National Registry of Liver First Approach (RENACI)

December 21, 2020 updated by: Mario Serradilla, MD, FACS, Hospital Miguel Servet

RENACI Project: National Registry of Liver First Approach

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

168

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50008
        • Mario Serradilla Martín

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients who complete the entire cycle
Time Frame: 90 days
Percentage of patients who complete the cycle: neoadjuvant chemotherapy - liver surgery - CT / RT of the primary - surgery of the primary tumor
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 90 days
Postoperative mortality including liver surgery and primary tumor
90 days
Morbidity rate
Time Frame: 90 days
Postoperative morbidity including liver surgery and primary tumor (all type of postoperative complications)
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Miguel Servet

Collaborators

Spanish Association of Surgeons (AEC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 21, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 21, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI19/256

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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