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

• Sponsor: Fudan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05462470
• Collaborator: (none)
• Enrollment: 255
• Actual Duration (Months): 171.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Liver Metastases	Procedure: Repeat Liver Surgery; Procedure: Non-Repeat Liver Surgery

Study Design

• Study Type: Observational
• Actual Enrollment: 255 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis
• Actual Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Apr 30, 2022
• Actual Study Completion Date: Apr 30, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. overall survival [5 years]

   Overall survival after the first resection of liver metastatic lesions

Secondary Outcome Measures

1. first relapse free survival [5 years]

   relapse free survival after the first resection of liver metastatic lesions

2. second relapse free survival [5 years]

   relapse free survival after the repeat liver surgery of liver metastatic lesions

3. Severe complication rate after resection of primary and metastatic lesions [30 days after surgery]

   Grade of III-V complication rate according to Clavien-Dindo

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fudan University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xu jianmin, Deputy director of the department of general surgery, Fudan University
• ClinicalTrials.gov Identifier: NCT05462470
• Other Study ID Numbers: IU-CRLM
• First Posted: Jul 18, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Additional relevant MeSH terms: Neoplasm Metastasis; Liver Neoplasms; Liver Extracts

Study Results

No Results Posted as of Jul 19, 2022