Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail - Full Text View

Sponsor:	Karolinska Institutet
Information provided by:	Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT00500968

Purpose

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

Condition	Intervention
Pancreas Cancer Fistula	Procedure: Left sided pancreatic resection

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fistulas Pancreatic Cancer

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:

Post-operativt daily measurement of pancreatic enzyme content in the drain fluid. X-Amylase and X-Protein as long as the patient has the external drain. [ Time Frame: daily ]

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: Hospitalisation time ]

Estimated Enrollment:	50
Study Start Date:	November 2006
Estimated Study Completion Date:	March 2009

Detailed Description:

Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13,2-64% [30], 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. Daily measurement of pancreatic enzyme content in the drain fluid. 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 and cost. 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500968

Contacts

Contact: Farshad Frozanpor		farshad.frozanpor@sodersjukhuset.se
Contact: Urban Arnelo		Urban.Arnelo@ki.se

Locations

Sweden
Karolinksa university hospital	Recruiting
Stockholm, Sweden, 14186
Contact: Farshad Frozanpor
Contact: Urban Arnelo

Sponsors and Collaborators

Karolinska Institutet

Investigators

Principal Investigator:

Urban Arnelo

Karolinksa university hospital

More Information

No publications provided

Study ID Numbers:	2006/3:3
Study First Received:	July 12, 2007
Last Updated:	July 16, 2007
ClinicalTrials.gov Identifier:	NCT00500968 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:

Pancreas
Leackage
Fistula
tail

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Endocrine Gland Neoplasms
Fistula

ClinicalTrials.gov processed this record on February 04, 2010