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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00500968
First Posted: July 13, 2007
Last Update Posted: April 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Karolinska Institutet
  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
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

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 ]
    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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: July 12, 2007
First Posted: July 13, 2007
Last Update Posted: April 7, 2011
Last Verified: September 2007

Keywords provided by Karolinska Institutet:
Pancreas
Leakage
Fistula
tail

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