Role of Somatostatin in the Prevention of Pancreatic Stump‐related Morbidity following Elective Pancreaticoduodenectomy in High‐risk Patients and Elimination of Surgeon‐related Factors: Prospective, Randomized, Controlled Trial

Abstract

A prospective, randomized, controlled trial was performed to determine the efficacy of somatostatin in the prevention of pancreatic stump-related complications with elimination of surgeon-related factors in high-risk patients undergoing pancreaticoduodenectomy. From August 1997 to December 2000, 54 patients, 28 men and 26 women, with age ranged from 32 to 89 years, were randomly assigned to somatostatin group ( n = 27) or placebo group ( n = 27). Ninety-four percent of the patients had pancreatic and periampullary lesions; 6% had secondary lesion involving the duodenum such as local recurrent colon carcinoma and renal cell carcinoma. These patients received either standard pancreaticoduodenectomy or pylorus-preserving pancreaticoduodenectomy. An experienced surgeon performed all operations in same fashion to minimize the surgical factor. A transanastomotic tube was inserted into the pancreatic duct for diversion of pancreatic juice in the pancreaticojejunostomy for a 3-weeks period postoperatively. Intravenous infusion of somatostatin was given at a dose of 250 microg/hr in the somastotatin group and normal saline was given to the control group for 7 days postoperatively. There was one perioperative death in each group, resulting in a 3.7% mortality rate. In the somastotatin group, as compared to the placebo group, the incidence of overall morbidity and pancreatic stump related complications were significantly lower with a mean decrease of 50% pancreatic juice output and a slightly shorter duration of hospital stays. In conclusion, after excluding surgeon related factor, prophylactic use of somatostatin reduces the incidence and severity of pancreatic stump related complications in high-risk patients having pancreaticoduodenectomy via decreased secretion of pancreatic exocrine.

Systematic Review and Meta-Analysis of Somatostatin Analogues in the Prevention of Postoperative Complication after Pancreaticoduodenectomy

“…Unfortunately, a subgroup meta-analysis of high-risk patients cannot be performed because of limited data. However, the studies of Lowy et al [39], Yeo et al [43], and Shan et al [41] showed that SAs could not reduce the rate of PF and other complications in patients at high-risk after PD. In addition, Fernández-Cruz et al [33] further demonstrated no significant differences in median pancreatic juice output were found between SAs and placebo groups in high-risk patients (with a pancreatic duct diameter <5 mm).…”

“…Of the 25 potentially appropriate studies [20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44] seven were excluded for reporting no explicit outcome of PD [20,21,22,23,24,25,27] one for duplicate publication [26] one for comparing somatostatin with octreotide [29] one for using octreotide in the control group [28]. Finally, 15 RCTs were included in the meta-analysis (table 1) [30,31,32,33,34,35,36,37,38,39,40,41,42,43,44]. …”

Outcome of A Non Healing Pancreatico-Cutaneous Fistula, Treated with Local Tetracycline Instillation – A Case Report

“…It reduces gastrointestinal exocrine and endocrine secretions. Randomized control studies have shown conflicting evidence regarding its use for reducing the incidence of developing pancreatic fistulas [10][11][12]. Much of the promising results were seen in high risk patients.…”

“…This includes parenteral nutrition (PN) while resting the bowel, drainage of collections, antibiotics and use of octeotride. However clinical trials have shown conflicting evidence regarding the use of octreotide in managing pancreatic fistulas [10][11][12]. Those which show resistant to healing will need interventions [1].…”

Clinical trials to reduce pancreatic fistula after pancreatic surgery—review of randomized controlled trials

“…Table 4 summarizes RCTs regarding the administration of somatostatin and somatostatin analogues after pancreatic surgery. Two RCTs reported that prophylactic somatostatin or octreotide significantly reduced the incidence of pancreatic fistula after PPPD (39,40). On the other hand, four recent RCTs reported that the use of somatostatin analogues including octreotide and vapreotide, did not reduce pancreatic fistula after pancreas surgery (41)(42)(43)(44)(45).…”