National Registry of Liver First Approach

NCT04683783 | Completed DMC

• 1 other identifier: PI19/256
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colonic Cancer; Rectal Cancer; Liver Metastases

Keywords

Liver first approach; Reverse strategy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who complete the entire cycle

  Percentage of patients who complete the cycle: neoadjuvant chemotherapy - liver surgery - CT / RT of the primary - surgery of the primary tumor

  90 days

Secondary Outcomes (2)

• Mortality rate

  90 days

• Morbidity rate

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients operated on in the participating Spanish centers with colorectal cancer and synchronous liver metastases who underwent a liver first approach during the study period and that meet the inclusion criteria

You may qualify if:

• 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.

You may not qualify if:

• Patients under 18 year old.
• ASA ≥ IV.
• Urgent surgery.
• Patients who have not signed the informed consent.

Sponsors & Collaborators

• Hospital Miguel Servet: lead
• Spanish Association of Surgeons (AEC): collaborator

Study Sites (1)

Mario Serradilla Martín

Zaragoza, 50008, Spain

Location

Related Publications (12)

• 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.

  PMID: 23715907 RESULT

• 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.

  PMID: 21929676 RESULT

• 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.

  PMID: 23509899 RESULT

• 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.

  PMID: 22778934 RESULT

• 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.

  PMID: 16671066 RESULT

• 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.

  PMID: 23433970 RESULT

• 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.

  PMID: 22962059 RESULT

• 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.

  PMID: 26417845 RESULT

• 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.

  PMID: 26078580 RESULT

• 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.

  PMID: 26085905 RESULT

• 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.

  PMID: 27838252 RESULT

• 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.

  PMID: 28343889 RESULT

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FACS

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: June 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

ES (1)