Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis
1 other identifier
observational
255
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2008
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedFirst Submitted
Initial submission to the registry
July 14, 2022
CompletedFirst Posted
Study publicly available on registry
July 18, 2022
CompletedJuly 19, 2022
July 1, 2022
14.3 years
July 14, 2022
July 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
overall survival
Overall survival after the first resection of liver metastatic lesions
5 years
Secondary Outcomes (3)
first relapse free survival
5 years
second relapse free survival
5 years
Severe complication rate after resection of primary and metastatic lesions
30 days after surgery
Study Arms (2)
repeat liver surgery
repeat liver surgery for liver relapse lesions
non-repeat liver surgery
non-repeat liver surgery, just only systemic palliative chemotherapy
Interventions
repeat liver surgery included not only hepatectomy, but also ablative treatment, including radiofrequency ablation (RFA) and microwave ablation (MWA)
Eligibility Criteria
patients with initially unresectable colorectal liver metastasis (IU-CRLM) underwent hepatectomy after conversion therapy
You may qualify if:
- initially unresectable colorectal liver metastasis (IU-CRLM)
- received conversion therapy
- underwent conversion hepatectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianmin Xu, MD
Department of General Surgery, Zhongshan Hospital, Fudan University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy director of the department of general surgery
Study Record Dates
First Submitted
July 14, 2022
First Posted
July 18, 2022
Study Start
January 1, 2008
Primary Completion
April 30, 2022
Study Completion
April 30, 2022
Last Updated
July 19, 2022
Record last verified: 2022-07