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

Primary Purpose

Pancreatic Cancer

Status

Withdrawn

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Tannenbaum 10 Fr biliary stent

Self-expandable metallic biliary stent

Sponsored by

Helsinki University Central Hospital

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Biliary decompression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Plastic biliary stent

Self-expandable metallic biliary stent

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

First Posted

November 18, 2017

Last Updated

May 18, 2021

Sponsor

Helsinki University Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03350763

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Investigators busy with other projects at the moment

Study Start Date

November 18, 2017 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Pancreatic Cancer, Biliary decompression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Plastic biliary stent

Arm Type

Experimental

Arm Description

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

Arm Title

Self-expandable metallic biliary stent

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Tannenbaum 10 Fr biliary stent

Intervention Description

Tannenbaum 10 Fr biliary stent

Intervention Type

Device

Intervention Name(s)

Self-expandable metallic biliary stent

Intervention Description

ie WallFlex biliary RX

Primary Outcome Measure Information:

Title

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

Time Frame

Evaluation at the day of pancreatic surgery

Secondary Outcome Measure Information:

Title

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

Time Frame

Complication emerged within 120 days from pancreaticoduodenectomy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leena Kylänpää, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helsinki University Hospital

City

Helsinki

State/Province

Uusimaa

ZIP/Postal Code

00029

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

21373939

Citation

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.

Results Reference

background

PubMed Identifier

25028410

Citation

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.

Results Reference

background

PubMed Identifier

19129611

Citation

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.

Results Reference

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

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