Effects of Intraarterial Octreotide on Pancreatic Texture
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.
|Pancreatic Fistula||Drug: Intraarterial application of Octreotide Drug: sterile NaCl (sodium chloride) 0,9% solution|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
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|
- Pancreatic hardness [ Time Frame: 3 months postoperatively ]Pancreatic hardness is a quantifiable parameter, measured by a Shore Durometer in Shore Units on a 0-100 SU scale.
- Rate of postoperative pancreatic fistula [ Time Frame: 3 months postoperatively ]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.
|Study Start Date:||August 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
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.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400100
|Department of Surgery, St. Josef Hospital, Ruhr University of Bochum|
|Bochum, NRW, Germany, 44791|
|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|