Clinical Trials Logo

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03039608
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact
Status Completed
Phase N/A
Start date February 10, 2017
Completion date November 10, 2018

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04372784 - Cryoablation for Benign Gastrointestinal Anastomotic Strictures N/A
Recruiting NCT05581173 - Self-Assembling Matrix Forming Gel to Prevent Stricture Formation
Terminated NCT04406428 - NKI Therapy Compared to Usual Care of Recurrent Esophagogastric Anastomotic Strictures N/A
Recruiting NCT00551824 - Evaluation of Topical Mitomycin C as Adjuvant Drug to Esophageal Dilation in Children N/A
Completed NCT04284826 - Mitomycin-C Injection Therapy in Refractory Esophageal Stricture N/A
Terminated NCT03898661 - Collagenase Clostridium Histolyticum for Refractory Iatrogenic Esophageal Strictures Early Phase 1
Withdrawn NCT04730076 - Balloon Dilation Methods for Benign Esophageal Stricture N/A
Active, not recruiting NCT03885310 - INGEST I Pilot Study N/A
Completed NCT02069847 - Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy Phase 2
Terminated NCT02354716 - EndoFLIP Use in Upper GI Tract Stenosis
Recruiting NCT05561114 - Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus Phase 3
Not yet recruiting NCT04524897 - The Use of Triamcinolone Injection in Treatment of Refractory Benign Esophageal Stricture in Children Phase 4
Not yet recruiting NCT04221867 - Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures (ESOGRAFT) N/A