MedDataX Logo

National Registry of Liver First Approach

NCT ID: NCT04683783

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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. However, due to the comorbidity or extent of the tumor disease, only a minority of patients are candidates for curative resections. When surgical treatment is indicated, different strategies can be used. In the classic strategy, the primary tumor is resected first, followed by surgery for metastases and, after that, adjuvant chemotherapy. More recently, simultaneous resection of primary and liver lesions has been used, mainly for limited liver disease without the need for large-volume liver resections. A third option is preoperative chemotherapy, followed by resection of liver metastases and surgery of the primary tumor in a second stage. This technique was initially described in 2006 by Mentha for patients with asymptomatic rectal tumors with initially unresectable or borderline resectable liver metastases. These patients were treated with neoadjuvant chemotherapy, followed by surgery for liver metastases, chemo/radiotherapy of the primary tumor, and second stage surgery. This is what is called surgery or reverse strategy (liver first approach in the Anglo-Saxon world). This strategy has the potential advantage of allowing resection of advanced liver disease in patients when the primary tumor is asymptomatic. Advanced liver disease is the leading cause of mortality in these patients. Subsequently, this strategy has been used in colorectal tumors of any location with synchronous metastases. No clear advantage or disadvantage has been demonstrated with any of the three strategies in terms of long-term survival. There is also no prospective randomized clinical trial comparing classical with reverse strategy.

Most of the previous studies that evaluated this strategy only included patients with liver resection, not the primary one. Therefore, 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. The potential advantage of this strategy is the possibility of rescuing more patients with colorectal cancer liver metastases, thus increasing survival.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonic Cancer Rectal Cancer Liver Metastases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Liver first approach Reverse strategy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Spanish Association of Surgeons (AEC)

OTHER

Sponsor Role collaborator

Hospital Miguel Servet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mario Serradilla, MD, FACS

MD, FACS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mario Serradilla Martín

Zaragoza, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Jegatheeswaran 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.

Reference Type RESULT
PMID: 23715907 (View on PubMed)

de 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.

Reference Type RESULT
PMID: 21929676 (View on PubMed)

Lam 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.

Reference Type RESULT
PMID: 23509899 (View on PubMed)

Tsoulfas 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.

Reference Type RESULT
PMID: 22778934 (View on PubMed)

Mentha 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.

Reference Type RESULT
PMID: 16671066 (View on PubMed)

Mayo 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.

Reference Type RESULT
PMID: 23433970 (View on PubMed)

Adam 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.

Reference Type RESULT
PMID: 22962059 (View on PubMed)

Adam R, de Gramont A, Figueras J, Kokudo N, Kunstlinger F, Loyer E, Poston G, Rougier P, Rubbia-Brandt L, Sobrero A, Teh C, Tejpar S, Van Cutsem E, Vauthey JN, Pahlman L; of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastases) group. Managing synchronous liver metastases from colorectal cancer: a multidisciplinary international consensus. Cancer Treat Rev. 2015 Nov;41(9):729-41. doi: 10.1016/j.ctrv.2015.06.006. Epub 2015 Jun 30.

Reference Type RESULT
PMID: 26417845 (View on PubMed)

Ihnat P, Vavra P, Zonca P. Treatment strategies for colorectal carcinoma with synchronous liver metastases: Which way to go? World J Gastroenterol. 2015 Jun 14;21(22):7014-21. doi: 10.3748/wjg.v21.i22.7014.

Reference Type RESULT
PMID: 26078580 (View on PubMed)

Waisberg J, Ivankovics IG. Liver-first approach of colorectal cancer with synchronous hepatic metastases: A reverse strategy. World J Hepatol. 2015 Jun 18;7(11):1444-9. doi: 10.4254/wjh.v7.i11.1444.

Reference Type RESULT
PMID: 26085905 (View on PubMed)

Sturesson C, Valdimarsson VT, Blomstrand E, Eriksson S, Nilsson JH, Syk I, Lindell G. Liver-first strategy for synchronous colorectal liver metastases - an intention-to-treat analysis. HPB (Oxford). 2017 Jan;19(1):52-58. doi: 10.1016/j.hpb.2016.10.005. Epub 2016 Nov 9.

Reference Type RESULT
PMID: 27838252 (View on PubMed)

Regimbeau JM, Cosse C, Kaiser G, Hubert C, Laurent C, Lapointe R, Isoniemi H, Adam R. Feasibility, safety and efficacy of two-stage hepatectomy for bilobar liver metastases of colorectal cancer: a LiverMetSurvey analysis. HPB (Oxford). 2017 May;19(5):396-405. doi: 10.1016/j.hpb.2017.01.008. Epub 2017 Mar 23.

Reference Type RESULT
PMID: 28343889 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI19/256

Identifier Type: -

Identifier Source: org_study_id