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Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) After Endoscopic Resection for Superficial Neoplasms

NCT06643689 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 394

Last updated 2024-11-14

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if tranilast works to prevent esophageal stricture after circumferential endoscopic submucosal dissection (cESD) in adults. It will also help us learn more about the safety of tranilast. The main questions it aims to answer are: 1. Does tranilast reduce the occurence of esophageal stricture in participants after cESD? 2. What medical problems do participants have when taking tranilast.

Researchers will compare tranilast to prednisone (a steroid used in clinical practice with potential defects) to see if tranilast works well to prevent esophageal stricture.

Participants will: 1. Take tranilast or prednisone every day for 8 weeks. 2. Attend visit (at clinic or phone) once every 2 weeks for checkups and tests until 16 weeks. 3. Keep a diary of their symptoms and let researchers know during the 16 weeks follow up.

Conditions

  • Esophageal Stricture
  • Esophageal Neoplasms

Interventions

DRUG

Tranilast

Tranilast is an anti-allergic agent that is hypothesized to prevent stricture formation in patients undergoing cESD for superficial esophageal tumors. Participants in this group will receive 100 mg orally three times a day for 8 weeks.

DRUG

Dexamethasone

Prednisone is a corticosteroid used to reduce inflammation and prevent stricture in patients undergoing cESD for superficial esophageal tumors. Participants in this group will receive an oral dose of 30 mg once daily for 8 weeks, with a gradual tapering of the dosage as follows: Weeks 1-2: 30 mg daily; Weeks 3-4: 25 mg daily; Weeks 5-6: 20 mg daily; Weeks 7-8: 15 mg daily; and then tapering to 10 mg daily in Week 7 and 5 mg daily in Week 8.

Sponsors & Collaborators

  • The Third People's Hospital of Hangzhou

    collaborator OTHER

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Yue Yu, Dr. · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06643689 on ClinicalTrials.gov