Effects of Intraarterial Octreotide on Pancreatic Texture

Sponsor

St. Josef Hospital Bochum (Other)

Overall Status

Completed

CT.gov ID

NCT01400100

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Fistula	Drug: Intraarterial application of Octreotide Drug: sterile NaCl (sodium chloride) 0,9% solution	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Basic Science

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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.	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
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.	Drug: sterile NaCl (sodium chloride) 0,9% solution a single intraarterial shot of 5 ml saline solution in the gastroduodenal artery Other Names: Sodium chloride 0,9% solution

Arm

Intervention/Treatment

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.

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

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.

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

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

Other Names:

Sodium chloride 0,9% solution

Outcome Measures

Primary Outcome Measures

Pancreatic hardness [3 months postoperatively]
Pancreatic hardness is a quantifiable parameter, measured by a Shore Durometer in Shore Units on a 0-100 SU scale.

Secondary Outcome Measures

Rate of postoperative pancreatic fistula [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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