Effects of Intraarterial Octreotide on Pancreatic Texture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orlin Belyaev, St. Josef Hospital Bochum
ClinicalTrials.gov Identifier:
NCT01400100
First received: July 7, 2011
Last updated: March 4, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Pancreatic Fistula
Drug: Intraarterial application of Octreotide
Drug: sterile NaCl (sodium chloride) 0,9% solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Changes in Pancreatic Texture After Single-shot Administration of 500 µg Octreotide in the Gastroduodenal Artery During Pancreatoduodenectomy - a Double-Blinded Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by St. Josef Hospital Bochum:

Primary Outcome Measures:
  • Pancreatic hardness [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    Pancreatic hardness is a quantifiable parameter, measured by a Shore Durometer in Shore Units on a 0-100 SU scale.


Secondary Outcome Measures:
  • Rate of postoperative pancreatic fistula [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Sandostatin (Novartis Pharma, Switzerland)
  • Bendatreotid
  • Octreo
  • Siroctid
  • 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 Name: Sodium chloride 0,9% solution

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400100

Locations
Germany
Department of Surgery, St. Josef Hospital, Ruhr University of Bochum
Bochum, NRW, Germany, 44791
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Orlin Belyaev, Dr. med. Orlin Belyaev, St. Josef Hospital Bochum
ClinicalTrials.gov Identifier: NCT01400100     History of Changes
Other Study ID Numbers: 4033-11
Study First Received: July 7, 2011
Last Updated: March 4, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by St. Josef Hospital Bochum:
octreotide
intraarterial
pancreatic hardness
pancreatoduodenectomy
durometer
dynamometer

Additional relevant MeSH terms:
Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 23, 2014