Effects of Intraarterial Octreotide on Pancreatic Texture

NCT ID: NCT01400100

Last Updated: 2012-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-03-31

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.

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.

Conditions

Pancreatic Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intraarterial application of Octreotide

Intervention Type: DRUG

500 µg / 5 ml Octreotide is given as a single bolus injection in the gastroduodenal artery intraoperatively.

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.

Group Type: PLACEBO_COMPARATOR

sterile NaCl (sodium chloride) 0,9% solution

Intervention Type: DRUG

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

Interventions

Intraarterial application of Octreotide

500 µg / 5 ml Octreotide is given as a single bolus injection in the gastroduodenal artery intraoperatively.

Intervention Type: DRUG

sterile NaCl (sodium chloride) 0,9% solution

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

Intervention Type: DRUG

Other Intervention Names

Sandostatin (Novartis Pharma, Switzerland); Bendatreotid; Octreo; Siroctid; Octreotid; Sodium chloride 0,9% solution

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Josef Hospital Bochum

OTHER

Sponsor Role: lead

Responsible Party

Orlin Belyaev

Dr. med. Orlin Belyaev

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Orlin Belyaev, MD

Role: STUDY_DIRECTOR

Department of Surgery, St. Josef Hospital

Christian Polle

Role: PRINCIPAL_INVESTIGATOR

Ruhr University of Bochum

Waldemar Uhl, MD, PhD

Role: STUDY_CHAIR

Department of Surgery, St. Josef Hospital

Locations

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

Bochum, North Rhine-Westphalia, Germany

Countries

Germany

References

Foitzik T, Gock M, Schramm C, Prall F, Klar E. Octreotide hardens the pancreas. Langenbecks Arch Surg. 2006 Apr;391(2):108-12. doi: 10.1007/s00423-006-0030-z. Epub 2006 Mar 28.

Reference Type: BACKGROUND

PMID: 16568326 (View on PubMed)

Konstadoulakis MM, Filippakis GM, Lagoudianakis E, Antonakis PT, Dervenis C, Bramis J. Intra-arterial bolus octreotide administration during Whipple procedure in patients with fragile pancreas: a novel technique for safer pancreaticojejunostomy. J Surg Oncol. 2005 Mar 15;89(4):268-72. doi: 10.1002/jso.20193.

Reference Type: BACKGROUND

PMID: 15726611 (View on PubMed)

Belyaev O, Herden H, Meier JJ, Muller CA, Seelig MH, Herzog T, Tannapfel A, Schmidt WE, Uhl W. Assessment of pancreatic hardness-surgeon versus durometer. J Surg Res. 2010 Jan;158(1):53-60. doi: 10.1016/j.jss.2008.08.022.

Reference Type: BACKGROUND

PMID: 19394646 (View on PubMed)

Belyaev O, Polle C, Herzog T, Munding J, Chromik AM, Meurer K, Tannapfel A, Bergmann U, Muller CA, Uhl W. Effects of intra-arterial octreotide on pancreatic texture: a randomized controlled trial. Scand J Surg. 2013;102(3):164-70. doi: 10.1177/1457496913490457.

Reference Type: DERIVED

PMID: 23963030 (View on PubMed)

Other Identifiers

4033-11

Identifier Type: -

Identifier Source: org_study_id