Randomized Controlled Trial of Pancreaticojejunostomy versus Stapler Closure of the Pancreatic Stump During Distal Pancreatectomy to Reduce Pancreatic Fistula

Abstract

Objectives: The aim of this study was to evaluate in a multicenter randomized controlled trial (RCT) whether pancreaticojejunostomy (PJ) of pancreatic stump decreases the incidence of pancreatic fistula after distal pancreatectomy (DP) compared with stapler closure.

Background: Several studies reported that PJ of pancreatic stump reduces the incidence of pancreatic fistula after DP. However, no RCT has confirmed the efficacy of PJ of pancreatic stump.

Methods: One hundred thirty-six patients scheduled for DP were enrolled in this study between June 2011 and March 2014 at 6 high-volume surgical centers in Japan. Enrolled patients were randomized to either stapler closure or PJ. The primary endpoint was the incidence of pancreatic fistula based on the International Study Group on Pancreatic Fistula criteria. This RCT was registered with ClinicalTrials.gov (NCT01384617).

Results: Sixty-one patients randomized to stapler and 62 patients randomized to PJ were analyzed by intention-to-treat. Pancreatic fistula occurred in 23 patients (37.7%) in the stapler closure group and 24 (38.7%) in the PJ group (P = 0.332) in intention-to-treat analysis. The incidence of clinically relevant pancreatic fistula (grade B or C) was 16.4% for stapler closure and 9.7% for PJ (P = 0.201). Mortality was zero in both groups. In a subgroup analysis for thickness of pancreas greater than 12 mm, the incidence of clinically relevant pancreatic fistula occurred in 22.2% of the patients in the stapler closure group and in 6.2% of the PJ group (P = 0.080).

Conclusions: PJ of the pancreatic stump during DP does not reduce pancreatic fistula compared with stapler closure.

FIGURE 1

In the stapler closure group (a), the pancreatic parenchyma was transected using Echelon 60 with a gold cartridge (Ethicon Endo-Surgery, Cincinnati, OH). Echelon 60 with a gold cartridge provides precise and uniform wide compression throughout the entire 60-mm length, with compressible thickness to 1.8 mm, and can attach 2 triple-staggered rows of titanium staples. In the PJ group (b), PJ end-to-side anastomosis by a Roux-en-Y limb for the pancreatic stump was performed via a retrocolic route with an appropriate length of the first jejunal loop (at least 30 cm). The anastomosis was performed in a nonstented duct-to-mucosa fashion.

FIGURE 2

Consort diagram for the trial.