Back to results

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

Primary Purpose

Pancreas Cancer, Fistula

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

stent

Distal pancreatectomy

About this trial

This is an interventional treatment trial for Pancreas Cancer focused on measuring Pancreas, Leakage, Fistula, tail

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Karolinksa university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Stent

conventional distal pancreatectomy

Arm Description

Outcomes

Primary Outcome Measures

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.

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

Full Information

NCT ID

NCT00500968

First Posted

July 12, 2007

Last Updated

April 6, 2011

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT00500968

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreas Cancer, Fistula

Keywords

Pancreas, Leakage, Fistula, tail

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stent

Arm Type

Active Comparator

Arm Title

conventional distal pancreatectomy

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

stent

Other Intervention Name(s)

ERCP

Intervention Description

ERCP guided stent insertion before transection of the gland

Intervention Type

Procedure

Intervention Name(s)

Distal pancreatectomy

Other Intervention Name(s)

surgery

Intervention Description

conventional distal pancreatectomy

Primary Outcome Measure Information:

Title

Drain fluid content analyses

Description

Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.

Time Frame

At least 5 postoperative days

Secondary Outcome Measure Information:

Title

Time Frame

At least 5 postoperative days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Urban Arnelo

Organizational Affiliation

Karolinksa university hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Farshad Frozanpor

Organizational Affiliation

Karolinksa university hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lars Lundell, Professor

Organizational Affiliation

Karolinska Institutet

Official's Role

Study Chair

Facility Information:

Facility Name

Karolinksa university hospital

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

22584629

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs