Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation (SG-4MOST)

Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation: A Randomized Controlled Trial Comparing Sleeve Gastrectomy Following Liver Transplantation to No Surgical Intervention in Patients With Morbid Obesity

Complications associated with excess weight (hypertension, coronary artery disease and diabetes) have become major causes of morbidity and mortality after liver transplantation (LT). To ensure excellent long-term outcomes with LT it is critically important to understand the best strategies to minimize obesity and its associated complications in our patients. Weight loss can be achieved through dieting and exercise, but most patients are unable to maintain the weight loss. In the general population, bariatric surgery is much more effective than medical treatment for permanent weight loss and prevention or reduction of obesity-associated complications.

The purpose of this study is to determine the safety and effectiveness of performing sleeve gastrectomy (SG) procedure in the early post-LT period in obese patients.

The patient population for this study will be anyone listed for liver transplantation at Toronto General Hospital (University Health Network, Toronto, ON, Canada) and meeting the current standard criteria for bariatric surgery (BMI>40, or BMI>35 with at least 1 obesity-related complication).This study will randomly assign eligible participants to one of two groups (1:1). Patients in group 1 will receive standard lifestyle/diet counselling while patients in group 2 will undergo SG-specific counselling prior to transplant and the SG procedure within 2 weeks of LT (if safe to do so).

All participants will be followed for 12 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplantation; Obesity
• Intervention / Treatment: Procedure: Sleeve gastrectomy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin Winter, BSc; Phone Number: 6093 416-340-4800; Email: erin.winter@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• actively listed for liver transplantation at University Health Network
• BMI at screening of a) >40; or b) BMI >35 and 1 obesity-related complication [diabetes (defined as hyperglycemia requiring medication(s) for control), hypertension (defined as a persistently elevated systolic pressure greater than 140 mmHg and/or requiring medication(s) for control), hypercholesterolemia (defined as elevated lipids requiring medication for control)] OR a diagnosis of Non Alcoholic Fatty Liver Disease (defined as the presence of a fatty liver on imaging without a secondary cause such as alcohol abuse) or Non Alcoholic Steatohepatitis
• upper endoscopy showing no contraindications to a sleeve gastrectomy procedure

Exclusion Criteria:

• • Listed for re-transplantation, or transplantation of another organ (eg. kidney).

  • Previous bariatric surgery.
  • Contraindication to undergoing sleeve gastrectomy such as severe gastroesophageal reflux disease or Barrett's Esophagus
  • MELD (Model End-Stage Liver Disease) score > 35 at the time of transplantation
  • Presence of any condition that in the opinion of the investigator(s) could compromise the patient's ability to comply with study procedures
  • Patients with a BMI <32 at transplant or having weight loss of 20% or more (pre-transplant estimated dry body weight compared to estimated dry body weight at screening)
  • Presence of any other condition that, in the opinion of the investigator(s), could compromise the patient's ability to safely undergo, or benefit from, the SG procedure (eg. significant sarcopenia)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical Intervention; Open Sleeve gastrectomy procedure will be performed immediately following liver transplantation (as a single surgery) or within 2 weeks of transplantation (as a second open surgery)	Procedure: Sleeve gastrectomy; Open sleeve gastrectomy
No Intervention: No Surgical Intervention; Liver transplantation will proceed as per routine practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morbid obesity	rate of morbid obesity defined as BMI greater than or equal to 35	12 months post-liver transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	patient mortality	12 months post-transplant
surgical morbidity	rate of surgical morbidity	12 months post-transplant
surgical morbidity	rate of surgical morbidity	3 months post-transplant
mortality	patient mortality	3 months post-transplant
change in weight	weight loss or gain as percentage of estimated "dry" weight at transplantation	12 months
surgical complications	rate of surgical complications	12 months
sleep apnea	percentage of participants in each group requiring BiPAP or CPAP for treatment of sleep apnea	12 months post-transplantation
hypertension	percentage of participants in each group requiring treatment of hypertension	12 months post-transplantation
diabetes	percentage of participants in each group requiring medical treatment of diabetes	12 months post-transplantation
hyperlipidemia	percentage of participants in each group requiring medical treatment of elevated lipids	12 months post-transplantation

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: David R Grant, M.D., University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2023
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: June 4, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 17-6286

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No