Comparison of metal versus plastic side-by-side stent insertion in malignant hilar biliary obstructio

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0004824
• Lead Sponsor: Seoul National University Hospital

Brief Summary

: Both groups had 100% technical success rates; 88% and 76% of clinical success rates were obtained in MS and PS, respectively. Although stent migrations were more frequent in MS than PS (48% vs. 16%, P = 0.02), the mean TRBO was significantly longer in MS (190 days; 95% confidence interval [CI] 121–260 days vs. 96 days; 95% CI 50–141 days, P = 0.02). The placement of plastic stents (hazard ratio 2.42; 95% CI 1.24–4.73; P = 0.01) was the only significant risk factor associated with TRBO in multivariable analysis. The rates of adverse events were similar between the two groups (difference 0%; 95% CI 25% to 25%; P > 0.99)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-31
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Unresectable malignant hilar biliary stricture requiring biliary drainage through endoscopic procedure

Exclusion Criteria

If endoscopy is not possible based on the judgement of the researcher
Life expectancy less than 6 months
Acute cholecystitis
Previous history of percutaneous transhepatic biliary drainage
Previous history of metal stent placement for malignant biliary stricture

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of the stent patency

Secondary Outcome Measures

Name	Time	Method
Technical success, clinical success;Stent malfunction rate;Reintervention rate and cause of reintervention;Adverse event related to the procedure;Success rate of the stent removal