excluded stomach and blind loop after RYGB
Secondary outcome
N.A.
Background summary
The Roux-and-Y gastric bypass (RYGBP) changes the anatomy and function of the
gastrointestinal tract. A blind (Y-) loop (duodenum and proximal jejunum) is
created and a large part of the stomach diverted (excluded). This affects the
digestion and absorption of food in the intestine and causes histological
changes in the gastrointestinal tract. Histological examination of the blind
loop after RYGB has not been performed so far and histological changes in the
excluded stomach including the long-term consequences are insufficiently known.
Study objective
Determination of microbiological, macro and microscopic / histological
characteristics after RYGB, mainly targeted at identifying inflammatory
characteristics, bacterial (over) growth and / or atrophy / metaplasia in the
excluded stomach and the blind loop (duodenum and proximal jejunum).
Study design
Cross-sectional study.
The inflammatory, macro and microscopic histological characteristics are
described by endoscopic image and biopsy obtained via transgastric ERCP or
duodeno gastroscopy. Signs and severity of inflammation, atrophy and metaplasia
are described.
Study burden and risks
Biopsies of the excluded stomach and the blind loop are taken in patients who
have to undergo a laparoscopic assisted ERCP because of occluded choledochus
stones. The additional risks of participation in this study consist of possible
complications due to the biopsy (bleeding, perforations). The overall
percentage of complications in a normal oesophago-gastro-duodenoscopy (OGD)
(incl biopsy) is 0.009-0.13% with a mortality of 0.0009-0.004%, a perforation
risk of 0.0009% and a bleeding risk after biopsy of 0.002%. Participation in
this study thus gives a minimal additional risk on top of the already existing
risks of the endoscopy and laparoscopy.
There are no other additional surveys or visits required.
There is no benefit for the subject to be expected.
Louwesweg 6
Amsterdam 1066 EC
NL
Louwesweg 6
Amsterdam 1066 EC
NL
Listed location countries
Age
Inclusion criteria
Patients after Roux-en-y gastric bypass in need for endoscopic retrogate cholangio and pancreaticography.
Exclusion criteria
- Chronic gastrointestinal disease other than cholangitis
- No signed informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL62610.048.17 |