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

NCT ID: NCT00500968

Last Updated: 2011-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Pancreas Cancer Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stent

Group Type ACTIVE_COMPARATOR

stent

Intervention Type PROCEDURE

ERCP guided stent insertion before transection of the gland

conventional distal pancreatectomy

Group Type ACTIVE_COMPARATOR

Distal pancreatectomy

Intervention Type PROCEDURE

conventional distal pancreatectomy

Interventions

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stent

ERCP guided stent insertion before transection of the gland

Intervention Type PROCEDURE

Distal pancreatectomy

conventional distal pancreatectomy

Intervention Type PROCEDURE

Other Intervention Names

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ERCP surgery

Eligibility Criteria

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Exclusion Criteria

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

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Farshad Frozanpor

Principal Investigators

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Urban Arnelo

Role: STUDY_DIRECTOR

Karolinksa university hospital

Farshad Frozanpor

Role: PRINCIPAL_INVESTIGATOR

Karolinksa university hospital

Lars Lundell, Professor

Role: STUDY_CHAIR

Karolinska Institutet

Locations

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Karolinksa university hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 22584629 (View on PubMed)

Other Identifiers

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2006/3:3

Identifier Type: -

Identifier Source: org_study_id

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