Activity ID
8440Expires
May 12, 2024Format Type
Journal-basedCME Credit
1Fee
$30CME Provider: JAMA Surgery
Description of CME Course
Importance 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.
Objective To establish the safety of combined division of the splenic vein compared with separate division of the splenic vein.
Design, Setting, and Participants 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.
Interventions Patients were centrally randomized (1:1) to either separate division of the splenic vein or combined division of the splenic vein.
Main Outcomes and Measures 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.
Results 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%.
Conclusions and Relevance This study demonstrated noninferiority of the combined division of the splenic vein compared with separate division of the splenic vein regarding safety. Thus, isolating the splenic vein from the pancreatic parenchyma is deemed unnecessary.
Trial Registration ClinicalTrials.gov Identifier: NCT02871804
Disclaimers
1. This activity is accredited by the American Medical Association.
2. This activity is free to AMA members.
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NoNOTE: If a Member Board has not deemed this activity for MOC approval as an accredited CME activity, this activity may count toward an ABMS Member Board’s general CME requirement. Please refer directly to your Member Board’s MOC Part II Lifelong Learning and Self-Assessment Program Requirements.
Educational Objectives
To identify via a noninferiority randomized clinical trial whether combined (vs separate) division of the splenic vein is safe in performing a distal pancreatectomy.
Keywords
Gastrointestinal Surgery, Pancreatic Surgery, Surgery, Gastroenterology, Gastroenterology and Hepatology
Competencies
Medical Knowledge
CME Credit Type
AMA PRA Category 1 Credit
DOI
10.1001/jamasurg.2021.0108