Skip to content

Trial · Interventional

CompletedPhase 4Registry data

Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas

Short name PD

NCTNCT01301222 (opens ClinicalTrials.gov in a new tab)Other idPVSMHEC
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
110 participants (actual)
Sponsor
PVS Memorial Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

India

Start
Sept 2010
Primary completion
Sept 2014
Completion
Feb 2015
First posted
23 Feb 2011 (estimated)
Last update posted
24 Feb 2015 (estimated)
Conditions
Pancreatic Fistula

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013201420152016
  1. Ph 4

    PD

    NCT01301222

    Sept 2010 to Feb 2015

Registry summary

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

This randomized controlled trial (RCT) aims at assessing the influence of octreotide on pancreatic fistula or complications following pancreatoduodenectomy in patients with soft pancreas. Previously reported trials have included all types of pancreatic resections and have include all types of pancreas and have shown no clearcut benefit of octreotide after pancreaticoduodenectomy (PD). Soft pancreas and normal sized duct are the risk factors for fistula following PD. This study's focus is on this select group of patients and aims to assess the role of octreotide in patients with soft pancreas.

Interventions

  • Inj. OctreotideDrug

Arms1

  • Experimental

    octreotide

    octreotide arm 100mcg for 5 days. control has no octreotide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Pancreatic fistula

    Time frame · 30 days

    Registry description

    All grades of postoperative pancreatic fistula as per ISGPF definition

Secondary outcomes(1)

  1. complications

    Time frame · 30 days

    Registry description

    All outcome measures like oral liquid feeds, semisolid food,hospital stay and complications like bleeding, intra-abdominal collections, respiratory complications, DGE etc are monitored

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.

Completed trials do not always post results.

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

Studies4

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2015

4 results

Octreotide Does Not Prevent Pancreatic Fistula Following Pancreatoduodenectomy in Patients with Soft Pancreas and Non-dilated Duct: A Prospective Randomized Controlled Trial.

Kurumboor et al. 2015Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tractcited by 50

PMID 26302879DOI 10.1007/s11605-015-2925-xPUB-26302879

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2004

5 results

Octreotide in the prevention of intra-abdominal complications following elective pancreatic resection: a prospective, multicenter randomized controlled trial.

Suc et al. 2004Archives of surgery (Chicago, Ill. : 1960)cited by 113

PMID 15006886DOI 10.1001/archsurg.139.3.288PUB-15006886

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Randomized controlled trial · 2000

4 results

Does prophylactic octreotide decrease the rates of pancreatic fistula and other complications after pancreaticoduodenectomy? Results of a prospective randomized placebo-controlled trial.

Yeo et al. 2000Annals of surgerycited by 373

PMID 10973392DOI 10.1097/00000658-200009000-00014PUB-10973392

Rights unknown4 results
Source linkSee results (4)

More studies

1 study on this page

PubMed tag: none · 2007

Selective administration of prophylactic octreotide during pancreaticoduodenectomy: a clinical and cost-benefit analysis in low- and high-risk glands.

Vanounou et al. 2007Journal of the American College of Surgeonscited by 36

PMID 17903728DOI 10.1016/j.jamcollsurg.2007.05.011PUB-17903728

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 25 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:elective surgery patients undergoing pancreatoduodenectomy * soft pancreas, no dilated duct Exclusion Criteria: * age \> 75 years old * documented chronic pancreatitis * previous pancreatic surgery * previous gastric surgery vagotomy * documented pancreatic duct dilatation

PepBank is a research reference. Talk to a doctor before you use any peptide.