Status:
COMPLETED
Effects of Intraarterial Octreotide on Pancreatic Texture
Lead Sponsor:
St. Josef Hospital Bochum
Conditions:
Pancreatic Fistula
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The aim of the study is to test the hypothesis that intraarterial bolus application of 500 µg Octreotide in the gastroduodenal artery during the resectional phase of pancreatoduodenectomy in patients ...
Detailed Description
Soft pancreas is an established risk factor for the development of postoperative pancreatic fistula in patients undergoing pancreatoduodenectomy. Octreotide is believed to harden the pancreas. This th...
Eligibility Criteria
Inclusion
- age between 18 an 90 years
- planned pancreatoduodenectomy
- signed informed consent
- pancreatic hardness equal or less than 40 SU as measured by durometer
- normal vascular anatomy of the hepato-pancreatic region
Exclusion
- planned distal pancreatic resection
- planned non-resectional pancreatic surgery
- acute pancreatitis at the time of surgery
- pancreatic hardness before intervention higher than 40 SU as measured by durometer
- intraoperatively unstable patient
- intraoperative complications
- allergy towards octreotide
- anatomical variation of the vascular supply of the liver or pancreas posing an increased risk for octreotide distribution in other organs than pancreas
- lacking gastroduodenal artery or technically impossible cannulation of the artery
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01400100
Start Date
August 1 2011
End Date
March 1 2012
Last Update
March 6 2012
Active Locations (1)
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1
Department of Surgery, St. Josef Hospital, Ruhr University of Bochum
Bochum, North Rhine-Westphalia, Germany, 44791