Phase 2 study of biodegradable stents (BD-stent) for refractory benign esophageal strictures after curative treatment of esophageal cancer

Phase 2

• Conditions: refractory benign esophageal strictures after curative treatment of esophageal cancer

• Registration Number: JPRN-UMIN000008054
• Lead Sponsor: ational Cancer Center Hospital East

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-31
• Study Completion: 2015-07-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1)Delivery system (28F) could not pass the stricture even if any endoscopic dilation was conducted before BD stent insertion. 2)Systemic treatment is indicated for bacterial or fungal infection. 3)Synchronous other cancer except carcinoma in situ, intramucosal carcinoma or watchful waiting prostate cancer. 4)Radiation therapy within 6 months prior to enrollment. 5)Lugol-voiding lesion near the strictures or multiple Lugol-voiding lesion throughout the esophagus. 6)In opioid analgesics therapy. 7)Impossible to discontinue antithrombotic drug. 8)Severe dysphagia. 9)Women during pregnancy or breast-feeding. 10)In chronic treatment with steroids. 11)Patient is judged to be inappropriate for enrollment of the study for any reason by the investigator. 12)Prior treatment using BD stent placement

Study & Design

• Study Type: Interventional
• Study Design: Not specified