Effects of Intraarterial Octreotide on Pancreatic Texture

March 4, 2012 updated by: Orlin Belyaev, St. Josef Hospital Bochum

Changes in Pancreatic Texture After Single-shot Administration of 500 µg Octreotide in the Gastroduodenal Artery During Pancreatoduodenectomy - a Double-Blinded Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 theory is based on the results of a single animal experiment and a small case series in humans. This hardening effect of octreotide has not quantitatively been proven in humans and its mechanism is not clear. Histomorphologic correlates of pancreatic hardness are unknown.

In this study all patients who are eligible for pancreatoduodenectomy and sign the informed consent for participation in the study will be recruited. Those of them who prove to have a soft pancreas intraoperatively will receive a single bolus of 500 µg Octreotide in the gastroduodenal artery after its proximal division. Pancreatic hardness in the region of the resection margin will be quantitatively assessed by a Shore durometer before the intervention and at several time-points after it. The suture-holding capacity of pancreatic tissue at the resection margin will be quantitatively assessed by a dynamometer. Histomorphological features of pancreatic tissue will be characterized in details at the Institute of Pathology in order to define possible correlates of pancreatic hardness.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44791
        • Department of Surgery, St. Josef Hospital, Ruhr University of Bochum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Octreotide
Study patients receive after randomization a single shot of 5 mL 500 µg Octreotide in the gastroduodenal artery at the time of its transection.
Drug: Intraarterial application of Octreotide
500 µg / 5 ml Octreotide is given as a single bolus injection in the gastroduodenal artery intraoperatively.
Other Names:
  • Siroctid
  • Sandostatin (Novartis Pharma, Switzerland)
  • Bendatreotid
  • Octreo
  • Octreotid
PLACEBO_COMPARATOR: Control
Control patients receive after randomization a single shot of 5 mL 0,9% NaCL solution in the gastroduodenal artery at the time of its transection.
Drug: sterile NaCl (sodium chloride) 0,9% solution
a single intraarterial shot of 5 ml saline solution in the gastroduodenal artery
Other Names:
  • Sodium chloride 0,9% solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatic hardness
Time Frame: 3 months postoperatively
Pancreatic hardness is a quantifiable parameter, measured by a Shore Durometer in Shore Units on a 0-100 SU scale.
3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of postoperative pancreatic fistula
Time Frame: 3 months postoperatively
Postoperative pancreatic fistula occurrs after pancreatoduodenectomy with an estimated rate of 5-30% depending on the definition used and a number of factors such as surgical technique, pancreatic texture, experience of the surgeon, hospital volume etc.
3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Josef Hospital Bochum

Investigators

  • Study Director: Orlin Belyaev, MD, Department of Surgery, St. Josef Hospital
  • Principal Investigator: Christian Polle, Ruhr University of Bochum
  • Study Chair: Waldemar Uhl, MD, PhD, Department of Surgery, St. Josef Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

July 7, 2011

First Submitted That Met QC Criteria

July 21, 2011

First Posted (ESTIMATE)

July 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2012

Last Update Submitted That Met QC Criteria

March 4, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4033-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Fistula

Clinical Trials on Intraarterial application of Octreotide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe