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

NCT06643689 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2024-1044
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 3

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.

Conditions

Esophageal Stricture; Esophageal Neoplasms

Keywords

Tranilast; Esophageal Neoplasms; Steroids; Esophageal stricture; Circumferential Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

• incidence of esophageal stricture within 16 weeks after cESD

  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 Outcomes (3)

• drug-related side effects

  up to 16 weeks

• postoperative adverse events

  up to 16 weeks

• quality of life score EQ-5D

  16 weeks

Study Arms (2)

Tranilast Treatment Group

EXPERIMENTAL

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

Drug: Tranilast

Steroid Treatment Group

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

Tranilast DRUG

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.

Tranilast Treatment Group

Dexamethasone DRUG

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.

Steroid Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• allergic to tranilast.
• with severe comorbid conditions.
• pregnant or breastfeeding.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The Third People's Hospital of Hangzhou: collaborator
• Xiangya Hospital of Central South University: collaborator

Study Sites (3)

Hangzhou Third People's Hospital

Hangzhou, Zhejiang, 310009, China

Location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Shaoxing Central Hospital

Shaoxing, Zhejiang, 312000, China

Location

MeSH Terms

Conditions

Esophageal Stenosis; Esophageal Neoplasms

Interventions

tranilast; Dexamethasone

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Yue Yu, Dr.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Yu, Dr.

CONTACT

+86 18258868659; 2320065@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-Blind Method with Investigator Blinding Specific blinding measures: 1. Randomization and drug allocation: Randomization and drug allocation should be managed by a third party (e.g., data management team or pharmacist). The treatment options (Tranilast or steroids) should be distributed in identical appearance, packaging, and dosage forms to ensure that the investigators cannot determine the group assignment based on the drug's appearance. 2. Protection of subject information: Ensure that investigators have no access to any information regarding the drug name and group assignment. Anonymous numbers or subject codes can be used for labeling, with only the personnel or system responsible for drug allocation knowing the specific group assignments. 3. Data monitors or independent assessors: Independent monitors or assessors can be introduced, responsible only for follow-up and evaluation of post-procedure stricture, without knowledge of the patients' treatment groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into two parallel groups (Tranilast group and steroid group). Each group will receive their respective treatments concurrently, and outcomes will be assessed independently for each group. This model ensures that participants are not crossed over between treatment arms during the study.

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 16, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 14, 2024

Record last verified: 2024-10

Locations

CN (3)