Sleeve Gastrectomy for Morbid-Obesity Sequelae After Transplantation
- Conditions
- ObesityLiver Transplantation
- Interventions
- Procedure: Sleeve gastrectomy
- Registration Number
- NCT03617744
- Lead Sponsor
- University Health Network, Toronto
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
-
• 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgical Intervention Sleeve gastrectomy 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)
- Primary Outcome Measures
Name Time Method morbid obesity 12 months post-liver transplant rate of morbid obesity defined as BMI greater than or equal to 35
- Secondary Outcome Measures
Name Time Method mortality 3 months post-transplant patient mortality
surgical morbidity 3 months post-transplant rate of surgical morbidity
change in weight 12 months weight loss or gain as percentage of estimated "dry" weight at transplantation
surgical complications 12 months rate of surgical complications
sleep apnea 12 months post-transplantation percentage of participants in each group requiring BiPAP or CPAP for treatment of sleep apnea
hypertension 12 months post-transplantation percentage of participants in each group requiring treatment of hypertension
diabetes 12 months post-transplantation percentage of participants in each group requiring medical treatment of diabetes
hyperlipidemia 12 months post-transplantation percentage of participants in each group requiring medical treatment of elevated lipids