Trial Title:
Tranilast vs. Steroids to Prevent Esophageal Stricture (TAPES) After Endoscopic Resection for Superficial Neoplasms
NCT ID:
NCT06643689
Condition:
Esophageal Stricture
Esophageal Neoplasms
Conditions: Official terms:
Neoplasms
Esophageal Neoplasms
Esophageal Stenosis
Constriction, Pathologic
Tranilast
Dexamethasone
Conditions: Keywords:
Tranilast
Esophageal Neoplasms
Steroids
Esophageal stricture
Circumferential Endoscopic Submucosal Dissection
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
Single-Blind Method with Investigator Blinding
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.
Intervention:
Intervention type:
Drug
Intervention name:
Tranilast
Description:
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.
Arm group label:
Tranilast Treatment Group
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
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.
Arm group label:
Steroid Treatment Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hangzhou Third People's Hospital
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Contact:
Last name:
Yufang Wang, Master of Medicine
Phone:
+86 571 87062660
Email:
hzyy@hzhospital.com
Investigator:
Last name:
Yufang Wang, Master of Medicine
Email:
Principal Investigator
Facility:
Name:
The Second Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Contact:
Last name:
Yue Yu, Dr.
Phone:
+86 18258868659
Email:
2320065@zju.edu.cn
Investigator:
Last name:
Yue Yu, Dr.
Email:
Principal Investigator
Investigator:
Last name:
Litao Jia, Dr.
Email:
Sub-Investigator
Facility:
Name:
Shaoxing Central Hospital
Address:
City:
Shaoxing
Zip:
312000
Country:
China
Contact:
Last name:
Yingchao Sun, Master of Medicine
Phone:
+86 575 8519 0114
Email:
szxyy@163.com
Investigator:
Last name:
Yingchao Sun, Master of Medicine
Email:
Principal Investigator
Start date:
January 1, 2025
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
The Third People's Hospital of Hangzhou
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Source:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06643689
