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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• incidence of esophageal stricture within 16 weeks after cESD [Срок оценки: 16 weeks]

Вторичные конечные точки (3)

• drug-related side effects [Срок оценки: up to 16 weeks]
• postoperative adverse events [Срок оценки: up to 16 weeks]
• quality of life score EQ-5D [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 3 центра

• Hangzhou Third People's Hospital — Ханчжоу
• The Second Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу
• Shaoxing Central Hospital — Shaoxing

Идентификаторы

NCT: NCT06643689 · 2024-1044

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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