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Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

Primary Purpose

Pancreas Cancer, Fistula

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
stent
Distal pancreatectomy
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, Leakage, Fistula, tail

Eligibility Criteria

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

Inclusion Criteria:

  • Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate.

Exclusion Criteria:

  • The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.

Sites / Locations

  • Karolinksa university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Stent

conventional distal pancreatectomy

Arm Description

Outcomes

Primary Outcome Measures

Drain fluid content analyses
Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.

Secondary Outcome Measures

Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization and cost. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent

Full Information

First Posted
July 12, 2007
Last Updated
April 6, 2011
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT00500968
Brief Title
Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
Official Title
Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.
Detailed Description
Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface. Trial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain. B. Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Fistula
Keywords
Pancreas, Leakage, Fistula, tail

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Stent
Arm Type
Active Comparator
Arm Title
conventional distal pancreatectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
stent
Other Intervention Name(s)
ERCP
Intervention Description
ERCP guided stent insertion before transection of the gland
Intervention Type
Procedure
Intervention Name(s)
Distal pancreatectomy
Other Intervention Name(s)
surgery
Intervention Description
conventional distal pancreatectomy
Primary Outcome Measure Information:
Title
Drain fluid content analyses
Description
Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.
Time Frame
At least 5 postoperative days
Secondary Outcome Measure Information:
Title
Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization and cost. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent
Time Frame
At least 5 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate. Exclusion Criteria: The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urban Arnelo
Organizational Affiliation
Karolinksa university hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Farshad Frozanpor
Organizational Affiliation
Karolinksa university hospital
Official's Role
Principal Investigator
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

Citations:
PubMed Identifier
22584629
Citation
Frozanpor F, Lundell L, Segersvard R, Arnelo U. The effect of prophylactic transpapillary pancreatic stent insertion on clinically significant leak rate following distal pancreatectomy: results of a prospective controlled clinical trial. Ann Surg. 2012 Jun;255(6):1032-6. doi: 10.1097/SLA.0b013e318251610f.
Results Reference
derived

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Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

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