Clinical Trial

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

Recruiting
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Record status
This record was last updated May 6, 2025 (before its estimated April 7, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-16.
Status change: Not Yet Recruiting → Recruiting 2025-05-02
Trial Details
NCT Number NCT06934018
Lead Sponsor Fudan University
Conditions Oncology, Tumor Recurrence and Metastasis
Enrollment 140 participants
Start Date 2025-04-21
Primary Completion 2026-04-07 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-06