Periampullary Tumors
Conditions
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.
Interventions
DRUGOctreotide
After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days
DRUGPlacebo
After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days
Sponsors
Saint Vincent's Hospital, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of pancreatic secretion | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Rate of pancreatic fistula | 1 day |
Countries
South Korea
Contacts
Primary ContactDong Do You, MD, PhD
Backup ContactKwang Yeol Paik, MD, Phd
Outcome results
None listed