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

Completed NA Last updated 4 September 2019

What this trial tests

NA trial testing combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone） in Esophageal Stricture in 72 participants. Completed in 10 November 2018.

Timeline

10 February 2017

Primary endpoint
10 July 2018

10 November 2018

Quick facts

Lead sponsor	Shanghai Zhongshan Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	72
Start date	10 February 2017
Primary completion	10 July 2018
Estimated completion	10 November 2018
Sites	1 location across China

Drugs / interventions tested

• combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone） — full drug profile →
• oral steroid administration（prednisone） — full drug profile →

Conditions studied

• Esophageal Stricture — all drugs for Esophageal Stricture →

Sponsor

Shanghai Zhongshan Hospital

Who can join

Adults 18 to 75, any sex, with Esophageal Stricture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.