Effects of Intraarterial Octreotide on Pancreatic Texture

NCT01400100 | Completed DMC

• 1 other identifier: 4033-11
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Fistula

Keywords

octreotide; intraarterial; pancreatic hardness; pancreatoduodenectomy; durometer; dynamometer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of postoperative pancreatic fistula

  3 months postoperatively

Study Arms (2)

Octreotide

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Intraarterial application of Octreotide DRUG

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

Also known as: Sandostatin (Novartis Pharma, Switzerland), Bendatreotid, Octreo, Siroctid, Octreotid

Octreotide

sterile NaCl (sodium chloride) 0,9% solution DRUG

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

Also known as: Sodium chloride 0,9% solution

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Josef Hospital Bochum: lead

Study Sites (1)

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

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Related Publications (4)

• 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.

  PMID: 16568326 BACKGROUND

• 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.

  PMID: 15726611 BACKGROUND

• 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.

  PMID: 19394646 BACKGROUND

• 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.

  PMID: 23963030 DERIVED

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Octreotide; Sodium Chloride

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Orlin Belyaev, MD

  Department of Surgery, St. Josef Hospital

  STUDY DIRECTOR

• Christian Polle

  Ruhr University of Bochum

  PRINCIPAL INVESTIGATOR

• Waldemar Uhl, MD, PhD

  Department of Surgery, St. Josef Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Orlin Belyaev

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 22, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

DE (1)