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

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT00500968
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
53
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.

Condition or Disease Intervention/Treatment Phase
  • Procedure: stent
  • Procedure: Distal pancreatectomy
 N/A

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.

  1. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
Study Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Stent

Procedure: stent
ERCP guided stent insertion before transection of the gland
Other Names:
  • ERCP

    		•
    Active Comparator: conventional distal pancreatectomy

    Procedure: Distal pancreatectomy
    conventional distal pancreatectomy
    Other Names:
  • surgery

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Drain fluid content analyses [At least 5 postoperative days]

      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

    1. 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 [At least 5 postoperative days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karolinksa university hospital Stockholm Sweden 14186

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

    • Study Director: Urban Arnelo, Karolinksa university hospital
    • Principal Investigator: Farshad Frozanpor, Karolinksa university hospital
    • Study Chair: Lars Lundell, Professor, Karolinska Institutet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00500968
    Other Study ID Numbers:
    • 2006/3:3
    First Posted:
    Jul 13, 2007
    Last Update Posted:
    Apr 7, 2011
    Last Verified:
    Sep 1, 2007
    Keywords provided by , ,
    Pancreas
    Leakage
    Fistula
    tail
    Additional relevant MeSH terms:
    Pancreatic Neoplasms
    Fistula

    Study Results

    No Results Posted as of Apr 7, 2011