Effects of Intraarterial Octreotide on Pancreatic Texture

St. Josef Hospital Bochum

Status: Completed

Conditions: Pancreatic Fistula

Treatments: Drug: Intraarterial application of Octreotide; Drug: sterile NaCl (sodium chloride) 0,9% solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01400100

4033-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

Octreotide

Experimental group

Description:

Study patients receive after randomization a single shot of 5 mL 500 µg Octreotide in the gastroduodenal artery at the time of its transection.

Treatment:

Drug: Intraarterial application of Octreotide

Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: sterile NaCl (sodium chloride) 0,9% solution