Randomized controlled trial comparing somatostatin with octreotide in the prevention of complications after pancreatectomy.

BACKGROUND/AIMS: The postoperative morbidity following pancreaticoduodenectomy (PD) remains very high. Somatostatin or octreotide are indicated in the prevention of pancreatic stump-related complications. The aim of this study is to compare the efficacy of somatostatin and octreotide after PD.

METHODOLOGY

Between November 2000 and December 2003 we collected prospectively clinical and biological data from patients with a benign or malignant pancreatic tumor requiring a PD. Fifty patients were randomized into two groups, 25 treated with somatostatin (group S) and 25 with octreotide (group O).

RESULTS

There was no postoperative death. Complications occurred in 20 patients (40%), 11 in group S, 9 in group O (NS). General complications occurred in 7 patients in group S, and 5 patients in group O. Local complications related to the pancreatic stump were found in 4 patients in both groups. At the end of the period of administration of the two study drugs, 2 patients (8%) had a pancreatic fistula in group S and 3 in group O (12%) (p=0.52). A trend of more rapid decreased level of amylase and lipase concentrations in surgical drainage was observed in group S but it is not statistically significant (p=0.29).

CONCLUSIONS

In patients requiring PD for pancreatic tumor, somatostatin and octreotide seem to behave similarly in the postoperative period.