Clinical trial · Observational
National Registry of Liver First Approach
RENACI Project: National Registry of Liver First Approach
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Liver metastases are present in 15-25% of patients with colorectal cancer at the time of diagnosis of the primary tumor, which is defined as synchronous liver metastases. Treatment for the potential cure of this disease includes surgical resection of both the primary tumor and liver metastases. The liver first approach was described by Mentha for patients with asymptomatic rectal tumors with with initially unresectable or borderline resectable liver metastases. There is little data in the scientific literature on how many patients scheduled for this strategy complete both surgeries and/or undergo the full chemo/radiation therapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Cancer | — | UNRESOLVED | — |
| Liver Metastases | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of patients who complete the entire cycle
- timeFrame
- 90 days
- description
- Percentage of patients who complete the cycle: neoadjuvant chemotherapy - liver surgery - CT / RT of the primary - surgery of the primary tumor
Secondary outcomes (2)
- measure
- Mortality rate
- timeFrame
- 90 days
- description
- Postoperative mortality including liver surgery and primary tumor
- measure
- Morbidity rate
- timeFrame
- 90 days
- description
- Postoperative morbidity including liver surgery and primary tumor (all type of postoperative complications)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 year old. * Scheduled surgery for colorectal cancer with synchronous liver metastases using the liver first approach. * ASA score I-III. * They have signed the informed consent. Exclusion Criteria: * Patients under 18 year old. * ASA ≥ IV. * Urgent surgery. * Patients who have not signed the informed consent.
References
Publications (12)
- RESULTJegatheeswaran S, Mason JM, Hancock HC, Siriwardena AK. The liver-first approach to the management of colorectal cancer with synchronous hepatic metastases: a systematic review. JAMA Surg. 2013 Apr;148(4):385-91. doi: 10.1001/jamasurg.2013.1216. PMID 23715907
- RESULTde Jong MC, van Dam RM, Maas M, Bemelmans MH, Olde Damink SW, Beets GL, Dejong CH. The liver-first approach for synchronous colorectal liver metastasis: a 5-year single-centre experience. HPB (Oxford). 2011 Oct;13(10):745-52. doi: 10.1111/j.1477-2574.2011.00372.x. Epub 2011 Sep 5. PMID 21929676
- RESULTLam VW, Laurence JM, Pang T, Johnston E, Hollands MJ, Pleass HC, Richardson AJ. A systematic review of a liver-first approach in patients with colorectal cancer and synchronous colorectal liver metastases. HPB (Oxford). 2014 Feb;16(2):101-8. doi: 10.1111/hpb.12083. Epub 2013 Mar 19. PMID 23509899
- RESULTTsoulfas G, Pramateftakis MG. Management of rectal cancer and liver metastatic disease: which comes first? Int J Surg Oncol. 2012;2012:196908. doi: 10.1155/2012/196908. Epub 2012 Jun 20. PMID 22778934
- RESULTMentha G, Majno PE, Andres A, Rubbia-Brandt L, Morel P, Roth AD. Neoadjuvant chemotherapy and resection of advanced synchronous liver metastases before treatment of the colorectal primary. Br J Surg. 2006 Jul;93(7):872-8. doi: 10.1002/bjs.5346. PMID 16671066
- RESULTMayo SC, Pulitano C, Marques H, Lamelas J, Wolfgang CL, de Saussure W, Choti MA, Gindrat I, Aldrighetti L, Barrosso E, Mentha G, Pawlik TM. Surgical management of patients with synchronous colorectal liver metastasis: a multicenter international analysis. J Am Coll Surg. 2013 Apr;216(4):707-16; discussion 716-8. doi: 10.1016/j.jamcollsurg.2012.12.029. Epub 2013 Feb 21. PMID 23433970
- RESULTAdam R, De Gramont A, Figueras J, Guthrie A, Kokudo N, Kunstlinger F, Loyer E, Poston G, Rougier P, Rubbia-Brandt L, Sobrero A, Tabernero J, Teh C, Van Cutsem E; Jean-Nicolas Vauthey of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastases) group. The oncosurgery approach to managing liver metastases from colorectal cancer: a multidisciplinary international consensus. Oncologist. 2012;17(10):1225-39. doi: 10.1634/theoncologist.2012-0121. Epub 2012 Sep 7.