Clinical trial NCT05739162: A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis
Official title: Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity
Ulcerative Colitis
Keywords: ESG
IPAA
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 12
Sex: ALL
Minimum age (years): 22
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Percent total body weight loss
timeFrame: 6 months
measure: Number of subjects with serious adverse events
timeFrame: 24 months
Secondary outcomes:
measure: Number of early peri-operative complications
timeFrame: 1 year following procedure
measure: Number of late peri-operative complications
timeFrame: 1 year following procedure
measure: Change gastrointestinal symptom rating scale (GSRS)
timeFrame: Week 4, Week 12, Week 24, 12 months post-ileostomy takedown
measure: Modified pouchitis disease activity index (mPDAI)
timeFrame: 12 months post-ileostomy takedown
measure: Durable weight loss
timeFrame: 12 months and 12 months post-ileostomy takedown
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amanda M Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: