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

Esophageal Stricture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039608
• Other study ID #: xmdrct
• Status: Completed
• Phase: N/A
• Start date: February 10, 2017
• Est. completion date: November 10, 2018

Study information

• Verified date: September 2019
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 10, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Esophageal Neoplasms
• Esophageal Stenosis
• Esophageal Stricture
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the stricture rate	the incidence of esophageal rate after ESD	12weeks
Primary	the time when stricture occurs		12weeks
Secondary	the frequency of dilatation sessions required	the frequency of dilatation sessions required after stricture	12 months
Secondary	the frequency of complications	complications related with steroid administrations or the process of ESD	12 months