Safety of Combined Division vs Separate Division of the Splenic Vein in Patients Undergoing Distal Pancreatectomy: A Noninferiority Randomized Clinical Trial.
JAMA Surg
; 156(5): 418-428, 2021 05 01.
Article
en En
| MEDLINE
| ID: mdl-33656542
ABSTRACT
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, andParticipants:
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 (11) to either separate division of the splenic vein or combined division of the splenic vein. Main Outcomes andMeasures:
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.
Texto completo:
1
Base de datos:
MEDLINE
Asunto principal:
Pancreatectomía
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Neoplasias Pancreáticas
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Vena Esplénica
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Fístula Pancreática
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Hemorragia Posoperatoria
Tipo de estudio:
Clinical_trials
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Observational_studies
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Risk_factors_studies
Límite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
JAMA Surg
Año:
2021
Tipo del documento:
Article
País de afiliación:
Japón