Esophageal StricturePhase 2TAPESNCT06643689
Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) After Endoscopic Resection for Superficial Neoplasms
A Phase 2 study testing Tranilast and Dexamethasone in people with Esophageal Stricture and Esophageal Neoplasms, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Stricture, Esophageal Neoplasms
- What is being tested?
- Tranilast and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2025to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age>18 and proficient in Mandarin.
- underwent cESD treatment for superficial esophageal neoplasms.
- agree to sign an informed consent form.
Who cannot join
- allergic to tranilast.
- with severe comorbid conditions.
- pregnant or breastfeeding.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, 310009
Yufang Wang, Master of Medicine, +86 571 87062660, hzyy@hzhospital.com
Yufang Wang, Master of Medicine
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Yue Yu, Dr., +86 18258868659, 2320065@zju.edu.cn
Yue Yu, Dr.
Shaoxing Central Hospital
Shaoxing, Zhejiang, 312000
Yingchao Sun, Master of Medicine, +86 575 8519 0114, szxyy@163.com
Yingchao Sun, Master of Medicine
About this study
Official title: Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) Following Circumferential Endoscopic Submucosal Dissection (cESD) for Superficial Neoplasms
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.
Read the 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.
- Conditions
- Esophageal Stricture, Esophageal Neoplasms
- Being tested
- Tranilast, Dexamethasone
- Keywords
- Tranilast, Esophageal Neoplasms, Steroids, Esophageal stricture, Circumferential Endoscopic Submucosal Dissection
- Medical subject headings
- Esophageal Stenosis, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TranilastDrug
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.
DexamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tranilast Treatment Group | Experimental | Participants in this group will receive Tranilast for the prevention of stricture after cESD of superficial esophageal tumors. Receives: Drug: Tranilast |
| Steroid Treatment Group | Active comparator | Participants in this group will receive steroids for the prevention of stricture after cESD of superficial esophageal tumors. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of esophageal stricture within 16 weeks after cESD
a composite outcome defined as the inability to pass a standard endoscope (diameter 10.8 mm) through the stricture site, or the presence of clinical symptoms of esophageal stricture, such as difficulty swallowing solid food, occurring before the endoscopic assessment at 16 weeks.
Measured: 16 weeks
Secondary outcomes (3)
drug-related side effects
Occurrence of side effects directly related to tranilast or steroid treatment, as assessed by clinical monitoring and patient reports. These may include gastrointestinal discomfort, allergic reactions, infection, hepatic and renal function impairment, or other systemic effects.
Measured: up to 16 weeks
postoperative adverse events
Occurrence of any adverse events post-surgery, including bleeding, infection, perforation, or other complications. Events will be documented and classified according to the Common Terminology Criteria for Adverse Events.
Measured: up to 16 weeks
quality of life score EQ-5D
Assess change in Quality of Life (QoL) Score. Patient-reported quality of life, measured using a validated QoL questionnaire to assess the impact of treatment on daily functioning and well-being. Changes in QoL score from baseline to 16 weeks post-treatment will be evaluated.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StrictureStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Third People's Hospital of Hangzhou, Xiangya Hospital of Central South University
- Responsible party
- Sponsor
- Investigators
- Yue Yu, Dr., Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643689
- Sponsor's protocol ID
- 2024-1044
- Acronym
- TAPES
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding the sharing of individual participant data is currently pending further assessment of data protection laws and privacy concerns. We are also awaiting approval from the ethics committee before making a final decision.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranilast Vs. Steroids to Prevent Esophageal Stricture (TAPES) Following Circumferential Endoscopic Submucosal Dissection (cESD) for Superficial Neoplasms
- ClinicalTrials.gov ID
- NCT06643689
- Acronym / sponsor ID
- TAPES / 2024-1044
- Conditions
- Esophageal Stricture, Esophageal Neoplasms
- Keywords
- Tranilast, Esophageal Neoplasms, Steroids, Esophageal stricture, Circumferential Endoscopic Submucosal Dissection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Third People's Hospital of Hangzhou, Xiangya Hospital of Central South University
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tranilast Treatment Group | Experimental | Drug: TranilastParticipants in this group will receive Tranilast for the prevention of stricture after cESD of superficial esophageal tumors. |
| Steroid Treatment Group | Active comparator | Drug: DexamethasoneParticipants in this group will receive steroids for the prevention of stricture after cESD of superficial esophageal tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age>18 and proficient in Mandarin.
- underwent cESD treatment for superficial esophageal neoplasms.
- agree to sign an informed consent form.
Key exclusion criteria (3 listed)
- allergic to tranilast.
- with severe comorbid conditions.
- pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TranilastTranilast 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. | Drug | Tranilast Treatment Group |
| DexamethasonePrednisone 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. | Drug | Steroid Treatment Group |
Primary outcome
incidence of esophageal stricture within 16 weeks after cESD
Time frame: 16 weeks
a composite outcome defined as the inability to pass a standard endoscope (diameter 10.8 mm) through the stricture site, or the presence of clinical symptoms of esophageal stricture, such as difficulty swallowing solid food, occurring before the endoscopic assessment at 16 weeks.
3 secondary outcomes
drug-related side effects
Time frame: up to 16 weeks
postoperative adverse events
Time frame: up to 16 weeks
quality of life score EQ-5D
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: Undecided. The decision regarding the sharing of individual participant data is currently pending further assessment of data protection laws and privacy concerns. We are also awaiting approval from the ethics committee before making a final decision.
Related trials for Esophageal Stricture
Enrolling by invitation
Adipose-derived Stem Cells in Treatment of Esophageal Strictures
Esophageal Stenosis Acquired
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Prospective Evaluation of AI-ECG for SHD Detection
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
RecruitingObservational study
Abbott Cephea Mitral Valve Disease Registry
Mitral Regurgitation, Mitral Stenosis
Recruiting
Impact of Body Positioning on EndoFLIP Measurements: A Comparative Study of Supine and Left Lateral Decubitus Positions
Dysphagia, Esophageal Stricture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yue Yu, Dr. principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranilast and Dexamethasone in people with Esophageal Stricture and Esophageal Neoplasms, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Yu, Dr. (+86 18258868659, 2320065@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of esophageal stricture within 16 weeks after cESD (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.