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NCT Number: NCT02474914

Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy

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.

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Key information

Conditions

Periampullary Carcinoma Resectable

Age range

10 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ayman El Nakeeb

Al Mansurah, Mansoura, 356111, Egypt

About this study

This study will be a prospective randomized controlled trial for perioperative use of octreotide in patients after PD for pancreatic and periampullary tumours from May 2014 to April 2017 in Gastroenterology surgical center, Mansoura University, Egypt.

The primary outcome of the study is the effect of perioperative use of octreotide on the rate of development of postoperative pancreatic fistula in patients after PD for pancreatic and periampullary tumours. The secondary outcome is postoperative overall complications, mortality, duration of the hospital length of stay and cost-benefit relationship of perioperative use of octreotide.

Enrolled patients will be randomized to either the octreotide 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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy .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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with pancreatic and periampullary tumours anticipated for PD will be eligible to participate in this trial.
  • patients with non dilated pancreatic duct and soft pancreas

Exclusion criteria

Exclusion criteria

  • Age over 70.
  • Patients who underwent total or distal pancreatic resection.
  • Patients with unresectable disease who will undergo any surgical procedure other than PD for pancreatic and periampullary tumours.
  • Patients underwent neoadjuvant chemotherapy or radiotherapy.
  • PD more than 3mm.
  • firm pancreas.
  • PJ

Treatment and study plan

Octreotide

Drug

Octreotide will be given after PD

Other names: sandostatin

Placebo

Drug

Octreotide will NOT be given after PD

Other names: Normal saline

Primary outcomes

  1. the rate of development of postoperative pancreatic fistula

    Time frame: 30 day

    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

  1. Delayed gastric emptying

    Time frame: 30 days

    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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Efficacy of Octreotide in the Prevention of Postoperative Complications After Pancreaticodudenectomy in Patients With Soft Pancreas and Non-dilated Pancreatic Duct: A Prospective Randomized Trial"

Acronym: PD

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 18, 2015
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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