Status:
COMPLETED
Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Tenwek Hospital, Bomet, Kenya
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Esophageal cancer often causes difficulty swallowing (dysphagia) that can be relieved by placement of a stent (a flexible, expandable tube that props open the blockage caused by the cancer). Stents ar...
Detailed Description
This prospective, randomized study was conducted at Tenwek Hospital in Bomet, Kenya, and was approved by the hospital's institutional review board (IRB) as well as the Kenya Medical Research Institute...
Eligibility Criteria
Inclusion
- age ≥ 18 years
- dysphagia due to unresectable esophageal cancer
- participant resides within 50 km of Tenwek Hospital
- tumor is ≤ 9 cm in length and \> 2 cm distal to the upper esophageal sphincter (UES)
- no esophago-respiratory fistula (ERF) or suspected perforation is present
Exclusion
- unable to provide written informed consent
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01894763
Start Date
September 1 2003
End Date
May 1 2009
Last Update
July 10 2013
Active Locations (1)
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1
Tenwek Hospital
Bomet, Kenya