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

November 12, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) Following Circumferential Endoscopic Submucosal Dissection (cESD) for Superficial Neoplasms

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Esophageal strictures are a frequent complication after cESD for superficial esophageal tumors, which significantly affects patients' quality of life and often necessitates repeated endoscopic interventions. Currently, steroids are widely used to prevent post-cESD strictures, but their side effects, including increased risks of infection and delayed wound healing, limit their use. Tranilast, an anti-inflammatory and antifibrotic agent, has shown potential in preventing fibrosis in preclinical studies, but its clinical efficacy in preventing esophageal stricture after cESD remains unclear.

This randomized, parallel, single-blinded non-inferiority trial aims to compare the efficacy and safety of tranilast with steroids in preventing esophageal strictures post-cESD. The primary outcome is the incidence of esophageal stricture within 16 weeks after cESD. It is a composite outcome defined as the inability to pass a standard endoscope (diameter 10.8 mm) through the stricture site at 16 weeks, or the presence of clinical symptoms of esophageal stricture (such as difficulty swallowing solid food) occurring before the endoscopic assessment at 16 weeks. Secondary outcomes include drug-related side effects, postoperative adverse events, and quality of life scores. This study will provide valuable insights into whether tranilast can serve as an effective and safer alternative to corticosteroids in this setting.

Study Type

Interventional

Enrollment (Estimated)

394

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • the second Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
        • Contact:
          • Yue Yu, Dr.
        • Contact:
          • Litao Jia, Dr.
      • Hangzhou, Zhejiang, China, 310009
        • Hangzhou Third People's Hospital
        • Contact:
        • Contact:
          • Yufang Wang, Master of Medicine
      • Shaoxing, Zhejiang, China, 312000
        • Shaoxing Central Hospital
        • Contact:
          • Yingchao Sun, Master of Medicine
          • Phone Number: +86 575 8519 0114
          • Email: szxyy@163.com
        • Contact:
          • Yingchao Sun, Master of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age>18 and proficient in Mandarin.
  2. underwent cESD treatment for superficial esophageal neoplasms.
  3. agree to sign an informed consent form.

Exclusion Criteria:

  1. allergic to tranilast.
  2. with severe comorbid conditions.
  3. pregnant or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranilast Treatment Group
Participants in this group will receive Tranilast for the prevention of stricture after cESD of superficial esophageal tumors.
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.
Active Comparator: Steroid Treatment Group
Participants in this group will receive steroids for the prevention of stricture after cESD of superficial esophageal tumors.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of esophageal stricture within 16 weeks after cESD
Time Frame: 16 weeks
a composite outcome defined as the inability to pass a standard endoscope (diameter 10.8 mm) through the stricture site, or the presence of clinical symptoms of esophageal stricture, such as difficulty swallowing solid food, occurring before the endoscopic assessment at 16 weeks.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
drug-related side effects
Time Frame: up to 16 weeks
Occurrence of side effects directly related to tranilast or steroid treatment, as assessed by clinical monitoring and patient reports. These may include gastrointestinal discomfort, allergic reactions, infection, hepatic and renal function impairment, or other systemic effects.
up to 16 weeks
postoperative adverse events
Time Frame: up to 16 weeks
Occurrence of any adverse events post-surgery, including bleeding, infection, perforation, or other complications. Events will be documented and classified according to the Common Terminology Criteria for Adverse Events.
up to 16 weeks
quality of life score EQ-5D
Time Frame: 16 weeks
Assess change in Quality of Life (QoL) Score. Patient-reported quality of life, measured using a validated QoL questionnaire to assess the impact of treatment on daily functioning and well-being. Changes in QoL score from baseline to 16 weeks post-treatment will be evaluated.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Xiangya Hospital of Central South University
The Third People's Hospital of Hangzhou

Investigators

  • Principal Investigator: Yue Yu, Dr., Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The decision regarding the sharing of individual participant data is currently pending further assessment of data protection laws and privacy concerns. We are also awaiting approval from the ethics committee before making a final decision.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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