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

For patients with initially unresectable colorectal liver metastasis (IU-CRLM) receiving effective conversion therapy, disease relapse after conversion hepatectomy is common due to the extensive tumor load. Yet, few studies have focused on the assessment and management of relapse after conversion hepatectomy for IU-CRLM. This study aimed to investigate the impact of surgical management for relapse after conversion hepatectomy in IU-CRLM.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Liver Metastases
• Intervention / Treatment: Procedure: Repeat Liver Surgery; Procedure: Non-Repeat Liver Surgery

• Study Type: Observational
• Enrollment (Actual): 255

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with initially unresectable colorectal liver metastasis (IU-CRLM) underwent hepatectomy after conversion therapy

Description

Inclusion Criteria:

• initially unresectable colorectal liver metastasis (IU-CRLM)
• received conversion therapy
• underwent conversion hepatectomy

Exclusion Criteria:

• the histologic type of CRLM was not called adenocarcinoma
• uncontrollable extrahepatic metastases, such as peritoneal, bone, brain metastasis
• history of previous hepatectomy
• the primary tumor was not resected or palliative resection
• R1 or R2 liver resection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
repeat liver surgery; repeat liver surgery for liver relapse lesions	Procedure: Repeat Liver Surgery; repeat liver surgery included not only hepatectomy, but also ablative treatment, including radiofrequency ablation (RFA) and microwave ablation (MWA)
non-repeat liver surgery; non-repeat liver surgery, just only systemic palliative chemotherapy	Procedure: Non-Repeat Liver Surgery; Systemic palliative chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	Overall survival after the first resection of liver metastatic lesions	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
first relapse free survival	relapse free survival after the first resection of liver metastatic lesions	5 years
second relapse free survival	relapse free survival after the repeat liver surgery of liver metastatic lesions	5 years
Severe complication rate after resection of primary and metastatic lesions	Grade of III-V complication rate according to Clavien-Dindo	30 days after surgery

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Jianmin Xu, MD, Department of General Surgery, Zhongshan Hospital, Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2008
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ACTUAL): April 30, 2022

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (ACTUAL): July 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 16, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplastic Processes; Neoplasm Metastasis; Liver Neoplasms; Hematinics; Liver Extracts
• Other Study ID Numbers: IU-CRLM