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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Esophageal Stricture

Intervention / Treatment
-----------------
* Drug: combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）
* Drug: oral steroid administration（prednisone）


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combination group<br>combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone） | Drug: combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）<br>* local steroid injection and oral steroid<br>|
| Active Comparator: control group<br>oral steroid administration（prednisone） | Drug: oral steroid administration（prednisone）<br>* oral steroid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the stricture rate | the incidence of esophageal rate after ESD | 12weeks | 
| the time when stricture occurs |  | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the frequency of dilatation sessions required | the frequency of dilatation sessions required after stricture | 12 months | 
| the frequency of complications | complications related with steroid administrations or the process of ESD | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophageal stricture, endoscopic submucosal dissection, prevention