Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Percent total body weight loss
Study 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 UC patients undergoing colectomy with eventual IPAA.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Ongoing corticosteroid use at a dose of >5 mg daily
- •Daily use of anti-inflammatory agents such as non-steroidal medications, or anticoagulants without medical supervision
- •Alcohol or drug addiction
- •Females who are pregnant, nursing, or planning pregnancy within the next year
- •Concomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparations
- •Has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk or may interfere significantly with the subject's participation in the study
Arms & Interventions
Endoscopic Sleeve Gastroplasty (ESG)
Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.
Intervention: Lifestyle Intervention (Behavioral)
Endoscopic Sleeve Gastroplasty (ESG)
Participants undergo Endoscopic Sleeve Gastroplasty (ESG). Following the 6-week transitional diet after undergoing the ESG procedure, participants will start the lifestyle intervention.
Intervention: Apollo Endoscopic Suture System (Device)
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
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)
- 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)
Investigators
Amanda M. Johnson
Principal Investigator
Mayo Clinic