Skip to content

Effect of cholestyramine on post-ESD ulcer healing

An open-label randomized controlled trial to evaluate post-operative ulcer healing with cholestyramine under PPIs in patients with early gastric cancer ESD

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200235
Enrollment
100
Registered
2020-12-09
Start date
2021-03-08
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric post-ESD ulcers Gastric post-ESD ulcers

Interventions

In addition to the usual treatment (esomeprazole 20 mg 1T1x morning dose), cholestyramine 8g2x morning and evening for 4 weeks.

Sponsors

Tamura Shigeki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients between the ages of 20 and 85 years old at the time of obtaining consent. 2) Patients with early stage gastric cancer or gastric adenoma who are eligible for ESD 3) Patients with written consent from the individual to participate in this study.

Exclusion criteria

Exclusion criteria: 1) Patients with two or more gastric lesions to be resected in pieces in a single treatment (excluding en bloc resection). 2) Patients with psychosis, alcoholism, drug addiction, or drug addiction that may affect compliance with the research protocol. 3) Patients who are breastfeeding or who may be pregnant 4) Patients with biliary atresia or hypersensitivity 5) Patients with intestinal obstruction and the cause of the obstruction is not yet known or treated. 6) Patients on oral statins 7) Patients taking cholestyramine or cholestimide 8) Other patients who are judged by the principal investigator to be unsuitable as subjects for this study. 9) Patients who are taking NSAIDs on time

Design outcomes

Primary

MeasureTime frame
Rate of ulcer healing at 4-5 weeks after ESD

Secondary

MeasureTime frame
Post ESD ulcer status (Forrest classification), intragastric bile acid concentration, gastric juice color, Frequency of posterior bleeding, rate of ulcer size reduction, and frequency of adverse events

Contacts

Public ContactShigeki Tamura

Yokohama City University Hospital

tamura.shi.gs@yokohama-cu.ac.jp+81-45-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026