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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

Qualifiers

age>18 and proficient in Mandarin.

underwent cESD treatment for superficial esophageal neoplasms.

agree to sign an informed consent form.

Disqualifiers

allergic to tranilast.

with severe comorbid conditions.

pregnant or breastfeeding.

Trial design

Treatments tested in this trial

  • Tranilast
  • Dexamethasone

Treatment groups

394 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

The Third People's Hospital of Hangzhou

Collaborator

Xiangya Hospital of Central South University

Collaborator