Combined division of splenic vein non inferior to separate division In distal pancreatectomy: JAMA

In distal pancreatectomy (DP), the splenic vein is isolated from the pancreatic parenchyma prior to being ligated and divided to prevent intra-abdominal hemorrhage from the splenic vein stump with pancreatic fistula (PF). Conversely, dissecting the splenic vein with the pancreatic parenchyma is easy and time-saving.

With this background, researchers aimed to establish the safety of combined division of the splenic vein compared with separate division of the splenic vein.

This study was designed as a multicenter prospective randomized phase 3 trial. All results were analyzed using the modified intent-to-treat set. Patients undergoing DP for pancreatic body and tail tumors were eligible for inclusion. Patients were randomly assigned between August 10, 2016, and July 30, 2019. Patients were centrally randomized (1:1) to either separate division of the splenic vein or combined division of the splenic vein. The primary end point was the incidence of grade B/C PF, and the incidence of intra-abdominal hemorrhage was included as one of the secondary end points.

Data analysis revealed the following facts.

• A total of 318 patients were randomly assigned, and 2 patients were excluded as ineligible. Of the 316 remaining patients, 150 (50.3%) were male.
• The modified intent-to-treat population constituted 159 patients (50.3%) in the separate division group and 157 patients (49.7%) in the combined division group. In the modified intent-to-treat set, the proportion of grade B/C PF in the separate division group was 27.1% (42 of 155) vs 28.6% (44 of 154) in the combined division group (adjusted odds ratio, 1.108; 95% CI, 0.847-1.225; P = .047), demonstrating noninferiority of the combined division of the splenic vein against separate division.
• The incidence of postoperative intra-abdominal hemorrhage in the 2 groups was identical at 1.3%."In conclusion, the multicenter COSMOS-DP trial successfully demonstrated the noninferiority of combined division of the splenic vein compared with separate division of the splenic vein in terms of the incidence of grade B/C PF. Thus, the safety of this procedure was established such that it could be recommended with more confidence."the team concluded.

For full article follow the link: doi:10.1001/jamasurg.2021.0108

Primary source:JAMA Surgery