NCT03350763

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

November 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

8 years

First QC Date

November 18, 2017

Last Update Submit

May 18, 2021

Conditions

Pancreatic Cancer

Keywords

Pancreatic CancerBiliary decompression

Outcome Measures

Primary Outcomes (1)

  • Stent failure rate, and need for re-procedure before pancreaticoduodenectomy.

    Evaluation at the day of pancreatic surgery

Secondary Outcomes (1)

  • Other complications related to preoperative biliary decompression, and post-surgical complications

    Complication emerged within 120 days from pancreaticoduodenectomy

Study Arms (2)

Plastic biliary stent

EXPERIMENTAL

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

Device: Tannenbaum 10 Fr biliary stent

Self-expandable metallic biliary stent

EXPERIMENTAL

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

Device: Self-expandable metallic biliary stent

Interventions

Tannenbaum 10 Fr biliary stentDEVICE

Tannenbaum 10 Fr biliary stent

Plastic biliary stent
Self-expandable metallic biliary stentDEVICE

ie WallFlex biliary RX

Self-expandable metallic biliary stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Related Publications (3)

  • 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.

    PMID: 21373939BACKGROUND

  • 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.

    PMID: 25028410BACKGROUND

  • 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.

    PMID: 19129611BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Leena Kylänpää, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of department

Study Record Dates

First Submitted

November 18, 2017

First Posted

November 22, 2017

Study Start

November 18, 2017

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)