Effect of Surgical Margin Width on Recurrence and Survival in Patients With Hepatic Oligometastasis of Colorectal Cancer

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

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-21

Study Completion Date

2028-04-30

Brief Summary

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

The main objective of this study was to evaluate the effect of surgical margin width on the prognosis of patients with hepatic oligometastasis of colorectal cancer by statistical 1-year intrahepatic recurrence-free survival rate (ihRFSrate). The secondary objective of the study was to evaluate the effect of surgical margin width on long-term survival and total recurrence of colorectal cancer in patients with hepatohepatic metastasis by statistical overall survival time (OS) and relapse-free survival time (RFS), and to evaluate the safety of wide margin surgery compared with narrow margin surgery in patients with Cromitis during perioperative period.

This was a single-center, prospective, randomized controlled clinical study to evaluate the effects of surgical margin width on 1-year intrahepatic relapse-free survival, relapse-free survival time, overall survival time, and perioperative safety in patients with hepatic oligometastasis of colorectal cancer. Subjects will undergo radical resection of liver tumors and will be randomly assigned to a wide margin group (≥7mm) or narrow margin group (\<7mm) using stratified randomization, stratified by primary lesion site (right colon vs left colon/rectum). The margin width was the narrowest margin distance measured in fresh specimens. After radical liver tumor resection, subjects were pretreated regularly Follow-up evaluation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis

NCT05462470

Colorectal Cancer Liver Metastases

COMPLETED

Impact de la Marge de résection Sur la Survie à Long Terme et le Taux de récidive Des Patients Atteints de Cancers Colorectaux opérés au CHUS Entre 2006 et 2016 Pour Des métastases hépatiques

NCT05164419

Colorectal Cancer Stage IV

COMPLETED

Minimally Invasive Versus Open Surgery for PHC

NCT05402618

Perihilar Cholangiocarcinoma

COMPLETED

Survival Analysis of Surgical Resection Versus Observation in Patients With Initially uHCC Achieving CR After Systemic Therapy

NCT07290764

Hepatocellular Carcinoma

ENROLLING_BY_INVITATION

Influence of Neoadjuvant Therapy on the Resectability of Hepatic Metastases From Colorectal Cancers

NCT00172159

Colorectal Cancer

UNKNOWN PHASE2

Detailed Description

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

Conditions

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

Oncology Tumor Recurrence and Metastasis

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

The surgical margin width was greater than or equal to 7mm

Group Type EXPERIMENTAL

Surgery and procedure

Intervention Type PROCEDURE

Combined with intraoperative B-ultrasound guidance, 3D reconstruction and intraoperative navigation, the surgical margin width of metastatic tumor was greater than or equal to 7mm

Control group

The surgical margin width was less than 7mm

Group Type EXPERIMENTAL

Surgery and procedure

Intervention Type PROCEDURE

According to the "Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Liver metastases of Colorectal Cancer (2023 edition)", R0 resection of metastatic tumors is satisfied, and the objective is to preserve sufficient functional liver tissue, and the surgical margin width is less than 7mm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgery and procedure

According to the "Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Liver metastases of Colorectal Cancer (2023 edition)", R0 resection of metastatic tumors is satisfied, and the objective is to preserve sufficient functional liver tissue, and the surgical margin width is less than 7mm

Intervention Type PROCEDURE

Surgery and procedure

Combined with intraoperative B-ultrasound guidance, 3D reconstruction and intraoperative navigation, the surgical margin width of metastatic tumor was greater than or equal to 7mm

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Male or female patients, age ≥18 years;
* ECOG Physical condition score :0-1 score;
* Liver biopsy pathologic diagnosis or clinical history combined with laboratory examination and imaging findings can be used to diagnose colorectal cancer in liver;
* The primary lesion of colorectal cancer has been resected or can be resected 4-6 weeks after hepatectomy;
* The number of liver metastases was less than or equal to 5；
* There was no extrahepatic metastases or the metastases were radically resected；
* Preoperative assessment (based on enhanced CT or MRI image AI segmentation combined with three-dimensional reconstruction of hepatic parenchymal blood vessels) enables radical (R0) resection of hepatic oligometastases, and wide surgical margin (the narrowest incisal margin of fresh specimens surgically removed is greater than or equal to 7mm) can be achieved technically, and the incisal margin width is not affected by the intrahepatic vasculature；
* Good liver reserve function (preoperative Child-Pugh grade A liver function, estimated remaining liver volume ≥30%)；
* Preoperative examinations do not show clear surgical contraindications；
* Volunteer to participate in this study and sign the informed consent；
* The compliance was good, and the family members were willing to cooperate with the follow-up；

Exclusion Criteria

* There are still untreated extra-hepatic metastases；
* Staging hepatectomy is planned, such as PVE combined with hepatectomy, ALPPS, etc；
* The number of liver metastases before chemotherapy was more than 5；
* Complicated with portal vein tumor thrombus or hepatic vein invasion；
* Concurrent with other uncured malignancies or with other primary malignancies for less than 5 years；
* Expected survival time ≤6 months；
* Those who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders；
* Have a history of immunodeficiency or other acquired or congenital immunodeficiency diseases; Or have an autoimmune disease；
* According to the study, there are serious concomitant diseases that endanger the patient's safety or interfere with the patient's completion of the study；
* Patients or family members could not understand the conditions and goals of the study；

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No