Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy (PD)

Mansoura University

Status: Completed

Conditions: Periampullary Carcinoma Resectable

Treatments: Drug: Placebo; Drug: Octreotide

Study type: Interventional

Funder types: Other

Identifiers

NCT02474914

Octreotide PD

Details and patient eligibility

About

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.

Full description

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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy .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

Enrollment: 104 patients

Sex: All

Ages: 10 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups, including a placebo group

Octreotide

Active Comparator group

Description:

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.

Treatment:

Drug: Octreotide

Placebo

Placebo Comparator group

Description:

pancreaticoduodenectomy without octreotide postoperative

Treatment:

Drug: Placebo