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

Helsinki University Central Hospital (HUCH)

Status: Withdrawn

Conditions: Pancreatic Cancer

Treatments: Device: Tannenbaum 10 Fr biliary stent; Device: Self-expandable metallic biliary stent

Study type: Interventional

Funder types: Other

Identifiers

NCT03350763

HUS/2470/2017

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Plastic biliary stent

Experimental group

Description:

A plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression

Treatment:

Device: Tannenbaum 10 Fr biliary stent

Self-expandable metallic biliary stent

Experimental group

Description:

A self-expandable metallic biliary stent is used to achieve biliary decompression

Treatment:

Device: Self-expandable metallic biliary stent