A Composite Endpoint of Liver Surgery (CELS): Development and Validation of a Clinically Relevant Endpoint Requiring a Smaller Sample Size Article Swipe
Jun Kawashima
,
Miho Akabane
,
Yutaka Endo
,
Selamawit Woldesenbet
,
Mujtaba Khalil
,
Kota Sahara
,
Andrea Ruzzenente
,
Luca Aldrighetti
,
Todd W. Bauer
,
Hugo P. Marques
,
Rita de Cássia Sobreira Lopes
,
Sara Oliveira
,
Guillaume Martel
,
Irinel Popescu
,
Matthew J. Weiss
,
Minoru Kitago
,
George A. Poultsides
,
Kazunari Sasaki
,
Shishir K. Maithel
,
Tom Hugh
,
Ana Gleisner
,
Federico Aucejo
,
Carlo Pulitanò
,
Feng Shen
,
François Cauchy
,
Bas Groot Koerkamp
,
Itaru Endo
,
Timothy M. Pawlik
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1245/s10434-025-16965-y
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1245/s10434-025-16965-y
Background The feasibility of trials in liver surgery using a single-component clinical endpoint is low because single endpoints require large samples due to their low incidence. The current study sought to develop and validate a novel composite endpoint of liver surgery (CELS) to facilitate the generation of more feasible and robust high-level evidence in the field of liver surgery. Methods Patients who underwent curative-intent hepatectomy for hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or colorectal liver metastasis were identified using a multi-institutional database. Components of CELS were selected based on perioperative liver surgery-specific complications using univariable logistic regression models. The association of CELS with prolonged length of stay (LOS) and surgery-related death was evaluated and externally validated. Sample sizes were calculated for both individual outcomes and CELS. Results Among 1958 patients, 377 (19.3%) met CELS criteria based on postoperative bile leak ( n = 221, 11.3%), post-hepatectomy liver failure ( n = 71, 3.6%), post-hepatectomy hemorrhage ( n = 38, 1.9%), or intraoperative blood loss of 2000 ml or greater ( n = 101, 5.2%). CELS demonstrated favorable discriminative accuracy of surgery-related death (analytic cohort: area under the curve [AUC], 0.79 vs external validation cohort: AUC, 0.85). In addition LOS was longer among the patients with a positive CELS (analytic cohort: 14 vs. 9 days [ p < 0.001] vs. the validation cohort: 10 vs. 6 days [ p < 0.001]). Relative to individual endpoints, CELS allowed a 45.8–91.6% reduction in sample size. Conclusion CELS effectively predicted surgery-related death and can be used as a standardized, clinically relevant endpoint in prospective trials, facilitating smaller sample sizes and enhancing feasibility compared with single quality outcome metrics.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1245/s10434-025-16965-y
- OA Status
- hybrid
- Cited By
- 3
- References
- 45
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4407009354
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4407009354Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1245/s10434-025-16965-yDigital Object Identifier
- Title
-
A Composite Endpoint of Liver Surgery (CELS): Development and Validation of a Clinically Relevant Endpoint Requiring a Smaller Sample SizeWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2025Year of publication
- Publication date
-
2025-01-31Full publication date if available
- Authors
-
Jun Kawashima, Miho Akabane, Yutaka Endo, Selamawit Woldesenbet, Mujtaba Khalil, Kota Sahara, Andrea Ruzzenente, Luca Aldrighetti, Todd W. Bauer, Hugo P. Marques, Rita de Cássia Sobreira Lopes, Sara Oliveira, Guillaume Martel, Irinel Popescu, Matthew J. Weiss, Minoru Kitago, George A. Poultsides, Kazunari Sasaki, Shishir K. Maithel, Tom Hugh, Ana Gleisner, Federico Aucejo, Carlo Pulitanò, Feng Shen, François Cauchy, Bas Groot Koerkamp, Itaru Endo, Timothy M. PawlikList of authors in order
- Landing page
-
https://doi.org/10.1245/s10434-025-16965-yPublisher landing page
- Open access
-
YesWhether a free full text is available
- OA status
-
hybridOpen access status per OpenAlex
- OA URL
-
https://doi.org/10.1245/s10434-025-16965-yDirect OA link when available
- Concepts
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Medicine, Hepatectomy, Perioperative, Cohort, Clinical endpoint, Hepatocellular carcinoma, Surgical oncology, Internal medicine, Surgery, Sample size determination, Gastroenterology, Oncology, Clinical trial, Resection, Statistics, MathematicsTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
3Total citation count in OpenAlex
- Citations by year (recent)
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2025: 3Per-year citation counts (last 5 years)
- References (count)
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45Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| sustainable_development_goals[0].score | 0.6600000262260437 |
| sustainable_development_goals[0].display_name | Reduced inequalities |
| citation_normalized_percentile.value | 0.95740726 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | True |