title: Prospective, randomized trial of octreotide to prevent pancreatic fistula after pancreaticoduodenectomy for malignant disease.
abstract: OBJECTIVE
  This study was conducted to determine whether the perioperative administration of octreotide decreases the incidence of pancreatic anastomotic leak after pancreaticoduodenectomy for malignancy.
  
  
  BACKGROUND
  Three multicenter, prospective, randomized trials concluded that patients who receive octreotide during and after pancreatic resection have a reduction in the total number of complications or a decreased incidence of pancreatic fistula. However, in the subset of patients who underwent pancreaticoduodenectomy for malignancy, either no analysis was performed or no benefit from octreotide could be demonstrated.
  
  
  METHODS
  A single-institution, prospective, randomized trial was conducted between June 1991 and December 1995 involving 120 patients who were randomized to receive octreotide (150 microg subcutaneously every 8 hours through postoperative day 5) or no further treatment after pancreaticoduodenectomy for malignancy. The surgical technique was standardized, and the pancreaticojejunal anastomosis was created using the duct-to-mucosa or invagination technique.
  
  
  RESULTS
  The two patient groups were similar with respect to patient demographics, treatment variables, and histologic diagnoses. The rate of clinically significant pancreatic leak was 12% in the octreotide group and 6% in the control group (p = 0.23). Perioperative morbidity was 30% and 25%, respectively. Patients who underwent reoperative pancreaticoduodenectomy had an increased incidence of pancreatic anastomotic leak, whereas those who received preoperative chemoradiation had a decreased incidence of pancreatic anastomotic leak.
  
  
  CONCLUSIONS
  The routine use of octreotide after pancreaticoduodenectomy for malignancy cannot be recommended.
authors.affiliation: Department of Surgical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
authors.forename: A M
authors.initials: AM
authors.lastname: Lowy
authors.forename: J E
authors.initials: JE
authors.lastname: Lee
authors.forename: P W
authors.initials: PW
authors.lastname: Pisters
authors.forename: B S
authors.initials: BS
authors.lastname: Davidson
authors.forename: C J
authors.initials: CJ
authors.lastname: Fenoglio
authors.forename: P
authors.initials: P
authors.lastname: Stanford
authors.forename: R
authors.initials: R
authors.lastname: Jinnah
authors.forename: D B
authors.initials: DB
authors.lastname: Evans
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006728:Hormones / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000627:therapeutic use*; D010185:Pancreatic Fistula / Q000453:epidemiology / Q000517:prevention & control*; D016577:Pancreaticoduodenectomy / Q000009:adverse effects* / Q000379:methods; D011446:Prospective Studies
chemical_list: D006728:Hormones; D015282:Octreotide