CompletedNot Applicable

Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage

South Korea86 participantsStarted 2012-01

Plain-language summary

This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.

Who can participate

Age range20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Older than 20 years old of age * Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary cancer * No evidence of distant metastases or locally advanced tumor Exclusion Criteria: * Unresectable stage of cancer * Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal gastrectomy with B-II anastomosis) * Severe gastric outlet obstruction or duodenal obstruction * Severe comorbidity (Karnofsky\<50%)

What they're measuring

Adverse events related to the stent insertion

Timeframe: up to 4weeks

Trial details

NCT IDNCT01789502

SponsorInje University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

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