Clinical trial NCT01400100: Effects of Intraarterial Octreotide on Pancreatic Texture
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Fistula
Keywords: octreotide
intraarterial
pancreatic hardness
pancreatoduodenectomy
durometer
dynamometer
Lead sponsor: St. Josef Hospital Bochum
Sponsor class: OTHER
First posted: 2011-07-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Pancreatic hardness
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Rate of postoperative pancreatic fistula
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Surgery, St. Josef Hospital, Ruhr University of Bochum
state: NRW
Study officials:
affiliation: Department of Surgery, St. Josef Hospital
name: Orlin Belyaev, MD
role: STUDY_DIRECTOR
affiliation: Ruhr University of Bochum
name: Christian Polle
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, St. Josef Hospital
name: Waldemar Uhl, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.