Pancreatic Fistula Clinical Trial
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
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science
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