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Preoperative Stent Study

Primary Purpose

Pancreas Cancer

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Plastic and metalic stent inserion
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring Pancreas, cancer, SEMS, Plastic, stent, Whipple, Jaundicie

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The primary inclusion criteria are all patients with operable Periampullary cancer and jaundice who have not previously undergone bile flow drainage.

Exclusion Criteria:

  • Define as failed ERCP, patients who have previously undergone bile flow drainage or radical surgery is not possible.

Sites / Locations

  • Karolinksa University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

plastic stent

metalic stent

Arm Description

Stent insertion

Stent inserttion

Outcomes

Primary Outcome Measures

Intra-operative measurement of the Culture from the bile.

Secondary Outcome Measures

Intraoperative measurements of inflammatory reaction in the liver, hepatoduodenal ligament and around the bile ducts with biopsies. Stent dysfunction and cholangitis after ERCP and pre-operative bile flow relief. Postoperative analysis.

Full Information

First Posted
July 11, 2007
Last Updated
June 22, 2022
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT00501176
Brief Title
Preoperative Stent Study
Official Title
Randomized Study Comparing the Effect of Plastic Stents to That of Expandable Metal Stents Prior to Pancreaticoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized study comparing the effect of plastic stents to that of expandable metal stents as pre-operative drainage of the bile ducts prior to Whipple operation.
Detailed Description
Patients suffering from a locally invasive tumour process in the Periampullary area usually seek medical attention because of jaundice. Not only do patients suffering from jaundice show significant symptoms of exhaustion and purities, but they are also at higher risk for developing post-operative complications. Experimentally, the liver exhibits a reduced capacity for tolerating ischemia in the presence of jaundice. Several different etiologic factors suggest cause complication such as presence of toxic substances as bilirubin and bile salts, impaired nutritional status, effects of endotoxins, bacterial translocation, modulation of the inflammatory cascade with cytokine release, reduction of cellular immunity and nutritional. These complications primarily consist of septic complications (cholangitis, abscesses, and leakage), haemorrhage, impaired wound healing and renal disorders. Summarily, these issues have motivated pre-operative bile flow drainage by way of stent. Traditionally, pre-operative bile flow drainage has been achieved by insertion of a EP because these are considered easy to remove and cause less tissue reaction in the bile ducts. However, multiple studies have found the disadvantage with the EP is that it provides poorer bile drainage than the SEMS. In palliative situations, metal stents have been associated with fewer side-effects in the form of fever relapse of jaundice, etc. These effects are likely due to better bile flow through the stent. It remains unclear if metal stents can provide similar advantages in the curative situation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer
Keywords
Pancreas, cancer, SEMS, Plastic, stent, Whipple, Jaundicie

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
plastic stent
Arm Type
Active Comparator
Arm Description
Stent insertion
Arm Title
metalic stent
Arm Type
Active Comparator
Arm Description
Stent inserttion
Intervention Type
Procedure
Intervention Name(s)
Plastic and metalic stent inserion
Other Intervention Name(s)
Two types of Stent prior to Whipple procedure
Intervention Description
Patient randomizes to metal or plastic insertion prior to Whipple procedure
Primary Outcome Measure Information:
Title
Intra-operative measurement of the Culture from the bile.
Time Frame
Intraoperativt
Secondary Outcome Measure Information:
Title
Intraoperative measurements of inflammatory reaction in the liver, hepatoduodenal ligament and around the bile ducts with biopsies. Stent dysfunction and cholangitis after ERCP and pre-operative bile flow relief. Postoperative analysis.
Time Frame
Perioperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The primary inclusion criteria are all patients with operable Periampullary cancer and jaundice who have not previously undergone bile flow drainage. Exclusion Criteria: Define as failed ERCP, patients who have previously undergone bile flow drainage or radical surgery is not possible.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Enochsson, MD, PhD
Organizational Affiliation
Karolinksa Institutet
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Urban Arnelo, M.D.
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lars Lundell, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
Facility Information:
Facility Name
Karolinksa University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

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Preoperative Stent Study

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