Back to resultsPancreatic Stump Closure After Distal Pancreatic Resection
Primary Purpose
Distal Pancreatic Resections
Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
pancreatico-jejunal anastomosis
traditional anastomosis
Sponsored by
About this trial
This is an interventional prevention trial for Distal Pancreatic Resections focused on measuring pancreas, pancreatico-jejunal anastomosis, postoperative pancreatic fistulae
Eligibility Criteria
Inclusion Criteria:
- patiens which the distal pancreatic resektions
- the type of resections that is techically possible with finnish binding panceatico-jejunal anastomosis
Exclusion Criteria:
- if the pancreas is not suitable for this kind of anastomosis
Sites / Locations
- Tampere University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
pancreatico-jejunal anastomosis
traditional anastomosis
Arm Description
patients in which the finnish binding pancreatico-jejunal anastomosis is techically possible to perfom during distal pancreatic resektion
pancreatic resections with traditional stump closure
Outcomes
Primary Outcome Measures
postoperative pancreatic fistula rata
Secondary Outcome Measures
Number of patients with resection margin on the left side of portal vein as a measure of feasibility.
Full Information
NCT ID
NCT02113046
First Posted
March 26, 2014
Last Updated
April 9, 2014
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02113046
Brief Title
Pancreatic Stump Closure After Distal Pancreatic Resection
Official Title
Prospective Randomized Study to Decrease Pancreatic Fistula Rate
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
interim analysis does not show good results
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to investigate whether finnish binding pancreatico-jejunal anastomosis is feasible and prevents the risk for post operative pancreatic fistula after distal pancreeatectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Pancreatic Resections
Keywords
pancreas, pancreatico-jejunal anastomosis, postoperative pancreatic fistulae
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pancreatico-jejunal anastomosis
Arm Type
Active Comparator
Arm Description
patients in which the finnish binding pancreatico-jejunal anastomosis is techically possible to perfom during distal pancreatic resektion
Arm Title
traditional anastomosis
Arm Type
Active Comparator
Arm Description
pancreatic resections with traditional stump closure
Intervention Type
Procedure
Intervention Name(s)
pancreatico-jejunal anastomosis
Intervention Type
Procedure
Intervention Name(s)
traditional anastomosis
Primary Outcome Measure Information:
Title
postoperative pancreatic fistula rata
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of patients with resection margin on the left side of portal vein as a measure of feasibility.
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patiens which the distal pancreatic resektions
the type of resections that is techically possible with finnish binding panceatico-jejunal anastomosis
Exclusion Criteria:
if the pancreas is not suitable for this kind of anastomosis
Facility Information:
Facility Name
Tampere University hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Pancreatic Stump Closure After Distal Pancreatic Resection
We'll reach out to this number within 24 hrs