NCT02920567

Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion and Pancreatic Fistula After Pancreatoduodenectomy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 282 (estimated)
• Sponsor: Saint Vincent's Hospital, Korea · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide was injected subcutaneously every 8 hours for 7 days. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure and amounted. Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.

Detailed description

This study aims to examine whether octreotide has an effect on inhibition of the exocrine secretion fo the pancreas, which might lower the rate of postoperative pancreatic fistula after pancreatoduodenectomy. Patients who will undergo pancreatoduodenectomy for periampullary tumors were enrolled. The patients were randomly assigned to intervention (use of octreotide) or placebo groups. Octreotide of 100ug(1mL) was injected subcutaneously just before operation and every 8 hours for 7 days postoperatively. The placebo group was managed with normal saline (1mL) for same period. Every patients will undergo pancreaticojejunostomy with external stent for remnant pancreas management. The pancreatic juice is drained through the external stent by negative pressure (Barovac) and amounted. Postoperative care of patients was same between groups such as pain control and supportive care. The amount of drained pancreatic juice via external stent was recorded everyday. Primary endpoint was the amount of pancreatic juice for each postoperative day. Secondary endpoint was the rate of pancreatic fistula.

Conditions

• Periampullary Tumors

Interventions

Type	Name	Description
DRUG	Octreotide	After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days
DRUG	Placebo	After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-06-01
• Completion: 2018-07-01
• First posted: 2016-09-30
• Last updated: 2016-09-30

Locations

1 site across 1 country: South Korea