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

NCT03039608 | Completed

• 1 other identifier: xmdrct
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Stricture

Keywords

esophageal stricture; endoscopic submucosal dissection; prevention

Outcome Measures

Primary Outcomes (2)

• the stricture rate

  the incidence of esophageal rate after ESD

  12weeks

• the time when stricture occurs

  12weeks

Secondary Outcomes (2)

• the frequency of dilatation sessions required

  12 months

• the frequency of complications

  12 months

Study Arms (2)

combination group

EXPERIMENTAL

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

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

control group

ACTIVE COMPARATOR

oral steroid administration（prednisone）

Drug: oral steroid administration（prednisone）

Interventions

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

local steroid injection and oral steroid

combination group

oral steroid administration（prednisone） DRUG

oral steroid

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe circulatory or respiratory disease，severe renal impairment
• Women in pregnancy and lactation
• Patients with steroid contraindications
• Patients refuse to join in this study

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Esophageal Stenosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Meidong Xu, PhD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: February 1, 2017
• Study Start: February 10, 2017
• Primary Completion: July 10, 2018
• Study Completion: November 10, 2018
• Last Updated: September 4, 2019

Record last verified: 2019-09

Locations

CN (1)