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Effects of Intraarterial Octreotide on Pancreatic Texture

NCT01400100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2012-03-06

No results posted yet for this study

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 with soft pancreatic tissue hardens the texture of the pancreatic remnant.

A primary end-point of the study is a change in pancreatic texture.

A secondary end-point is the rate of postoperative pancreatic fistula.

Conditions

  • Pancreatic Fistula

Interventions

DRUG

Intraarterial application of Octreotide

500 µg / 5 ml Octreotide is given as a single bolus injection in the gastroduodenal artery intraoperatively.

DRUG

sterile NaCl (sodium chloride) 0,9% solution

a single intraarterial shot of 5 ml saline solution in the gastroduodenal artery

Sponsors & Collaborators

  • St. Josef Hospital Bochum

    lead OTHER

Principal Investigators

  • Orlin Belyaev, MD · Department of Surgery, St. Josef Hospital

  • Christian Polle · Ruhr University of Bochum

  • Waldemar Uhl, MD, PhD · Department of Surgery, St. Josef Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400100 on ClinicalTrials.gov