Effects of Intraarterial Octreotide on Pancreatic Texture

Pancreatic Fistula Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400100
• Other study ID #: 4033-11
• Status: Completed
• Phase: N/A
• First received: July 7, 2011
• Last updated: March 4, 2012
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: St. Josef Hospital Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pancreatic Fistula

Intervention

Drug:
• Intraarterial application of Octreotide
500 µg / 5 ml Octreotide is given as a single bolus injection in the gastroduodenal artery intraoperatively.
• sterile NaCl (sodium chloride) 0,9% solution
a single intraarterial shot of 5 ml saline solution in the gastroduodenal artery

Locations

Country	Name	City	State
Germany	Department of Surgery, St. Josef Hospital, Ruhr University of Bochum	Bochum	NRW

Sponsors (1)

Lead Sponsor	Collaborator
St. Josef Hospital Bochum

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. Epub . — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Rate of postoperative pancreatic fistula	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.	3 months postoperatively	No