Effects of Intraarterial Octreotide on Pancreatic Texture

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pancreatic Fistula

Intervention / Treatment
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* Drug: Intraarterial application of Octreotide
* Drug: sterile NaCl (sodium chloride) 0,9% solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Octreotide<br>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<br>* 500 µg / 5 ml Octreotide is given as a single bolus injection in the gastroduodenal artery intraoperatively.<br>* Other names: Octreotid;|
| Placebo Comparator: Control<br>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<br>* a single intraarterial shot of 5 ml saline solution in the gastroduodenal artery<br>* Other names: Sodium chloride 0,9% solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic hardness | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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octreotide, intraarterial, pancreatic hardness, pancreatoduodenectomy, durometer, dynamometer