Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

Not Applicable

• Conditions: Periampullary Tumors
• Interventions: Drug: Octreotide; Drug: Placebo

• Registration Number: NCT02920567
• Lead Sponsor: Saint Vincent's Hospital, Korea

Brief 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.

Study Timeline

• Study Start: 2014-01
• Status Verified: 2016-09
• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-28
• Last Update Submitted: 2016-09-28
• Study First Posted: 2016-09-30
• Last Update Posted: 2016-09-30
• Primary Completion: 2018-06
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Patients who will undergo pancreatoduodenectomy for periampullary tumors

Exclusion Criteria

• Patients with preoperative pancreatitis
• Patients who did not undergo pancreatoduodenectomy
• Patients who underwent bypass surgery or total pancreatectomy
• Patients who injection of octreotide less than 5 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Amount of pancreatic secretion	1 day

Secondary Outcome Measures

Name	Time	Method
Rate of pancreatic fistula	1 day

Trial Locations

Locations (1)

the Catholic University of Korea St. Vincent's Hospital; 🇰🇷 Suwon, Korea, Republic of