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

Not Applicable

Completed

• Conditions: Pancreas Cancer; Fistula
• Interventions: Procedure: stent; Procedure: Distal pancreatectomy

• Registration Number: NCT00500968
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-07-12
• Study First Submitted QC: 2007-07-12
• Study First Posted: 2007-07-13
• Status Verified: 2007-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Last Update Submitted: 2011-04-06
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stent	stent	-
conventional distal pancreatectomy	Distal pancreatectomy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Karolinksa university hospital; 🇸🇪 Stockholm, Sweden