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

Phase 2

Not yet recruiting

• Conditions: Esophageal Stricture; Esophageal Neoplasms
• Interventions: Drug: Tranilast; Drug: Dexamethasone

• Registration Number: NCT06643689
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-15
• Study First Posted: 2024-10-16
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14
• Study Start: 2025-01-01
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 394

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranilast Treatment Group	Tranilast	Participants in this group will receive Tranilast for the prevention of stricture after cESD of superficial esophageal tumors.
Steroid Treatment Group	Dexamethasone	Participants in this group will receive steroids for the prevention of stricture after cESD of superficial esophageal tumors.

Primary Outcome Measures

Name	Time	Method
incidence of esophageal stricture within 16 weeks after cESD	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.

Secondary Outcome Measures

Name	Time	Method
drug-related side effects	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.
postoperative adverse events	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.
quality of life score EQ-5D	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.

Trial Locations

Locations (3)

Hangzhou Third People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

The Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Shaoxing Central Hospital; 🇨🇳 Shaoxing, Zhejiang, China