Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-04-30

Brief Summary

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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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Detailed Description

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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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy .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.

Conditions

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Periampullary Carcinoma Resectable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Octreotide

Intervention Type DRUG

Octreotide will be given after PD

Placebo

pancreaticoduodenectomy without octreotide postoperative

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Octreotide will NOT be given after PD

Interventions

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Octreotide

Octreotide will be given after PD

Intervention Type DRUG

Placebo

Octreotide will NOT be given after PD

Intervention Type DRUG

Other Intervention Names

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sandostatin Normal saline

Eligibility Criteria

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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

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

Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No