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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Octreotide | Experimental | Study patients receive after randomization a single shot of 5 mL 500 µg Octreotide in the gastroduodenal artery at the time of its transection. |
|
| Control | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraarterial application of Octreotide | Drug | 500 µg / 5 ml Octreotide is given as a single bolus injection in the gastroduodenal artery intraoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orlin Belyaev, MD | Department of Surgery, St. Josef Hospital | Study Director |
| Christian Polle | Ruhr University of Bochum | Principal Investigator |
| Waldemar Uhl, MD, PhD | Department of Surgery, St. Josef Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, St. Josef Hospital, Ruhr University of Bochum | Bochum | North Rhine-Westphalia | 44791 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16568326 | Background | 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. | |
| 15726611 | Background | 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. |
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| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005402 | Fistula |
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| ID | Term |
|---|---|
| D015282 | Octreotide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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|
| sterile NaCl (sodium chloride) 0,9% solution | Drug | a single intraarterial shot of 5 ml saline solution in the gastroduodenal artery |
|
|
| 19394646 | Background | 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. |
| 23963030 | Derived | 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |