Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis
July 16, 2022 updated by: Xu jianmin, Fudan University
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
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
255
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
repeat liver surgery
repeat liver surgery for liver relapse lesions
|
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
|
Systemic palliative chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
overall survival
Time Frame: 5 years
|
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
Time Frame: 5 years
|
relapse free survival after the first resection of liver metastatic lesions
|
5 years
|
|
second relapse free survival
Time Frame: 5 years
|
relapse free survival after the repeat liver surgery of liver metastatic lesions
|
5 years
|
|
Severe complication rate after resection of primary and metastatic lesions
Time Frame: 30 days after surgery
|
Grade of III-V complication rate according to Clavien-Dindo
|
30 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jianmin Xu, MD, Department of General Surgery, Zhongshan Hospital, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- IU-CRLM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.