Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB (BiFLux)

• ClinicalTrials.gov Identifier: NCT04422405
• Recruitment Status: Recruiting
• First Posted: June 9, 2020
• Last Update Posted: October 22, 2020
• Sponsor: Spital Limmattal Schlieren
• Information provided by (Responsible Party): Marko Kraljevic, MD, Spital Limmattal Schlieren

Tracking Information

• First Submitted Date: May 25, 2020
• First Posted Date: June 9, 2020
• Last Update Posted Date: October 22, 2020
• Actual Study Start Date: June 1, 2020
• Estimated Primary Completion Date: May 28, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 4, 2020)

• Marginal ulcer rates [ Time Frame: 2 years post surgery ]
• Marginal ulcer rates [ Time Frame: 5 years post surgery ]
• Assessment of age as risk factor for marginal ulcer development [ Time Frame: 2 years post surgery ]
  Age of participants will be measured in years.
• Assessment of age as risk factor for marginal ulcer development [ Time Frame: 5 years post surgery ]
  Age of participants will be measured in years
• Assessment of gender as risk factor for marginal ulcer development [ Time Frame: 2 years post surgery ]
  The association between gender of participants (male/female) and incidence of marginal ulcers will be assessed.
• Assessment of gender as risk factor for marginal ulcer development [ Time Frame: 5 years post surgery ]
  The association between gender of participants (male/female) and incidende of marginal ulcers will be assessed.
• Assessment of tobacco use as risk factor for marginal ulcer development [ Time Frame: 2 years post surgery ]
  It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.
• Assessment of tobacco use as risk factor for marginal ulcer development [ Time Frame: 5 years post surgery ]
  It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.
• Assessment of alcohol use as risk factor for marginal ulcer development [ Time Frame: 2 years post surgery ]
  It will be assessed if the number of participants who report alcohol use correlates with the incidence of marginal ulcers.
• Assessment of alcohol use as risk factor for marginal ulcer development [ Time Frame: 5 years post surgery ]
  It will be assessed if the the number of participants who report alcohol use correlates with the incidence of marginal ulcers.
• Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development [ Time Frame: 2 years post surgery ]
  It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.
• Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development [ Time Frame: 5 years post surgery ]
  It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.
• Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development [ Time Frame: 2 years post surgery ]
  It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.
• Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development [ Time Frame: 5 years post surgery ]
  It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.
• Assessment of Helicobacter pylori as risk factor for marginal ulcer development [ Time Frame: 2 years post surgery ]
  It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcers.
• Assessment of Helicobacter pylori as risk factor for marginal ulcer development [ Time Frame: 5 years post surgery ]
  It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcer.
• Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development [ Time Frame: 2 years post surgery ]
  It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
• Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development [ Time Frame: 5 years post surgery ]
  It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
• Assessment of diabetes mellitus as risk factor for marginal ulcer development [ Time Frame: 2 years post surgery ]
  It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
• Assessment of diabetes mellitus as risk factor for marginal ulcer development [ Time Frame: 5 years post surgery ]
  It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
• Assessment of dyslipidemia as risk factor for marginal ulcer development [ Time Frame: 2 years post surgery ]
  It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.
• Assessment of dyslipidemia as risk factor for marginal ulcer development [ Time Frame: 5 years post surgery ]
  It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.
• Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development [ Time Frame: 2 years post surgery ]
  It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.
• Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development [ Time Frame: 5 years post surgery ]
  It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 4, 2020)

• Total weight loss % (TWL) [ Time Frame: 2 years post surgery ]
• Total weight loss % (TWL) [ Time Frame: 5 years post surgery ]
• Excess weight loss % (EWL) [ Time Frame: 2 years post surgery ]
• Excess weight loss % (EWL) [ Time Frame: 5 years post surgery ]
• Total BMI loss (TBL) [ Time Frame: 2 years post surgery ]
• Total BMI loss (TBL) [ Time Frame: 5 years post surgery ]
• Excess BMI loss (EBL) [ Time Frame: 2 years post surgery ]
• Excess BMI loss (EBL) [ Time Frame: 5 years post surgery ]
• Late morbidity (>30 days) [ Time Frame: 30 days post surgery ]
  Number of surgical complications according to Dindo-Clavien classification
• Late morbidity (>30 days) [ Time Frame: 5 years ]
  Number of surgical complications according to Dindo-Clavien classification
• Incidence of gastroesopagheal reflux disease (GERD) [ Time Frame: 2 years post surgery ]
  based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification
• Incidence of gastroesopagheal reflux disease (GERD) [ Time Frame: 5 years post surgery ]
  based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification
• Incidence of Barrett's esophagus [ Time Frame: 2 years post surgery ]
  based on biopsy findings
• Incidence of Barrett's esophagus [ Time Frame: 5 years post surgery ]
  based on biopsy findings
• Changes of esophageal motor function [ Time Frame: 2 years post surgery ]
  The esophageal motor function will be measured in mmHg via high-resolution manometry.
• Changes of esophageal motor function [ Time Frame: 5 years post surgery ]
  The esophageal motor function will be measured in mmHg via high-resolution manometry.
• Esophageal acid or bolus exposure [ Time Frame: 2 years post surgery ]
  Measured with impedance-pH Monitoring. Acid exposure (%) is defined as the total time the pH is < 4 divided by the time monitored. Bolus exposure (%) is defined as being analogous to acid exposure by adding the duration of all four reflux subcategories defined by the impedance, and dividing this value by the time monitored.
• Esophageal acid or bolus exposure [ Time Frame: 5 years post surgery ]
  Measured with impedance-pH Monitoring. Acid exposure (%) is defined as the total time the pH is < 4 divided by the time monitored. Bolus exposure (%) is defined as being analogous to acid exposure by adding the duration of all four reflux subcategories defined by the impedance, and dividing this value by the time monitored.
• Number of acid or alcaline reflux events [ Time Frame: 2 years post surgery ]
  Measured with impedance-pH Monitoring.
• Number of acid or alcaline reflux events [ Time Frame: 5 years post surgery ]
  Measured with impedance-pH Monitoring.
• Gastrointestinal quality of life (QoL): GIQLI [ Time Frame: 2 years post surgery ]
  The gastrointestinal (QoL) will be measured using the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a validated tool to assess health- related quality of life of patients with gastrointestinal disease or patients who undergo gastrointestinal operations. Its scale is 0-128. Higher values indicate a better quality of life outcome.
• Gastrointestinal quality of life (QoL): GIQLI [ Time Frame: 5 years post surgery ]
  The gastrointestinal (QoL) will be measured using the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a validated tool to assess health- related quality of life of patients with gastrointestinal disease or patients who undergo gastrointestinal operations. Its scale is 0-128. Higher values indicate a better quality of life outcome.
• Obesity- related quality of life (QoL): BAROS [ Time Frame: 2 years post surgery ]
  Obesity- related QoL will be measured with the BAROS (Bariatric Analysis and Reporting Outcome System). BAROS consists of a scoring table that includes three columns with the main areas of interest: weight loss, improvement of medical conditions, and QoL. A maximum of three points is given in each domain to evaluate changes after medical intervention (maximum score is 9 points). Higher scores indicate a better outcome.
• Obesity- related quality of life: BAROS [ Time Frame: 5 years post surgery ]
  Obesity- related QoL will be measured with the BAROS (Bariatric Analysis and Reporting Outcome System). BAROS consists of a scoring table that includes three columns with the main areas of interest: weight loss, improvement of medical conditions, and QoL. A maximum of three points is given in each domain to evaluate changes after medical intervention (maximum score is 9 points). Higher scores indicate a better outcome.
• Reflux-associated symptoms [ Time Frame: 2 years post surgery ]
  GERD symptoms will be measured with the Gastroesophageal reflux disease questionnaire (GERDQ). GERDQ has a scale between 0 and 18 points. Increasing scores correlate with increasing severity of heartburn symptoms.
• Reflux-associated symptoms [ Time Frame: 5 years post surgery ]
  GERD symptoms will be measured with the Gastroesophageal reflux disease questionnaire (GERDQ). GERDQ has a scale between 0 and 18 points. Increasing scores correlate with increasing severity of heartburn symptoms.
• Reflux-associated quality of life (QoL): GERD-HRQL [ Time Frame: 2 years post surgery ]
  Reflux- associated QoL will be assessed with the Health-related QoL scale for GERD (GERD-HRQL). The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition. Each item is scored from 0 to 5, with a higher score indicating a better QoL.
• Reflux-associated quality of life (QoL): GERD-HRQL [ Time Frame: 5 years post surgery ]
  Reflux- associated QoL will be assessed with the Health-related QoL scale for GERD (GERD-HRQL). The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition. Each item is scored from 0 to 5, with a higher score indicating a better QoL.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB
• Official Title: Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial
• Brief Summary: Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Obesity, Morbid
• GERD
• Ulcer, Gastric

Intervention

Procedure: One Anastomosis Gastric Bypass (OAGB)

The procedure is performed laparoscopically. The "GIA" stapler divides the stomach at the junction of the body and antrum. An Ewald tube, roughly the diameter of the esophagus, is passed by the anesthetist and held against the lesser curvature. The division of the stomach against the tube is completed, with 5- 6 lines of staples. The division of the stomach is parallel to the lesser curvature and up to the angle of His. A point is selected on the small bowel about 200 cm distal to the ligament of Treitz. The jejunal loop is brought up antecolic, and the Endo-GIA stapler is used to perform the anastomosis between the stomach and the small bowel at this point. The distal end of the gastric tube is anastomosed to the side of the small bowel.

Other Name: Mini-Gastric Bypass

Study Arms

Experimental: Patients undergoing OAGB

Intervention: Procedure: One Anastomosis Gastric Bypass (OAGB)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 4, 2020): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 28, 2028
• Estimated Primary Completion Date: May 28, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• BMI> 35 kg/m2
• 2 years of controlled conservative obesity treatment without weight reduction
• patients should give their consent to participate in the study

Exclusion Criteria:

• Less than 2 years of conservative obesity treatment
• cancer
• cirrhosis Child-Pough score A
• Crohn's disease
• serious psychiatric disorder, which led to in-hospital treatment in psychiatric clinic in the past two years
• drug consumption
• non-compliance
• hiatal hernia > 4cm
• gastric pouch < 10cm
• Barett esophagus
• erosive esophagitis Grade C or D according to the Los Angeles Classification
• endoscopically proven gastric stricture
• acid exposition time > 6% (Lyon criteria)
• reflux episodes> 80 /24 hours (Lyon criteria)
• insufficient low esophageal sphincter according to manometry findings
• pathological findings in the impedance pH-metry (acid and non-acid reflux)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Urs Zingg, MD, Prof.; +41 44 733 21 26; urs.zingg@spital-limmattal.ch

• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT04422405
• Other Study ID Numbers: SLS-003
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Marko Kraljevic, MD, Spital Limmattal Schlieren
• Original Responsible Party: Same as current
• Current Study Sponsor: Spital Limmattal Schlieren
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Spital Limmattal Schlieren
• Verification Date: October 2020