Octreotide in the Prevention of Postoperative Complications After Pancreaticoduodenectomy

Study Overview
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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.

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 The randomization process will be done using closed envelop method and will be withdrawn by a nurse after pancreaticoduodenectomy .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

Official Title
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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

Conditions
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Periampullary Carcinoma Resectable

Intervention / Treatment
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* Drug: Octreotide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Octreotide<br>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. | Drug: Octreotide<br>* Octreotide will be given after PD<br>* Other names: sandostatin;|
| Placebo Comparator: Placebo<br>pancreaticoduodenectomy without octreotide postoperative | Drug: Placebo<br>* Octreotide will NOT be given after PD<br>* Other names: Normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of development of postoperative pancreatic fistula | 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 | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delayed gastric emptying | 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 | 30 days | 
| duration of the hospital length of stay |  | 30 days |