Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)

Mayo Clinic1 site in 1 country24 target enrollmentSeptember 20, 2023

ConditionsObesity Ulcerative Colitis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Mayo Clinic
Enrollment: 24
Locations: 1
Primary Endpoint: Percent total body weight loss
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese ulcerative colitis (UC) patients undergoing colectomy with eventual Ileal Pouch Anal Anastomosis (IPAA) compared to counseling on diet and lifestyle interventions alone.

Registry

clinicaltrials.gov

Start Date

September 20, 2023

End Date

January 1, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Amanda M. Johnson

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•BMI 30-50 kg/m2 for at least 6 months prior to ESG
•Diagnosis of UC with plans to undergo or who have already undergone colectomy as part of a plan to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA)
•Willing to adhere to the diet and behavior modifications required for ESG
•Able to follow the visit schedule
•Able to provide informed consent
•If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum Human Chorionic Gonadotropin (HCG) at screening/baseline

Exclusion Criteria

•Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG
•Current or recent (last six months) gastric or duodenal ulceration
•Esophageal or gastric varices
•Significant motility disorder of the esophagus or stomach
•Large hiatal hernia measuring \>5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux
•Severe coagulopathy, hepatic insufficiency, or cirrhosis
•Gastric mass
•Presence of any other medical condition which precludes safe performance of elective endoscopy such as poor general health and/or history of severe hepatic, cardiac, or pulmonary disease
•Serious or uncontrolled psychiatric illness which may compromise patient understanding of procedure or compliance with follow-up visits
•Unwilling to participate in an established diet and behavior modification program, with routine follow-up

Outcomes

Primary Outcomes

Percent total body weight loss

Time Frame: 6 months

Percent total body weight loss (%TBWL) calculated by the equation ((baseline screening weight in kilograms (kg) subtracted by follow-up weight in kg) divided by baseline screening weight in kg) times 100.

Number of subjects with serious adverse events

Time Frame: 24 months

Total number of subjects to report serious adverse event related to the ESG procedure

Secondary Outcomes

Number of early peri-operative complications(1 year following procedure)
Number of late peri-operative complications(1 year following procedure)
Change gastrointestinal symptom rating scale (GSRS)(Week 4, Week 12, Week 24, 12 months post-ileostomy takedown)
Modified pouchitis disease activity index (mPDAI)(12 months post-ileostomy takedown)
Durable weight loss(12 months and 12 months post-ileostomy takedown)