NCT03097887

Brief Summary

This proposed trial is designed to answer the following questions: First, is biliary reflux to the distal esophagus present before OLGB and does it increase after the procedure? Second, does performing an OLGB with or without anti-reflux sutures make a difference in (biliary) reflux exposures of the distal esophagus? To answer these questions the investigators plan to perform a randomized, controlled trial involving two groups. Group A will undergo an OLGB without anti-reflux sutures and consists of 50 patients. Group B will receive an OLGB with anti-reflux sutures and also consists of 50 patients. Gastroscopic evaluation for inflammation and reflux will be performed before and one year after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™. Furthermore, the study will be blinded to the patient. Long-term weight loss, the resolution of comorbidities and the incidence of surgical complications will serve as secondary endpoints. Follow-ups will be performed at 3, 6, and 12 months postoperatively to assess all primary and secondary goals.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
2.5 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

March 21, 2017

Last Update Submit

September 1, 2020

Conditions

Bile Reflux

Keywords

Omega Loop Gastric BypassRefluxMini Gastric Bypass

Outcome Measures

Primary Outcomes (2)

  • Bile Reflux

    The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Biliary exposure will therefore be assessed before and 12 months after the operation utilizing multilevel intraluminal impedance pH-monitoring (MII-pH) and intragastric Bilitec 2000™.

    1 year

  • Bile Reflux

    The primary goal of this study is to assess, whether the choice of method (OLGB with or without anti-reflux sutures) affects the occurrence or severity of biliary reflux to the gastric pouch. Extensive biopsies of the gastric pouch and gastroesophageal junction will be taken to prove histological changes due to biliary reflux.

    1 year

Secondary Outcomes (9)

  • Inflammation

    1 year

  • Weight loss

    1 year

  • BMI loss

    1 year

  • Complications by point in time/stage

    1 year

  • Complications by severity

    1 year

  • +4 more secondary outcomes

Study Arms (2)

Anti-reflux sutures

ACTIVE COMPARATOR

Omega Loop Gastric Bypass with anti-reflux sutures using V-Loc sewing device. Biliary reflux measured using Bilitec 2000™.

Procedure: Omega Loop Gastric BypassDevice: Bilitec 2000™Device: V-Loc

No anti-reflux sutures

ACTIVE COMPARATOR

Omega Loop Gastric Bypass without anti-reflux sutures. Biliary reflux measured using Bilitec 2000™.

Procedure: Omega Loop Gastric BypassDevice: Bilitec 2000™

Interventions

Omega Loop Gastric BypassPROCEDURE

Bariatric/metabolic surgical procedure

Also known as: Mini Gastric Bypass, Single Anastomosis Gastric Bypass
Anti-reflux suturesNo anti-reflux sutures
Bilitec 2000™DEVICE

The Bilitec 2000™ device will be used to measure the intensity of biliary reflux in the pouch.

Anti-reflux suturesNo anti-reflux sutures
V-LocDEVICE

Sewing device to perform the anti-reflux sutures.

Anti-reflux sutures

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20 and 70 years
  • Body Mass Index ≥ 35.0 kg/m2
  • Willingness to be assigned to either of the two groups
  • Follow-up anticipation
  • Willingness to attend all follow-up visits
  • Written informed consent

You may not qualify if:

  • recent or ongoing cardiovascular event within the last 6 months (myocardial infarction, acute coronary syndrome, angioplasty or coronary bypass operation, insult),
  • pulmonary embolism or thrombophlebitis within the last 6 months, other bariatric procedures, e.g. gastric banding, Sleeve Gastrectomy, etc., cancer of various origins (exceptions: basal cell carcinoma or carcinoma in situ, disease-free over the last 5 years),
  • significant anemia or coagulopathy,
  • serum creatinin ≥ 1.5 mg/dl.,
  • serum bilirubin or phosphatase elevated or ALT above 3 times the upper limit, stomach, biliopancreatic operations, splenectomy or colon resections, gastric or duodenal ulcer within the last 6 months,
  • intraabdominal sepsis (except uncomplicated appendicitis or diverticulitis over 6 months prior to the study),
  • organ transplantations,
  • anamnestic HIV infection, active TBC, active malaria, chronic Hepatitis B or C, liver cirrhosis,
  • alcohol or drug addiction (except caffeine, nicotine) in history,
  • acute psychiatric disease interfering with the proposed trial,
  • other chronic disease which might interfere with the participation.
  • Also, patients who are pregnant or plan a pregnancy within the following two years as well as patients who have been included in another study, will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Bile RefluxGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesDuodenogastric RefluxStomach DiseasesGastrointestinal DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal Diseases

Study Officials

  • Gerhard Prager, Univ. Prof.

    Vienna Medical University

    STUDY DIRECTOR

Central Study Contacts

Daniel M Felsenreich, Dr.

CONTACT

+43 1 40400moritz.felsenreich@meduniwien.ac.at

Gerhard Prager, Univ. Prof.

CONTACT

+43 1 40400gerhard.prager@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. univ.

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 31, 2017

Study Start

October 1, 2019

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

September 2, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Analysis will be performed on anonymized data only. A list cross-linking the patient number to the name will be kept secure and is only available to the principal researcher. Written informed consent will be kept for 15 years.

Locations

AU(1)