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Cited by 5Colorectal Cancer Treatments and StudiesColorectal Cancer Surgical TreatmentsEnhanced Recovery After Surgery

EORTC 1409 GITCG/ESSO 01—A prospective colorectal liver metastasis database for borderline or initially unresectable diseases (CLIMB): Lessons learnt from real life. From paradigm to unmet need

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Collienne, Maike, Neven, Anouk, Caballero, Carmela, Kataoka, Kozo, Carrion-Alvarez, Lucia, Nilsson, Henrik, Désolneux, Grégoire, Rivoire, Michel +13 more·2023·European Journal of Surgical Oncology
DOI 10.1016/j.ejso.2023.107081
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Abstract

Aim Multidisciplinary management of metastatic colorectal liver metastases (CRLM) is still challenging. To assess postoperative complications in initially unresectable or borderline resectable CRLM, the prospective EORTC-1409 ESSO 01-CLIMB trial capturing 'real-life data' of European centres specialized in liver surgery was initiated. Material and methods A total of 219 patients were registered between May 2015 and January 2019 from 15 centres in nine countries. Eligible patients had borderline or initially unresectable CRLM assessed by pre-operative multidisciplinary team discussion (MDT). Primary endpoints were postoperative complications, 30-day and 90-days mortality post-surgery, and quality indicators. We report the final results of the 151 eligible patients that underwent at least one liver surgery. Results Perioperative chemotherapy with or without targeted treatment were administered in 100 patients (69.4%). One stage resection (OSR) was performed in 119 patients (78.8%). Two stage resections (TSR, incl. Associating Liver Partition and Portal Vein Ligation for Staged hepatectomy (ALPPS)) were completed in 24 out of 32 patients (75%). Postoperative complications were reported in 55.5% (95% CI: 46.1-64.6%), 64.0% (95% CI: 42.5-82%), and 100% (95% CI: 59-100%) of the patients in OSR, TSR and ALPPS, respectively. Post-hepatectomy liver failure occurred in 6.7%, 20.0%, and 28.6% in OSR, TSR, and ALPPS, respectively. In total, four patients (2.6%) died after surgery. Conclusion Across nine countries, OSR was more often performed than TSR and tended to result in less postoperative complications. Despite many efforts to register patients across Europe, it is still challenging to set up a prospective CRLM database.

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  • Most publications are underpowered to assess CR-PHLF with event rates of 5-15%, with commonly less than 50 patients included per study.

    “With commonly less than 50 patients included per study, most publications are underpowered to assess CR-PHLF with event rates of 5–15% according to the literature [5,7,13,38,39].”

    From The Role of Perioperative Interleukin-6 Serum Levels on Liver Dysfunction and Infectious Complications After Hepatectomy—A Systematic Review (2025) · cites this paper as [39]

    The Discussion (page unavailable) says this registry’s subgroup comparisons had wide confidence intervals because of low numbers, and the Results report post-hepatectomy liver-failure rates. It does not establish that most publications are underpowered, commonly include fewer than 50 patients per study, or have CR-PHLF event rates of 5–15%. (LLM, conf=0.76)

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Authors
Collienne, M., Neven, A., Caballero, C., Kataoka, K., Carrion-Alvarez, L., Nilsson, H., Désolneux, G., Rivoire, M., Ruers, T., Gruenberger, T., Protic, M., Troisi, R. I., Primavesi, F., Staettner, S., Rahbari, N., Schnitzbauer, A., Malik, H., Swijnenburg, R.-J., Mauer, M., Ducreux, M., & Evrard, S.
Affiliations
  • European Organisation for Research and Treatment of Cancer (BE)
  • European Organisation for Research and Treatment of Cancer (NL)
  • Breast International Group (BE)
  • Hyogo Medical University (JP)
  • Karolinska Institutet (SE)
  • Centre Léon Bérard (FR)
  • The Netherlands Cancer Institute (NL)
  • Sigmund Freud Privatuniversität Wien (AT)
  • Ghent University (BE)
  • Innsbruck Medical University (AT)
  • University Medical Centre Mannheim (DE)
  • Goethe University Frankfurt (DE)
  • Aintree University Hospitals NHS Foundation Trust (GB)
  • Leiden University Medical Center (NL)
  • Inserm (FR)
Corresponding author
Collienne, Maike
ORCID
Venue
European Journal of Surgical Oncology
Publisher
Elsevier BV
Published
2023-11
Volume
49
Issue
11
Pages
107081
ISSN
0748-7983 (ISSN-L)
DOI
10.1016/j.ejso.2023.107081
OpenAlex
W4387022457
Cited by
5
References
0
Citations by year
2025: 3 · 2024: 2
FWCI
0.61
Type
journal article
Language
en
Open access
Licence
Locations
  • European Journal of Surgical Oncology (publishedVersion)
  • PubMed (publishedVersion)
  • Pure Amsterdam UMC (submittedVersion, other-oa)
Funders
  • European Society of Surgical Oncology
  • European Organisation for Research and Treatment of Cancer
Topics
  • Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
  • Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
  • Health Sciences › Medicine › Surgery › Enhanced Recovery After Surgery
Keywords
colorectal liver metastases, borderline resectable disease, postoperative complications, perioperative chemotherapy, ALPPS, staged hepatectomy, one-stage resection, post-hepatectomy liver failure, postoperative mortality, multidisciplinary team assessment, real-world data
MeSH terms
Hepatectomy, Humans, Ligation, Liver, Liver Neoplasms, Portal Vein, Postoperative Complications, Prospective Studies, Colorectal Neoplasms, Treatment Outcome

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