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

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00500968
First received: July 12, 2007
Last updated: April 6, 2011
Last verified: September 2007
  Purpose

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


Condition Intervention
Pancreas Cancer
Fistula
Procedure: stent
Procedure: Distal pancreatectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Drain fluid content analyses [ Time Frame: At least 5 postoperative days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: At least 5 postoperative days ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: November 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stent Procedure: stent
ERCP guided stent insertion before transection of the gland
Other Name: ERCP
Active Comparator: conventional distal pancreatectomy Procedure: Distal pancreatectomy
conventional distal pancreatectomy
Other Name: surgery

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00500968

Locations
Sweden
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
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karoliska instuitut, Farshad Frozanpor
ClinicalTrials.gov Identifier: NCT00500968     History of Changes
Other Study ID Numbers: 2006/3:3
Study First Received: July 12, 2007
Last Updated: April 6, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Pancreas
Leakage
Fistula
tail

Additional relevant MeSH terms:
Fistula
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 21, 2014