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

Zhejiang University

Status and phase: Not yet enrolling; Phase 2

Conditions: Esophageal Stricture; Esophageal Neoplasms

Treatments: Drug: Tranilast; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06643689

2024-1044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 394 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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394 participants in 2 patient groups

Tranilast Treatment Group

Experimental group

Description:

Participants in this group will receive Tranilast for the prevention of stricture after cESD of superficial esophageal tumors.

Treatment:

Drug: Tranilast

Steroid Treatment Group

Active Comparator group

Description:

Participants in this group will receive steroids for the prevention of stricture after cESD of superficial esophageal tumors.

Treatment:

Drug: Dexamethasone