Clinical trial NCT06643689: Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) After Endoscopic Resection for Superficial Neoplasms
Official title: Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) Following Circumferential Endoscopic Submucosal Dissection (cESD) for Superficial Neoplasms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Esophageal Stricture
Esophageal Neoplasms
Keywords: Tranilast
Esophageal Neoplasms
Steroids
Esophageal stricture
Circumferential Endoscopic Submucosal Dissection
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The Third People's Hospital of Hangzhou
name: Xiangya Hospital of Central South University
First posted: 2024-10-16
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: incidence of esophageal stricture within 16 weeks after cESD
timeFrame: 16 weeks
Secondary outcomes:
measure: drug-related side effects
timeFrame: up to 16 weeks
measure: postoperative adverse events
timeFrame: up to 16 weeks
measure: quality of life score EQ-5D
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Third People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing Central Hospital
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Yue Yu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: