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Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

NCT02920567 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2016-09-30

No results posted yet for this study

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.

Conditions

  • Periampullary Tumors

Interventions

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

Sponsors & Collaborators

  • Saint Vincent's Hospital, Korea

    lead OTHER

Principal Investigators

  • Dong Do You, MD, PhD · The Catholic University of Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-06-30
Completion
2018-07-31

Countries

  • South Korea

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02920567 on ClinicalTrials.gov