Evidence map›Paper›PMID 39888467›Full record

ArticleAnnals of surgical oncology2025

A Composite Endpoint of Liver Surgery (CELS): Development and Validation of a Clinically Relevant Endpoint Requiring a Smaller Sample Size.

Jun Kawashima, Miho Akabane, Yutaka Endo, Selamawit Woldesenbet, Mujtaba Khalil, Kota Sahara, Andrea Ruzzenente, Luca Aldrighetti, Todd W Bauer, Hugo P Marques and 18 more

Abstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Annals of surgical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. International Benchmark Values for Robotic Right Hepatectomy: Multicenter Study From 22 Expert Centers.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Jun KawashimaDepartment of Surgery, The Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, OH, USA.
Miho AkabaneDepartment of Surgery, The Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, OH, USA.
Yutaka EndoDepartment of Transplant Surgery, University of Rochester Medical Center, Rochester, NY, USA.
Selamawit WoldesenbetDepartment of Surgery, The Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, OH, USA.
Mujtaba KhalilDepartment of Surgery, The Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, OH, USA.
Kota SaharaDepartment of Gastroenterological Surgery, Yokohama City University School of Medicine, Yokohama, Japan.
Andrea RuzzenenteDepartment of Surgery, University of Verona, Verona, Italy.
Luca AldrighettiDepartment of Surgery, Ospedale San Raffaele, Milan, Italy.
Todd W BauerDepartment of Surgery, University of Virginia, Charlottesville, VA, USA.
Hugo P MarquesDepartment of Surgery, Curry Cabral Hospital, Lisbon, Portugal.
Rita LopesDepartment of Surgery, Curry Cabral Hospital, Lisbon, Portugal.
Sara OliveiraDepartment of Surgery, Curry Cabral Hospital, Lisbon, Portugal.
Guillaume MartelDepartment of Surgery, University of Ottawa, Ottawa, ON, Canada.
Irinel PopescuDepartment of Surgery, Fundeni Clinical Institute, Bucharest, Romania.
Mathew J WeissDepartment of Surgery, Northwell Health, New Hyde Park, NY, USA.
Minoru KitagoDepartment of Surgery, Keio University, Tokyo, Japan.
George PoultsidesDepartment of Surgery, Stanford University, Stanford, CA, USA.
Kazunari SasakiDepartment of Surgery, Stanford University, Stanford, CA, USA.
Shishir K MaithelDepartment of Surgery, Emory University, Atlanta, GA, USA.
Tom HughDepartment of Surgery, The University of Sydney, Sydney, NSW, Australia.
Ana GleisnerDepartment of Surgery, University of Colorado Denver, Denver, CO, USA.
Federico AucejoDepartment of General Surgery, Cleveland Clinic Foundation, Cleveland, OH, USA.
Carlo PulitanoDepartment of Surgery, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.
Feng ShenDepartment of Surgery, Eastern Hepatobiliary Surgery Hospital, Shanghai, China.
François CauchyDepartment of Hepatobiliopancreatic Surgery, APHP, Beaujon Hospital, Clichy, France.
Bas Groot KoerkampDepartment of Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Itaru EndoDepartment of Gastroenterological Surgery, Yokohama City University School of Medicine, Yokohama, Japan.
Timothy M PawlikDepartment of Surgery, The Ohio State University Wexner Medical Center and James Comprehensive Cancer Center, Columbus, OH, USA. Tim.Pawlik@osumc.edu.ORCID http://orcid.org/0000-0002-7994-9870

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsPatients 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.

resultsAmong 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.

conclusionCELS 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.

Indexed as

Bile Duct NeoplasmsCarcinoma, HepatocellularCholangiocarcinomaColorectal NeoplasmsHepatectomyLiver NeoplasmsPostoperative ComplicationsAgedFemaleFollow-Up StudiesHumansLength of StayMaleMiddle AgedPrognosisRetrospective Studies

Identifiers

PMID39888467
PMCPMC11976826

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.