Effects of Intraarterial Octreotide on Pancreatic Texture
|ClinicalTrials.gov Identifier: NCT01400100|
Recruitment Status : Completed
First Posted : July 22, 2011
Last Update Posted : March 6, 2012
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 or disease||Intervention/treatment||Phase|
|Pancreatic Fistula||Drug: Intraarterial application of Octreotide Drug: sterile NaCl (sodium chloride) 0,9% solution||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (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|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||March 2012|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|