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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2018-11-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophageal Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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combination group

combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）

Group Type EXPERIMENTAL

combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）

Intervention Type DRUG

local steroid injection and oral steroid

control group

oral steroid administration（prednisone）

Group Type ACTIVE_COMPARATOR

oral steroid administration（prednisone）

Intervention Type DRUG

oral steroid

Interventions

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combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）

local steroid injection and oral steroid

Intervention Type DRUG

oral steroid administration（prednisone）

oral steroid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients who has undergone esophageal ESD
2. Histologically confirmed early squamous cell carcinoma or high grade intraepithelial neoplasia of the esophagus
3. ESD resulted in a mucosal defect involving more than two-thirds of the esophageal circumference.

Exclusion Criteria

1. Severe circulatory or respiratory disease，severe renal impairment
2. Women in pregnancy and lactation
3. Patients with steroid contraindications
4. Patients refuse to join in this study

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No