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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

July 7, 2011
March 4, 2012
August 2011
February 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01400100 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effects of Intraarterial Octreotide on Pancreatic Texture
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Pancreatic Fistula
  • 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
  • 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
  • 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.
    Intervention: Drug: Intraarterial application of Octreotide
  • 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.
    Intervention: Drug: sterile NaCl (sodium chloride) 0,9% solution

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
March 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01400100
4033-11
Yes
Orlin Belyaev, St. Josef Hospital Bochum
St. Josef Hospital Bochum
Not Provided
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
St. Josef Hospital Bochum
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP