Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?

Not Applicable

Withdrawn

• Conditions: Pancreatic Cancer
• Interventions: Device: Tannenbaum 10 Fr biliary stent; Device: Self-expandable metallic biliary stent

• Registration Number: NCT03350763
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded.

This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-18
• Study First Submitted: 2017-11-18
• Study First Submitted QC: 2017-11-18
• Study First Posted: 2017-11-22
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Resectable tumor of the head of the pancreas
• Elevated serum bilirubin levels
• Radiologically visible dilatation of the biliary system

Exclusion Criteria

• Distant metastasis
• Inoperable tumor or other reason, why the patient is unfit for surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plastic biliary stent	Tannenbaum 10 Fr biliary stent	A plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression
Self-expandable metallic biliary stent	Self-expandable metallic biliary stent	A self-expandable metallic biliary stent is used to achieve biliary decompression

Primary Outcome Measures

Name	Time	Method
Stent failure rate, and need for re-procedure before pancreaticoduodenectomy.	Evaluation at the day of pancreatic surgery

Secondary Outcome Measures

Name	Time	Method
Other complications related to preoperative biliary decompression, and post-surgical complications	Complication emerged within 120 days from pancreaticoduodenectomy

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Uusimaa, Finland