Skip to content

Trial · Interventional

CompletedNot applicableRegistry data

Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy

Short name PD

NCTNCT02474914 (opens ClinicalTrials.gov in a new tab)Other idOctreotide PD
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
104 participants (actual)
Sponsor
Mansoura University · Other
Design
Randomized · Double masking
Countries
1 country

Egypt

Start
May 2014
Primary completion
Apr 2017
Completion
Apr 2017
First posted
18 Jun 2015 (estimated)
Last update posted
22 Aug 2017
Conditions
Periampullary Carcinoma Resectable

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015201620172018
  1. N/A

    PD

    NCT02474914

    May 2014 to Apr 2017

Registry summary

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

pancreaticoduodenectomy (PD) is the standard operation for treatment of patients with benign and malignant pancreatic and periampullary diseases. Despite improved surgical technique and postoperative care, the mortality rate after PD is high reaching up to 30%, due to high incidence of postoperative complications . Pancreatic fistula (PF) is the one of the most frequent complications of PD and the major contributor to postoperative morbidity The aim of this study to evaluate the effect of the perioperative octreotide use after PD for prevention of the postoperative pancreatic fistula. The secondary outcomes are overall postoperative complications, mortality and the cost benefit relationship of the use of the perioperative octreotide.

Interventions

  • OctreotideDrug
  • PlaceboDrug

Arms2

  • Active comparator

    Octreotide

    Enrolled patients will be randomized to either the octreotide (sandostatin ) or the placebo group. The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy . Patients in the octreotide group will receive sandostatin 100ug SC every 8 hours daily staring from the day of operation to the postoperative day 7. Patients in the placebo group will receive saline administered in a similar manner.

  • Placebo comparator

    Placebo

    pancreaticoduodenectomy without octreotide postoperative

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. the rate of development of postoperative pancreatic fistula

    Time frame · 30 day

    Registry description

    POPF was defined by International Study Group of Pancreatic Fistula (ISGPF) as any volume of drained fluid on or after postoperative day (POD) 3 with amylase content greater than 3 times the serum amylase activity . POPF was graded into Grade A, B, and C according to the clinical course

Secondary outcomes(2)

  1. Delayed gastric emptying

    Time frame · 30 days

    Registry description

    Delayed gastric emptying was defined as output from a nasogastric tube of greater than 500 ml per day that persisted beyond 10th POD, the failure to maintain oral intake by 14th POD, or reinsertion of a nasogastric tube. Biliary leak was defined as the presence of bile in the drainage fluid that persists to 4th POD

  2. duration of the hospital length of stay

    Time frame · 30 days

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

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

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)

Indexing hint: Randomized controlled trial · 1995

3 results

Efficacy of octreotide in the prevention of pancreatic fistula after elective pancreatic resections: a prospective, controlled, randomized clinical trial.

Montorsi et al. 1995Surgerycited by 198

PMID 7809832DOI 10.1016/s0039-6060(05)80225-9PUB-07809832

Full text at the publisher3 results
Publisher pageSee results (3)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2013

Prospective randomized trial of the effect of octreotide on pancreatic juice output after pancreaticoduodenectomy in relation to histological diagnosis, duct size and leakage.

Fernández-Cruz et al. 2013HPB : the official journal of the International Hepato Pancreato Biliary Associationcited by 34

PMID 23557411PMC3633042DOI 10.1111/j.1477-2574.2012.00608.xPUB-23557411

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • ResultEl Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5. PMID 23494109
  • ResultPenumadu P, Barreto SG, Goel M, Shrikhande SV. Pancreatoduodenectomy - preventing complications. Indian J Surg Oncol. 2015 Mar;6(1):6-15. doi: 10.1007/s13193-013-0286-z. Epub 2014 Jan 19. PMID 25937757
  • ResultHashimoto D, Chikamoto A, Ohmuraya M, Hirota M, Baba H. Pancreaticodigestive anastomosis and the postoperative management strategies to prevent postoperative pancreatic fistula formation after pancreaticoduodenectomy. Surg Today. 2014 Jul;44(7):1207-13. doi: 10.1007/s00595-013-0662-x. Epub 2013 Jul 11. PMID 23842691

Eligibility

Who could join, as posted.

Sex
All
Age
from 10 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. All patients with pancreatic and periampullary tumours anticipated for PD will be eligible to participate in this trial. 2. patients with non dilated pancreatic duct and soft pancreas Exclusion Criteria: Exclusion criteria: 1. Age over 70. 2. Patients who underwent total or distal pancreatic resection. 3. Patients with unresectable disease who will undergo any surgical procedure other than PD for pancreatic and periampullary tumours. 4. Patients underwent neoadjuvant chemotherapy or radiotherapy. 5. PD more than 3mm. 6. firm pancreas. 7. PJ

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