PROSPECTIVE, RANDOMIZED TRIAL OF OCTREOTIDE TO PREVENT PANCREATIC FISTULA AFTER PANCREATICODUODENECTOMY FOR MALIGNANT DISEASE

Objective This study was conducted to determine whether the perioperat ive administration of octreotide decreases the incidence of pancreatic anastomotic leak after pancreaticoduodenectomy for malignancy. Summar y Background Data Three multicenter, prospective, randomized trials co ncluded that patients who receive octreotide during and after pancreat ic 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 demo nstrated. Methods A single-institution, prospective, randomized trial was conducted between June 1991 and December 1995 involving 120 patien ts who were randomized to receive octreotide (150 mu g subcutaneously every 8 hours through postoperative day 5) or no further treatment aft er 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 v ariables, 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%, respective ly. Patients who underwent reoperative pancreaticoduodenectomy had an increased incidence of pancreatic anastomotic leak, whereas those who received preoperative chemoradiation had a decreased incidence of panc reatic anastomotic leak. Conclusions The routine use of octreotide aft er pancreaticoduodenectomy for malignancy cannot be recommended.