Does Prophylactic Octreotide Decrease the Rates of Pancreatic Fistula and Other Complications After Pancreaticoduodenectomy?: Results of a Prospective Randomized Placebo-Controlled Trial

Department of Surgery, Johns Hopkins Hospital, Baltimore, Maryland 21287-4606, USA.
Annals of Surgery (Impact Factor: 8.33). 09/2000; 232(3):419-29. DOI: 10.1097/00000658-200009000-00014
Source: PubMed


To evaluate the endpoints of complications (specifically pancreatic fistula and total complications) and death in patients undergoing pancreaticoduodenectomy.
Four randomized, placebo-controlled, multicenter trials from Europe have evaluated prophylactic octreotide (the long-acting synthetic analog of native somatostatin) in patients undergoing pancreatic resection. Each trial reported significant decreases in overall complication rates, and two of the four reported significantly lowered rates of pancreatic fistula in patients receiving prophylactic octreotide. However, none of these four trials studied only pancreaticoduodenal resections, and all trials had high pancreatic fistula rates (>19%) in the placebo group. A fifth randomized trial from the United States evaluated the use of prophylactic octreotide in patients undergoing pancreaticoduodenectomy and found no benefit to the use of octreotide. Prophylactic use of octreotide adds more than $75 to the daily hospital charge in the United States. In calendar year 1996, 288 patients received octreotide on the surgical service at the authors' institution, for total billed charges of $74,652.
Between February 1998 and February 2000, 383 patients were recruited into this study on the basis of preoperative anticipation of pancreaticoduodenal resection. Patients who gave consent were randomized to saline control versus octreotide 250 microg subcutaneously every 8 hours for 7 days, to start 1 to 2 hours before surgery. The primary postoperative endpoints were pancreatic fistula, total complications, death, and length of hospital stay.
Two hundred eleven patients underwent pancreaticoduodenectomy with pancreatic-enteric anastomosis, received appropriate saline/octreotide doses, and were available for endpoint analysis. The two groups were comparable with respect to demographics (54% male, median age 66 years), type of pancreaticoduodenal resection (60% pylorus-preserving), type of pancreatic-enteric anastomosis (87% end-to-side pancreaticojejunostomy), and pathologic diagnosis. The pancreatic fistula rates were 9% in the control group and 11% in the octreotide group. The overall complication rates were 34% in the control group and 40% in the octreotide group; the in-hospital death rates were 0% versus 1%, respectively. The median postoperative length of hospital stay was 9 days in both groups.
These data demonstrate that the prophylactic use of perioperative octreotide does not reduce the incidence of pancreatic fistula or total complications after pancreaticoduodenectomy. Prophylactic octreotide use in this setting should be eliminated, at a considerable cost savings.

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Available from: Kurtis Campbell, Jan 09, 2014
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    • "Besides different techniques of stump closure, other factors have been considered in PF development after DP: the texture of the pancreatic gland, the use of somatostatin and its analogues (octreotide) and the association with splenectomy. Some studies reported that a non-fibrotic (or soft) pancreas with a small MPD is related to an higher PF rate [19,20]: in our study most cases of both groups had a non-fibrotic pancreas and a small MPD but no PF occurred in the anastomosis groups. The role of somatostatin and its analogues in reducing PF rates after pancreatic surgery is still debated and its use remains controversial [20-24]. "
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    ABSTRACT: Different methods of pancreatic stump closure after distal pancreatectomy (DP) have been described to decrease the incidence of pancreatic fistula (PF) which still represents one of the most common complications in pancreatic surgery. We retrospectively compared the pancreato-jejunostomy technique with the hand-sewn closure of the pancreatic stump after DP, and analyzed clinical outcomes between the two groups, focusing on PF rate. Thirty-six patients undergoing open DP at our institution between May 2005 and December 2011 were included. They were divided in two groups depending on pancreatic remnant management: in 24 cases the stump was closed by hand-sewn suture (Group A), while in 12 earlier cases a pancreato-jejunostomy was performed (Group B). We analyzed postoperative data in terms of mortality, morbidity and length of hospital stay between the two groups. PF occurred in 7 of 24 (29.1%) cases of group A (control group) compared to zero fistula rate in group B (anastomosis group) (p=0.005). Operative time was significantly higher in the anastomosis group (p=0.024). Mortality rate was 0% in both groups. Other postoperative outcomes such as hemorrhages, infections, medical complications and length of hospital stay were not significant between the two groups. Despite a higher operative time, the pancreato-jejunostomy after DP seems to be related to a lower incidence of PF compared to the hand-sewn closure of the pancreatic remnant.
    Full-text · Article · Jul 2013 · BMC Surgery
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    • "In a series of nearly 2000 pancreaticoduodenectomies, it was noted that a soft pancreas was associated with a 22.6% fistula rate and led to a 10-fold increased risk of pancreatic fistula versus an intermediate or hard gland [13]. Other investigations have similarly reported high rates of pancreatic fistula in the presence of soft pancreatic parenchyma [3–6, 14, 15]. In other reports, while 25% of patients with soft pancreatic texture were found to be complicated with pancreatic leak, none of the patients with hard pancreatic remnants developed pancreatic leakage [14, 16]. "
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    ABSTRACT: Resection of pancreas, in particular pancreaticoduodenectomy, is a complex procedure, commonly performed in appropriately selected patients with benign and malignant disease of the pancreas and periampullary region. Despite significant improvements in the safety and efficacy of pancreatic surgery, pancreaticoenteric anastomosis continues to be the "Achilles heel" of pancreaticoduodenectomy, due to its association with a measurable risk of leakage or failure of healing, leading to pancreatic fistula. The morbidity rate after pancreaticoduodenectomy remains high in the range of 30% to 65%, although the mortality has significantly dropped to below 5%. Most of these complications are related to pancreatic fistula, with serious complications of intra-abdominal abscess, postoperative bleeding, and multiorgan failure. Several pharmacological and technical interventions have been suggested to decrease the pancreatic fistula rate, but the results have been controversial. This paper considers definition and classification of pancreatic fistula, risk factors, and preventive approach and offers management strategy when they do occur.
    Full-text · Article · Apr 2012 · International Journal of Surgical Oncology
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    • "Regarding octreotide dosage, 100 mg is the common dose used in most of the trials and is recommended by the manufacturer. Yeo used 250 mg of octreotide and explained that he did not want to influence the results of the trial by insufficient dosage [41]. Sarr used 600 mg of vapreotide twice daily [44]. "
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    ABSTRACT: BACKGROUND: The prophylactic use of somatostatin and its analogs has been suggested to lower the rate of pancreatic fistula. The aim of this review is to discuss the results of published randomized trials and meta-analyses studying the effect of somatostatin and its analogs. METHODS: We performed a Medline search for prospective randomized trials, systematic reviews and meta-analyses with regard to the prophylactic use of somatostatin and its analogs. RESULTS: Eleven randomized trials and six meta-analyses were identified. The randomized trials differ in terms of study designs, diagnosis, operative procedures, drug dosage, time of administration, and the pancreatic fistula definition; therefore, it is advisable to carefully interpret the results of the individual randomized trials. CONCLUSIONS: The routine administration of somatostatin and its analogs in elective pancreatic surgery cannot be recommended. However, selective administration is advisable in cases which carry significantly higher risk of developing pancreatic fistula.
    Full-text · Article · Apr 2011 · European Surgery
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