Effects of Intraarterial Octreotide on Pancreatic Texture - Full Text View

Purpose

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	Intervention
Pancreatic Fistula	Drug: Intraarterial application of Octreotide Drug: sterile NaCl (sodium chloride) 0,9% solution

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) 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

Resource links provided by NLM:

MedlinePlus related topics: Fistulas

Drug Information available for: Sodium chloride Chlorine Octreotide acetate Octreotide

U.S. FDA Resources

Further study details as provided by St. Josef Hospital Bochum:

Primary Outcome Measures:

Pancreatic hardness [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
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 [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
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.

Enrollment:	26
Study Start Date:	August 2011
Study Completion Date:	March 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Sodium chloride 0,9% solution

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400100

Locations

Germany
Department of Surgery, St. Josef Hospital, Ruhr University of Bochum
Bochum, NRW, Germany, 44791

Sponsors and Collaborators

St. Josef Hospital Bochum

Investigators

Study Director:	Orlin Belyaev, MD	Department of Surgery, St. Josef Hospital
Principal Investigator:	Christian Polle	Ruhr University of Bochum
Study Chair:	Waldemar Uhl, MD, PhD	Department of Surgery, St. Josef Hospital

More Information

Publications:

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

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.

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.

Responsible Party:	Orlin Belyaev, Dr. med. Orlin Belyaev, St. Josef Hospital Bochum
ClinicalTrials.gov Identifier:	NCT01400100 History of Changes
Other Study ID Numbers:	4033-11
Study First Received:	July 7, 2011
Last Updated:	March 4, 2012
Health Authority:	Germany: Ethics Commission

Keywords provided by St. Josef Hospital Bochum:

octreotide
intraarterial
pancreatic hardness

pancreatoduodenectomy
durometer
dynamometer

Additional relevant MeSH terms:

Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases

Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013