- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03039608
Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm
September 3, 2019 updated by: Shanghai Zhongshan Hospital
Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm:a Randomized Controlled Trial
The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently these years especially in Asian countries.
However, besides of perforation and bleeding, another complication postoperative esophageal stricture is frequently observed after the removal of large-sized esophageal neoplasms by ESD.
Dysphagia caused by postoperative stricture substantially decreases the patient's quality of life, requiring further therapy.
Although the exact incidence is unknown, esophageal stricture is supposed to be related to the extent of the circumference being resected.
In previous study by Ono et al,it is reported that 90% of patients with lesions of circumferential extension of more than three-fourths experienced postoperative stricture after esophageal ESD.
There were some reported studies exploring new ways to prevent esophageal stricture after ESD, such as oral prednisolone and local corticosteroid injection.
Corticosteroids can inhibit not only collagen synthesis but also enhance collagen breakdown, thereby inhibiting stricture formation.
Some studies reveled that just oral prednisolone oral is effective option for the prevention of post-ESD stricture.
However, most of the reported studies were non RCTs with small sample.
In the primary study, the investigators search a new method of combination of both oral and local injection to prevent esophageal stricture,as a result,stricture at 8 weeks after ESD was found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the corticosteroid group.
Unfortunately,the study was also retrospective.
So, the investigators plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic effects of combination of local steroid injection with oral steroid administration for esophageal stenoses complicating extensive ESD.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
-
Shanghai, Shanghai, China, 200032
- Zhongshan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who has undergone esophageal ESD
- Histologically confirmed early squamous cell carcinoma or high grade intraepithelial neoplasia of the esophagus
- ESD resulted in a mucosal defect involving more than two-thirds of the esophageal circumference.
Exclusion Criteria:
- Severe circulatory or respiratory disease,severe renal impairment
- Women in pregnancy and lactation
- Patients with steroid contraindications
- Patients refuse to join in this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: combination group
combination of local steroid injection(triamcinolone )with oral steroid administration(prednisone)
|
local steroid injection and oral steroid
|
Active Comparator: control group
oral steroid administration(prednisone)
|
oral steroid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the stricture rate
Time Frame: 12weeks
|
the incidence of esophageal rate after ESD
|
12weeks
|
the time when stricture occurs
Time Frame: 12weeks
|
12weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the frequency of dilatation sessions required
Time Frame: 12 months
|
the frequency of dilatation sessions required after stricture
|
12 months
|
the frequency of complications
Time Frame: 12 months
|
complications related with steroid administrations or the process of ESD
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Meidong Xu, PhD, Shanghai Zhongshan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 10, 2017
Primary Completion (Actual)
July 10, 2018
Study Completion (Actual)
November 10, 2018
Study Registration Dates
First Submitted
January 26, 2017
First Submitted That Met QC Criteria
January 31, 2017
First Posted (Estimate)
February 1, 2017
Study Record Updates
Last Update Posted (Actual)
September 4, 2019
Last Update Submitted That Met QC Criteria
September 3, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Pathological Conditions, Anatomical
- Esophageal Diseases
- Neoplasms
- Constriction, Pathologic
- Esophageal Neoplasms
- Esophageal Stenosis
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
- Triamcinolone
Other Study ID Numbers
- xmdrct
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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