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NCT Number: NCT01400100

Effects of Intraarterial Octreotide on Pancreatic Texture

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.

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Key information

Conditions

Pancreatic Fistula Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, St. Josef Hospital, Ruhr University of Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraarterial application of Octreotide

Drug

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

sterile NaCl (sodium chloride) 0,9% solution

Drug

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

Other names: Sodium chloride 0,9% solution

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

St. Josef Hospital Bochum

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 22, 2011
Registry last updated
Mar 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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