Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation (SG-4MOST)
Primary Purpose
Liver Transplantation, Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sleeve gastrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Liver Transplantation
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Surgical Intervention
No Surgical Intervention
Arm Description
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)
Liver transplantation will proceed as per routine practice
Outcomes
Primary Outcome Measures
morbid obesity
rate of morbid obesity defined as BMI greater than or equal to 35
Secondary Outcome Measures
mortality
patient mortality
surgical morbidity
rate of surgical morbidity
surgical morbidity
rate of surgical morbidity
mortality
patient mortality
change in weight
weight loss or gain as percentage of estimated "dry" weight at transplantation
surgical complications
rate of surgical complications
sleep apnea
percentage of participants in each group requiring BiPAP or CPAP for treatment of sleep apnea
hypertension
percentage of participants in each group requiring treatment of hypertension
diabetes
percentage of participants in each group requiring medical treatment of diabetes
hyperlipidemia
percentage of participants in each group requiring medical treatment of elevated lipids
Full Information
NCT ID
NCT03617744
First Posted
June 4, 2018
Last Updated
May 19, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03617744
Brief Title
Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation
Acronym
SG-4MOST
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomization to group a or group b
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical Intervention
Arm Type
Experimental
Arm Description
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)
Arm Title
No Surgical Intervention
Arm Type
No Intervention
Arm Description
Liver transplantation will proceed as per routine practice
Intervention Type
Procedure
Intervention Name(s)
Sleeve gastrectomy
Intervention Description
Open sleeve gastrectomy
Primary Outcome Measure Information:
Title
morbid obesity
Description
rate of morbid obesity defined as BMI greater than or equal to 35
Time Frame
12 months post-liver transplant
Secondary Outcome Measure Information:
Title
mortality
Description
patient mortality
Time Frame
12 months post-transplant
Title
surgical morbidity
Description
rate of surgical morbidity
Time Frame
12 months post-transplant
Title
surgical morbidity
Description
rate of surgical morbidity
Time Frame
3 months post-transplant
Title
mortality
Description
patient mortality
Time Frame
3 months post-transplant
Title
change in weight
Description
weight loss or gain as percentage of estimated "dry" weight at transplantation
Time Frame
12 months
Title
surgical complications
Description
rate of surgical complications
Time Frame
12 months
Title
sleep apnea
Description
percentage of participants in each group requiring BiPAP or CPAP for treatment of sleep apnea
Time Frame
12 months post-transplantation
Title
hypertension
Description
percentage of participants in each group requiring treatment of hypertension
Time Frame
12 months post-transplantation
Title
diabetes
Description
percentage of participants in each group requiring medical treatment of diabetes
Time Frame
12 months post-transplantation
Title
hyperlipidemia
Description
percentage of participants in each group requiring medical treatment of elevated lipids
Time Frame
12 months post-transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Winter, BSc
Phone
416-340-4800
Ext
6093
Email
erin.winter@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Grant, M.D.
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation
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