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

Completed

• Conditions: Liver Metastases; Colorectal Cancer
• Interventions: Procedure: Repeat Liver Surgery; Procedure: Non-Repeat Liver Surgery

• Registration Number: NCT05462470
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-07
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-16
• Study First Posted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
repeat liver surgery	Repeat Liver Surgery	repeat liver surgery for liver relapse lesions
non-repeat liver surgery	Non-Repeat Liver Surgery	non-repeat liver surgery, just only systemic palliative chemotherapy

Primary Outcome Measures

Name	Time	Method
overall survival	5 years	Overall survival after the first resection of liver metastatic lesions

Secondary Outcome Measures

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