A prospective randomized study of "covered" vs "uncovered" metallic stents for the management of biliary stricture by unresectable pancreatic cancer.

Phase 3

• Conditions: Biliary stricture caused by unresectable pancreatic cancer

• Registration Number: JPRN-UMIN000009778
• Lead Sponsor: Kansai Endoscopic Device Selection (EDS) Working Group

Brief Summary

Patient survival time in the two groups did not signifi cantly differ (median: 285 and 223 days, respectively; P = 0.68). Patient survival time without stent dysfunction was signifi cantly longer in the covered than in the uncovered SEMS group (median: 187 vs. 132 days; P = 0.043).Stent patency was also signifi cantly longer in the covered than in the uncovered SEMS group (mean +- s.d.: 219.3 +- 159.1 vs. 166.9 +- 124.9 days; P = 0.047).Rates of tumor overgrowth and sludge formation did not signifi cantly differ between the two groups, whereas the rate of tumor ingrowth was signifi cantly lower in the covered than in the uncovered SEMS group ( P < 0.01).There was no signifi cant difference between the two groups in the incidence of serious adverse events.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-09-01
• Study Start: 2013-01-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

1) PS > 4. 2) Severe complication of another organ. 3) A patient who gives no written IC. 4) A participating doctor thinks the patient is not proper for this study. 5) Prognosis will be within 3 months. 6) Initial drainage worsen the status of the patient.

Study & Design

• Study Type: Interventional
• Study Design: Not specified