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Trial · Interventional

Status unknownNot applicableRegistry data

Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

Overview

Status
Status unknown
Phase
Not applicable
Enrollment
282 participants (estimated)
Sponsor
Saint Vincent's Hospital, Korea · Other
Design
Randomized · Single masking
Countries
1 country

South Korea

Start
Jan 2014
Primary completion
Jun 2018 (estimated)
Completion
Jul 2018 (estimated)
First posted
30 Sept 2016 (estimated)
Last update posted
30 Sept 2016 (estimated)
Conditions
Periampullary Tumors

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016201720182019
  1. N/A

    Impact of Prophylactic Octreotide to Pancreatic Exocrine Secretion

    NCT02920567

    Jan 2014 to est. Jul 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OctreotideDrug
  • PlaceboDrug

Arms2

  • Experimental

    octreotide

    After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days

  • Placebo comparator

    Placebo

    After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Amount of pancreatic secretion

    Time frame · 1 day

Secondary outcomes(1)
  1. Rate of pancreatic fistula

    Time frame · 1 day

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 1992

4 results

Role of octreotide in the prevention of postoperative complications following pancreatic resection.

Büchler et al. 1992American journal of surgerycited by 276

PMID 1733360DOI 10.1016/0002-9610(92)90264-rPUB-01733360

Full text at the publisher4 results

Indexing hint: In vitro study · 1982

7 results

SMS 201-995: a very potent and selective octapeptide analogue of somatostatin with prolonged action.

Bauer et al. 1982Life sciencescited by 811

PMID 6128648DOI 10.1016/0024-3205(82)90087-xPUB-06128648

Full text at the publisher7 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 19 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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