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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05462470
• Other study ID #: IU-CRLM
• Status: Completed
• Start date: January 1, 2008
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2022
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

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
Systemic palliative chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	Overall survival after the first resection of liver metastatic lesions	5 years
Secondary	first relapse free survival	relapse free survival after the first resection of liver metastatic lesions	5 years
Secondary	second relapse free survival	relapse free survival after the repeat liver surgery of liver metastatic lesions	5 years
Secondary	Severe complication rate after resection of primary and metastatic lesions	Grade of III-V complication rate according to Clavien-Dindo	30 days after surgery