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NCT02068872 · ClinicalTrials.gov registry record · Phase 1
Gastric Sleeve Pilot Study in Morbidly Obese Undergoing Liver Transplantation
A Phase 1 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT02068872: Completed Phase 1 study, sponsored by Northwestern University.
NCT02068872 is a Phase 1 study that has completed, run by Northwestern University. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02068872, a Phase 1 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study 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 pr
Primary Outcome
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.
Interventions
- PROCEDURE Sleeve Gastrectomy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2014-02 |
| Est. Completion | 2015-05 |
| Phase | Phase 1 |
What the finished NCT02068872 record still lists
NCT02068872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Sleeve Gastrectomy is the first listed.
NCT02068872 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02068872 about?
NCT02068872 is a clinical study titled "Gastric Sleeve Pilot Study in Morbidly Obese Undergoing Liver Transplantation". 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. L...
What is the current status of trial NCT02068872?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2014-02. Estimated completion is 2015-05.
What interventions are being tested in trial NCT02068872?
The interventions under investigation include: Sleeve Gastrectomy (PROCEDURE).
Who is sponsoring clinical trial NCT02068872?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02068872's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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