Anatomical Resection VS. Nonanatomical Resection for Colorectal Liver Metastases With Gene Mutation or Right-sidedness

Not Applicable

Not yet recruiting

• Conditions: Colorectal Carcinoma; Liver Metastases
• Interventions: Procedure: anatomical liver resection; Procedure: nonanatomical liver resection

• Registration Number: NCT05881746
• Lead Sponsor: Fudan University

Brief Summary

In this study, colorectal cancer patients with initially resectable liver-only metastases, as prospectively confirmed by a local multidisciplinary team (MDT) according to predefined criteria, will be tested for RAS and BRAF tumor mutation status. Patients with gene mutant or right-sidedness will be randomised between anatomical resection (AR) or nonanatomical resection (NAR). The primary end-point is the relapse-free survival.

Detailed Description

This study is a prospective, single-center, randomized control trial. The major including criteria are (1) Histologically confirmed colorectal cancer initially resectable liver-only metastases ; (2) patient has the opportunity to perform either anatomical resection (AR) or nonanatomical resection (NAR) surgery; (3) the number of metastasis is 1-3; (4) KRAS/NRAS/BRAF mutation or right-sidedness. Patients will be randomised between AR or NAR. Patients will be stratified for gene mutation and right-sidedness.

Based upon the segmental anatomy of the liver according to Couinaud system, AR is defined as the resection of one or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination thereof. NAR, also called as wedge resection, is defined as the resection of the tumor with a margin of normal parenchyma regardless of the hepatic anatomy.

The primary end-point is the relapse-free survival. The secondary end-points are postoperative complication, postoperative mortality, hospital length of stay, and overall survival.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-21
• Last Update Submitted: 2023-05-21
• Study First Posted: 2023-05-31
• Last Update Posted: 2023-05-31
• Study Start: 2023-07-01
• Primary Completion: 2026-07-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1. Age ≥ 18 and ≤ 75 years;
2. Histological proof of colorectal adenocarcinoma;
3. Resectable colorectal liver metastasis without detectable extrahepatic distant metastatic disease (determined by a local MDT);
4. Suitable for anatomical or nonanatomical liver resection (determined by a local MDT);
5. Number of metastasis is 1 to 3;
6. KRAS/NRAS/BRAF mutation or right-sidedness;
7. Performance Status (ECOG) 0~1;
8. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization);
9. Adequate liver and renal function: total bilirubin ≤2.0 mg/dl, serum transaminases ≤ 5x upper limit of normal(ULN), and serum creatinine ≤ 1.5x ULN and creatinine clearance ≥ 30 ml/min;
10. Written informed consent.

Exclusion Criteria

1. Previous systemic treatment for metastatic disease;
2. Previous surgery for metastatic disease;
3. Extrahepatic metastases;
4. Unresectable primary tumor;
5. Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
6. Second primary malignancy within the past 5 years;
7. Acute or subacute intestinal obstruction;
8. Drug or alcohol abuse;
9. No legal capacity or limited legal capacity;
10. Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
anatomical resection group	anatomical liver resection	Based upon the segmental anatomy of the liver according to Couinaud system, anatomical resection (AR) is defined as the resection of one or more complete hepatic segments in our study, including bisegmentectomy, right hemihepatectomy, left hemihepatectomy, extended right hemihepatectomy, extended left hemihepatectomy, single segmentectomy, caudate lobectomy, or a combination thereof.
nonanatomical resection group	nonanatomical liver resection	nonanatomical resection (NAR), also called as wedge resection, is defined as the resection of the tumor with a margin of normal parenchyma regardless of the hepatic anatomy.

Primary Outcome Measures

Name	Time	Method
relapse-free survival	3 years	The relapse-free survival (PFS) was defined as the period from the start of initial liver resection to the date of tumor relapse or death

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years	The overall survival (OS) was defined as the period from the start of initial liver resection until death from any cause, at which point the data was censored.
postoperative complication	After surgery during one month	Patients will be evaluated for surgical morbidity during 1 month. Postoperative morbidity will be scored according 'Clavien-Dindo Grade'.
postoperative mortality	After surgery during 90 days	any death occured within 90 days after the last resection of primary and metastatic lesions
postoperative hospital stay	30 days post operatively	The postoperative hospital stay is defined as the number of date from the first day after operation to discharge.

Trial Locations

Locations (1)

Zhongshan hospital; 🇨🇳 Shanghai, Shanghai, China