B. Sensi , R. Angelico , L. Toti , M. Alessi , G. D’arcangelo , J. Bloino , G. Tisone , T.M. Manzia
{"title":"肝移植治疗不可切除的结直肠癌肝转移:全球方案、资格标准和移植导向患者评估工具(LT-CLEAR)的开发","authors":"B. Sensi , R. Angelico , L. Toti , M. Alessi , G. D’arcangelo , J. Bloino , G. Tisone , T.M. Manzia","doi":"10.1016/j.dld.2025.08.062","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Liver transplantation(LT) for unresectable colorectal liver metastases(uCLRM)showed good outcomes in terms of overall survival, and the field is exploding with several trials. We aimed to</div></div><div><h3>Methods</h3><div>A systematic review of the literature was performed to identify ongoing protocols of LT for uCRLM. All trials (both completed and/or with only published protocol) on LT for uCRLM published until May 1, 2025 were included in the analysis. The aims of the study were to identify the inclusion/exclusion criteria for LT in patients with uCRLM and to develop a practical on-line web tool to easy select patients with uCRLM eligible to LT.</div></div><div><h3>Results</h3><div>Out of 27 studies included, 23 (%) studies were still ongoing trials, while 8 (29.6%) trials had already published results. Selection criteria for LT elegibility for patienst with uCRLM were related to patient status, primary cancer, the extent of secondary liver disease, systemic therapy and disease trend. Radical surgery of the primary was required in 52%, while patients could be excluded for inadequate margins(11%), advanced T(22%) or N(19%) staging. Only few protocols excluded patients with primary rectal(7%) or right-colon(4%) locations. Primary cancer-related exclusion criterion were BRAF mutation (in 52% of protocols), microsatellite instability (22%), and RAS (7%). The dimension of hepatic lesions was considered as a selecting criteria in 33% of trials, while the number of hepatic lesions was considered only in 4%. Extrahepatic disease was not admissible in 67%, while 26% of trials accepted resectable lung-lesions. Systemic-therapy was mandatory in 93% of protocols, with stability(67%) or partial-response(11%)required by most. The LT-CLEAR, an on-line intuitive and easy tool was developed intended for consultation by clinicians to define whether patients with uCRLM can be eligible for LT according to the selecting criteria of published trials of LT for uCRLM.</div></div><div><h3>Conclusions</h3><div>YSelection criteria for patients with uCRLM eligible for LT are wildly variable. Due to the increasing number of LT protocols for uCRLM with heterogenous inclusion criteria, selecting patients with uCRLM eligible to LT may be bewildering for clinicians. The LT-CLEAR is a simple tool that help in selecting eligible LT candidate and may prove useful to encourage widespread consideration of LT as a therapy for uCRLM.</div></div>","PeriodicalId":11268,"journal":{"name":"Digestive and Liver Disease","volume":"57 ","pages":"Page S345"},"PeriodicalIF":3.8000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Liver Transplantation for Unresectable Colorectal Liver Metastases: Worldwide Protocol Eligibility Criteria and Development of a Transplant-oriented patient-evaluation Tool (LT-CLEAR)\",\"authors\":\"B. Sensi , R. Angelico , L. Toti , M. Alessi , G. D’arcangelo , J. Bloino , G. Tisone , T.M. Manzia\",\"doi\":\"10.1016/j.dld.2025.08.062\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Liver transplantation(LT) for unresectable colorectal liver metastases(uCLRM)showed good outcomes in terms of overall survival, and the field is exploding with several trials. We aimed to</div></div><div><h3>Methods</h3><div>A systematic review of the literature was performed to identify ongoing protocols of LT for uCRLM. All trials (both completed and/or with only published protocol) on LT for uCRLM published until May 1, 2025 were included in the analysis. The aims of the study were to identify the inclusion/exclusion criteria for LT in patients with uCRLM and to develop a practical on-line web tool to easy select patients with uCRLM eligible to LT.</div></div><div><h3>Results</h3><div>Out of 27 studies included, 23 (%) studies were still ongoing trials, while 8 (29.6%) trials had already published results. Selection criteria for LT elegibility for patienst with uCRLM were related to patient status, primary cancer, the extent of secondary liver disease, systemic therapy and disease trend. Radical surgery of the primary was required in 52%, while patients could be excluded for inadequate margins(11%), advanced T(22%) or N(19%) staging. Only few protocols excluded patients with primary rectal(7%) or right-colon(4%) locations. Primary cancer-related exclusion criterion were BRAF mutation (in 52% of protocols), microsatellite instability (22%), and RAS (7%). The dimension of hepatic lesions was considered as a selecting criteria in 33% of trials, while the number of hepatic lesions was considered only in 4%. Extrahepatic disease was not admissible in 67%, while 26% of trials accepted resectable lung-lesions. Systemic-therapy was mandatory in 93% of protocols, with stability(67%) or partial-response(11%)required by most. The LT-CLEAR, an on-line intuitive and easy tool was developed intended for consultation by clinicians to define whether patients with uCRLM can be eligible for LT according to the selecting criteria of published trials of LT for uCRLM.</div></div><div><h3>Conclusions</h3><div>YSelection criteria for patients with uCRLM eligible for LT are wildly variable. Due to the increasing number of LT protocols for uCRLM with heterogenous inclusion criteria, selecting patients with uCRLM eligible to LT may be bewildering for clinicians. The LT-CLEAR is a simple tool that help in selecting eligible LT candidate and may prove useful to encourage widespread consideration of LT as a therapy for uCRLM.</div></div>\",\"PeriodicalId\":11268,\"journal\":{\"name\":\"Digestive and Liver Disease\",\"volume\":\"57 \",\"pages\":\"Page S345\"},\"PeriodicalIF\":3.8000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Digestive and Liver Disease\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1590865825010436\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"GASTROENTEROLOGY & HEPATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Digestive and Liver Disease","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1590865825010436","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GASTROENTEROLOGY & HEPATOLOGY","Score":null,"Total":0}
Liver Transplantation for Unresectable Colorectal Liver Metastases: Worldwide Protocol Eligibility Criteria and Development of a Transplant-oriented patient-evaluation Tool (LT-CLEAR)
Background
Liver transplantation(LT) for unresectable colorectal liver metastases(uCLRM)showed good outcomes in terms of overall survival, and the field is exploding with several trials. We aimed to
Methods
A systematic review of the literature was performed to identify ongoing protocols of LT for uCRLM. All trials (both completed and/or with only published protocol) on LT for uCRLM published until May 1, 2025 were included in the analysis. The aims of the study were to identify the inclusion/exclusion criteria for LT in patients with uCRLM and to develop a practical on-line web tool to easy select patients with uCRLM eligible to LT.
Results
Out of 27 studies included, 23 (%) studies were still ongoing trials, while 8 (29.6%) trials had already published results. Selection criteria for LT elegibility for patienst with uCRLM were related to patient status, primary cancer, the extent of secondary liver disease, systemic therapy and disease trend. Radical surgery of the primary was required in 52%, while patients could be excluded for inadequate margins(11%), advanced T(22%) or N(19%) staging. Only few protocols excluded patients with primary rectal(7%) or right-colon(4%) locations. Primary cancer-related exclusion criterion were BRAF mutation (in 52% of protocols), microsatellite instability (22%), and RAS (7%). The dimension of hepatic lesions was considered as a selecting criteria in 33% of trials, while the number of hepatic lesions was considered only in 4%. Extrahepatic disease was not admissible in 67%, while 26% of trials accepted resectable lung-lesions. Systemic-therapy was mandatory in 93% of protocols, with stability(67%) or partial-response(11%)required by most. The LT-CLEAR, an on-line intuitive and easy tool was developed intended for consultation by clinicians to define whether patients with uCRLM can be eligible for LT according to the selecting criteria of published trials of LT for uCRLM.
Conclusions
YSelection criteria for patients with uCRLM eligible for LT are wildly variable. Due to the increasing number of LT protocols for uCRLM with heterogenous inclusion criteria, selecting patients with uCRLM eligible to LT may be bewildering for clinicians. The LT-CLEAR is a simple tool that help in selecting eligible LT candidate and may prove useful to encourage widespread consideration of LT as a therapy for uCRLM.
期刊介绍:
Digestive and Liver Disease is an international journal of Gastroenterology and Hepatology. It is the official journal of Italian Association for the Study of the Liver (AISF); Italian Association for the Study of the Pancreas (AISP); Italian Association for Digestive Endoscopy (SIED); Italian Association for Hospital Gastroenterologists and Digestive Endoscopists (AIGO); Italian Society of Gastroenterology (SIGE); Italian Society of Pediatric Gastroenterology and Hepatology (SIGENP) and Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD).
Digestive and Liver Disease publishes papers on basic and clinical research in the field of gastroenterology and hepatology.
Contributions consist of:
Original Papers
Correspondence to the Editor
Editorials, Reviews and Special Articles
Progress Reports
Image of the Month
Congress Proceedings
Symposia and Mini-symposia.