Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures

Bile Reflux Clinical Trial

Official title:

Prospective, Randomized, Controlled Trial of Omega Loop Gastric Bypass With and Without Anti-reflux Sutures - a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03097887
• Other study ID #: 1640/2016
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2020
• Source: Medical University of Vienna
• Contact: Daniel M Felsenreich, Dr.
• Phone: +43 1 40400
• Email: moritz.felsenreich[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Obesity, and especially its comorbidities, has unarguably become the number one threat to human health in the modern world. Western lifestyle leads to an increased prevalence and thus to a higher mortality (i.e. due to cardiovascular diseases).

The positive effects of gastric bypass surgery on excess weight loss and comorbidity resolution are well-known. In contrast to the standard laparoscopic Roux-en-Y Gastric Bypass (RYGB), a newer method, the laparoscopic Omega Loop Gastric Bypass (OLGB), has emerged over the past years. It is believed to be the simpler method involving only one anastomosis (instead of two) and therefore potentially reducing morbidity and mortality whilst maintaining comparable excess weight loss. However, since this new type of gastric bypass is similar to the former Billroth II resection (BII), the carcinoma risk is a concern. The OLGB is different from the BII resection in many ways. For instance, it involves creating an approximately 10 cm long narrow gastric pouch which could prevent the suspected underlying pathogenetic mechanism: biliary reflux to the gastric tube and subsequently to the esophagus. Biliary reflux is suspected to stimulate squamous esophageal cells and Barrett's epithelial cells to produce inflammatory mediators and therefore cause oxidative stress, DNA damage and apoptosis which might lead to adenocarcinoma.

Worldwide, there are currently two different ways to perform an OLGB: with or without anti-reflux sutures, which involve sewing the biliopancreatic limb to the staple line of the pouch using V-Loc (non-absorbable) moving upwards as far as easily possible without creating any tension.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age between 20 and 70 years

• Body Mass Index = 35.0 kg/m2

• Exclusion of psychological, endocrinological and anesthesiological contraindications

• Willingness to be assigned to either of the two groups

• Follow-up anticipation

• Willingness to attend all follow-up visits

• Written informed consent

Exclusion Criteria:

• 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.

Note: Exclusion can be performed by a study coordinator at any time.

Hiatal hernia is not considered an exclusion criterion in this study.

Related Conditions & MeSH terms

• Bile Reflux
• Gastroesophageal Reflux

Intervention

Procedure:
• Omega Loop Gastric Bypass
Bariatric/metabolic surgical procedure

Device:
• Bilitec 2000™
The Bilitec 2000™ device will be used to measure the intensity of biliary reflux in the pouch.
• V-Loc
Sewing device to perform the anti-reflux sutures.

Locations

Country	Name	City	State
Austria	Medical University Vienna	Wien	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Inflammation	Assessing inflammation before and 12 months after surgery using gastroscopy with biopsy.	1 year
Secondary	Weight loss	Measuring excess weight loss (EWL), to reveal any changes in patients' weight	1 year
Secondary	BMI loss	Excess BMI loss (EBMIL), to reveal any changes in patients' BMI	1 year
Secondary	Complications by point in time/stage	Early postoperative complications (occurring within 30 days) Late postoperative complications (occurring after 30 days)	1 year
Secondary	Complications by severity	Moderate complications (not requiring additional surgical intervention) Severe complications (requiring surgical intervention)	1 year
Secondary	Resolution of hyperlipidemia	Collecting evidence for the resolution of hyperlipidemia	1 year
Secondary	Resolution of hypertension	Collecting evidence for the resolution of hypertension	1 year
Secondary	Resolution of diabetes	Collecting evidence for the resolution of diabetes	1 year
Secondary	Resolution of sleep apnea	Collecting evidence for the resolution of sleep apnea	1 year