Sandostatin in the Prevention of Postoperative Complications After Pancreaticoduodenectomy

Condition(s) targeted: Periampullary Carcinoma Resectable

Intervention: Octreotide (Drug); Placebo (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Mansoura University

Official(s) and/or principal investigator(s):
Ayman El Nakeeb, MD, Principal Investigator, Affiliation: Mansoura University

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.

Official title: Efficacy of Sandostatin in the Prevention of Postoperative Complications After Pancreaticoduodenectomy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: the rate of development of postoperative pancreatic fistula

Secondary outcome:

Delayed gastric emptying

duration of the hospital length of stay

Detailed 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 2015 to April 2016 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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy .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.

Minimum age: 10 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. All patients with pancreatic and periampullary tumours anticipated for PD will be eligible to participate in this trial. 2. All types of pancreatic resections including pylorus preserving PD. 3. All types of pancreatic reconstructions including end-to-end, end-to-side, invaginated, isolated and duct-to-mucosa pancreaticojejunostomy and pancreaticogastrostomy. 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 smaller than 3mm. 6. Soft pancreas. 7. Posteriorly situated duct.

Ayman El Nakeeb, Mansoura 356111, Egypt

Related publications:

Lowy AM, Lee JE, Pisters PW, Davidson BS, Fenoglio CJ, Stanford P, Jinnah R, Evans DB. Prospective, randomized trial of octreotide to prevent pancreatic fistula after pancreaticoduodenectomy for malignant disease. Ann Surg. 1997 Nov;226(5):632-41. Review.

Starting date: May 2015
Last updated: June 17, 2015