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

Karolinska Institute logo

Karolinska Institute

Status

Completed

Conditions

Fistula
Pancreas Cancer

Treatments

Procedure: stent
Procedure: Distal pancreatectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT00500968
2006/3:3

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

20+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Stent
Active Comparator group
Treatment:
Procedure: stent
conventional distal pancreatectomy
Active Comparator group
Treatment:
Procedure: Distal pancreatectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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