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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00500968
Enrollment
50
Registered
2007-07-13
Start date
2006-11-30
Completion date
2011-04-30
Last updated
2011-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fistula, Pancreas Cancer

Keywords

Pancreas, Leakage, Fistula, tail

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.

Interventions

PROCEDUREstent

ERCP guided stent insertion before transection of the gland

PROCEDUREDistal pancreatectomy

conventional distal pancreatectomy

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Drain fluid content analysesAt least 5 postoperative daysPost-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.

Secondary

MeasureTime frame
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 stentAt least 5 postoperative days

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026