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Clinical Trials/JPRN-UMIN000008054
JPRN-UMIN000008054
Completed
Phase 2

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

ational Cancer Center Hospital East0 sites20 target enrollmentMay 31, 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
ational Cancer Center Hospital East
Enrollment
20
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 31, 2012
End Date
July 1, 2015
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ational Cancer Center Hospital East

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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