Gastric Sleeve Pilot Study in Morbidly Obese Undergoing Liver Transplantation

NCT02068872 | Completed Phase 1

• 1 other identifier: STU00076284
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The rapid rise in obesity (body mass index (BMI) ≥ 30 kg/m2) in the US over the past decade is responsible for more disease and death than any other single factor. Severe obesity is associated with numerous co-morbidities contributing to increased mortality risk, including end stage liver disease. Liver transplantation is a life-saving procedure for patients with end stage liver disease and obesity is becoming increasingly prevalent in this population. In one study, 54% of patients undergoing orthotopic liver transplant (OLT) were either overweight or obese \[body mass index (BMI) \>25 kg/m2\], and 7% were severely or morbidly obese (BMI \> 35 kg/m2). In addition, weight gain after solid organ transplantation is common because of steroid-containing immunosuppression and physical inactivity from decreased exercise tolerance. Obesity has been shown to increase the surgical morbidity, including wound infections, wound dehiscence, and hernias after transplantation. More significantly, excess pretransplant body weight hinders the rate of improvement in health-related quality of life after liver transplantation\[7\]. One possible approach for treating obesity after a liver transplant is to use bariatric surgery. Currently, bariatric surgery is established as the most effective means for both weight loss and resolution of metabolic disease in the morbidly obese. Recent publications emphasize the usefulness of bariatric surgery in the reduction of long-term cardiometabolic risk, cardiovascular disease incidence and mortality, and the management of uncontrolled type 2 diabetes (T2DM). In addition, it decreases mortality and improves both social functioning and quality of life. Bariatric surgery may improve eligibility for transplant in patients previously excluded due to excessive weight. Bariatric procedures, such as sleeve gastrectomy, allow for significant weight loss over time that greatly reduces or eliminates obesity related illnesses such as diabetes, high blood pressure and liver disease. According to the National Institutes of Health, bariatric surgery is reserved for patients with a BMI of \> 40 or \> 35 kg/m2 in the presence of major co-morbidities (e.g. type 2 diabetes, hypertension, sleep apnea, heart disease, etc). A significant number of liver transplant candidates have obesity-related illnesses, thus putting them at risk for cardiovascular and metabolic complications post-transplant. In addition, patients awaiting OLT are typically no longer medically stable to undergo intensive diet and exercise regimens as treatment for their diseases. Finally, decreased activity and medications used to prevent liver graft rejection all contribute to increased weight gain following transplant. In fact, in a series of 320 non-obese liver transplant recipients, 21.6% of patients became obese within two years of transplant. These comorbidities also contribute to poorer post-transplant outcomes and development of what is known as the post-transplant metabolic syndrome. Morbidly obese patients (BMI \> 40 kg/m2) may also have higher frequencies of morbidities such as prolonged hospitalization and readmission as well as infectious, wound, and cardiovascular complications after transplantation. Finally, intra-abdominal adiposity creates a technically more challenging operative dissection, but no data exist on whether it increases perioperative morbidity or mortality in liver transplant patients. Sleeve gastrectomy is the most attractive restrictive procedure in a liver transplant population for several key reasons. One, sleeve gastrectomy does not require the implantation of a foreign body, such as placement of an adjustable gastric band, which in an immunocompromised post-transplant patient raises concern for severe infectious complications. Secondly, as stated previously, sleeve gastrectomy is a purely restrictive procedure, and therefore is least likely to cause significant macronutrient and micronutrient deficiencies. Finally, when compared to other restrictive procedures, such as adjustable gastric band placement, it has a lower likelihood of treatment failure (i.e. \<50% excess weight loss). In fact, recent reports describe not only high failure rates with adjustable gastric band placement, but also high reintervention rates for both band-related complications (e.g. band erosion, leakage, slippage, port infection and esophageal dilatation) and failure to lose weight such that as few as 54% of patients may have their band in place after 10 years.

Conditions

Obesity; Cardiovascular Disease; Type 2 Diabetes; Hypertension; Complication of Transplant

Keywords

Obesity; Transplant; Sleeve Gastrectomy; Liver Transplantation; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Safety of Sleeve Gastrectomy

  The primary endpoint is the safety of sleeve gastrectomy during liver transplant as measured by adverse event rates, infectious complications and length of hospital stay compared to UNOS and institutional data.

  Expected duration of subject participation is 1 year

Secondary Outcomes (1)

• Weight Loss

  6 months after transplant

Study Arms (1)

Sleeve Gastrectomy

EXPERIMENTAL

To assess the safety, tolerability and feasibility of sleeve gastrectomy in the perioperative period following liver transplantation in obese (BMI of \> 40 or \> 35 kg/m2 in the presence of at least one major obesity related co-morbidities (e.g. type 2 diabetes, hypertension, sleep apnea, heart disease, etc) adult subjects aged 18-75 years of age.

Procedure: Sleeve Gastrectomy

Interventions

Sleeve Gastrectomy PROCEDURE

To assess the safety, tolerability and feasibility of sleeve gastrectomy in the perioperative period following liver transplantation in obese (BMI of \> 40 or \> 35 kg/m2 in the presence of at least one major obesity related co-morbidities (e.g. type 2 diabetes, hypertension, sleep apnea, heart disease, etc) adult subjects aged 18-75 years of age.

Also known as: Gastric Sleeve

Sleeve Gastrectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be willing to give written informed consent.
• Adult subjects 18-75 years of age of any race or gender who are listed for liver transplantation.
• For consideration of sleeve gastrectomy placement patients must meet the following criteria:
• \. Class III Obesity (BMI ≥ 40 kg/m2); or 2. Class II Obesity (BMI 35-39.9 kg/m2 in conjunction with any of the following severe obesity related co-morbidities): i. Obstructive sleep apnea defined as a formal sleep study consistent with this diagnosis with a) an Epworth sleepiness scale ≥ 6 and b) polysomnography with respiratory disturbance index ≥ 10 and/or apneic episodes per hour of sleep; or ii. Cardiovascular disease defined as prior history of stroke, myocardial infarction, stable or unstable angina pectoris, or prior coronary artery bypass); or iii. Medically refractory hypertension defined as blood pressure greater than 140 mmHg systolic and/or 90 mmHg diastolic despite concurrent use of 3 anti-hypertensive agents of different classes iv. Type 2 diabetes mellitus, defined as individuals taking insulin or oral hypoglycemic agents or who have a fasting glucose \> 126 mg/dL 2. Have attempted (and failed) previous weight loss efforts over at least a three month period with diet, exercise, lifestyle changes or medications.
• \. Show understanding of the risks and benefits of surgery and side effects of the procedure.
• \. Be committed to lifestyle changes. All patients will be evaluated by the transplant psychologist as well as the bariatric surgery psychologist prior to consideration for study enrollment to ensure appropriate psychological motivation.
• \. Do not have any medical, psychiatric or emotional condition that would prohibit surgery (e.g. severe irreversible coronary artery disease, untreated schizophrenia, active substance abuse, and/or noncompliance with previous medical care)

You may not qualify if:

• Status 1 listing (fulminant hepatic failure) for liver transplant
• Active drug abuse or alcohol use within six months
• Positive urine pregnancy test (females)
• Diagnosis of active malignancy
• History of prior bariatric surgery
• Failure to attend the initial patient information sessions or history of noncompliance
• Failure to give consent for the study or to understand the proposed consent
• Failure of patient's insurance company to approve surgical intervention so as to avoid extensive cost burden on the patient

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Obesity; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Hypertension; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Body Weight Changes

Study Officials

• Mary Rinella, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 21, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2015
• Last Updated: October 2, 2015

Record last verified: 2015-09

Locations

US (1)