Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643689
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Tranilast vs Steroids to Prevent Esophageal Stricture TAPES After Endoscopic Resection for Superficial Neoplasms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tranilast vs Steroids to Prevent Esophageal Stricture TAPES Following Circumferential Endoscopic Submucosal Dissection cESD for Superficial Neoplasms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAPES
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
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 108 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
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 108 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None