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

Study Overview

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

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.

N/A

Pancreatic Cancer

DEVICE: Tannenbaum 10 Fr biliary stent
DEVICE: Self-expandable metallic biliary stent

HUS/2470/2017

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-11-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-05-18
First Submitted that Met QC Criteria 2017-11-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-05-19
First Posted (ACTUAL) 2017-11-22	Results First Posted N/A	Last Verified 2021-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Plastic biliary stent A plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression	DEVICE: Tannenbaum 10 Fr biliary stent Tannenbaum 10 Fr biliary stent
EXPERIMENTAL: Self-expandable metallic biliary stent A self-expandable metallic biliary stent is used to achieve biliary decompression	DEVICE: Self-expandable metallic biliary stent ie WallFlex biliary RX

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Plastic biliary stent

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

DEVICE: Tannenbaum 10 Fr biliary stent

Tannenbaum 10 Fr biliary stent

EXPERIMENTAL: Self-expandable metallic biliary stent

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

DEVICE: Self-expandable metallic biliary stent

ie WallFlex biliary RX

Primary Outcome Measures	Measure Description	Time Frame
Stent failure rate, and need for re-procedure before pancreaticoduodenectomy.		Evaluation at the day of pancreatic surgery

Secondary Outcome Measures	Measure Description	Time Frame
Other complications related to preoperative biliary decompression, and post-surgical complications		Complication emerged within 120 days from pancreaticoduodenectomy

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Leena Kylänpää, MD, PhD, Helsinki University Central Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Decker C, Christein JD, Phadnis MA, Wilcox CM, Varadarajulu S. Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer. Surg Endosc. 2011 Jul;25(7):2364-7. doi: 10.1007/s00464-010-1552-6. Epub 2011 Mar 4.
Haapamaki C, Seppanen H, Udd M, Juuti A, Halttunen J, Kiviluoto T, Siren J, Mustonen H, Kylanpaa L. Preoperative biliary decompression preceding pancreaticoduodenectomy with plastic or self-expandable metallic stent. Scand J Surg. 2015 Jun;104(2):79-85. doi: 10.1177/1457496914543975. Epub 2014 Jul 15.
Velanovich V, Kheibek T, Khan M. Relationship of postoperative complications from preoperative biliary stents after pancreaticoduodenectomy. A new cohort analysis and meta-analysis of modern studies. JOP. 2009 Jan 8;10(1):24-9.

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Clinical Trial Record