Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) After Endoscopic Resection for Superficial Neoplasms
NCT ID: NCT06643689
Last Updated: 2024-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
394 participants
INTERVENTIONAL
2025-01-01
2028-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
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.
Study Groups
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Tranilast Treatment Group
Participants in this group will receive Tranilast for the prevention of stricture after cESD of superficial esophageal tumors.
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.
Steroid Treatment Group
Participants in this group will receive steroids for the prevention of stricture after cESD of superficial esophageal tumors.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. underwent cESD treatment for superficial esophageal neoplasms.
3. agree to sign an informed consent form.
Exclusion Criteria
2. with severe comorbid conditions.
3. pregnant or breastfeeding.
18 Years
ALL
No
Sponsors
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The Third People's Hospital of Hangzhou
OTHER
Xiangya Hospital of Central South University
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Yue Yu, Dr.
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Yufang Wang, Master of Medicine
Role: backup
Yue Yu, Dr.
Role: backup
Litao Jia, Dr.
Role: backup
Yingchao Sun, Master of Medicine
Role: backup
Other Identifiers
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2024-1044
Identifier Type: -
Identifier Source: org_study_id
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