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

Pancreas Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500968
• Other study ID #: 2006/3:3
• Status: Completed
• Phase: N/A
• First received: July 12, 2007
• Last updated: April 6, 2011
• Start date: November 2006
• Est. completion date: April 2011

Study information

• Verified date: September 2007
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• stent
ERCP guided stent insertion before transection of the gland
• Distal pancreatectomy
conventional distal pancreatectomy

Locations

Country	Name	City	State
Sweden	Karolinksa university hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drain fluid content analyses	Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.	At least 5 postoperative days	Yes
Secondary	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	Yes