Actively Recruiting
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2016-09-01
548
Participants Needed
1
Research Sites
517 weeks
Total Duration
On this page
Sponsors
S
Sixth Affiliated Hospital, Sun Yat-sen University
Lead Sponsor
F
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The surgical and local ablation strategy for the treatment of resectable synchronous and metachronous colorectal liver metastases(CRLM) has not still been defined. The purpose of this study is to compare two treatment strategies in which simultaneous resection of both primary and secondary tumor of synchronous CRLM(SCRLM) and resection of metachronous CRLM(MCRLM) is compared with resection of primary tumor and ablation of secondary tumor in SCRLM and ablation of MCRLM. Endpoints include the rate of severe complications and survival.
CONDITIONS
Official Title
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least one metastatic adenocarcinoma of liver confirmed by tissue analysis
- At least one adenocarcinoma of colon and/or rectum confirmed by tissue analysis
- No local complications at time of surgery such as occlusion, sub-occlusion, massive bleeding, abscesses, or local invasion
- No extra-hepatic metastasis unless all are suitable for radical treatment
- All primary and secondary tumors can be completely removed with surgery (R0 resection) or ablated
- Residual liver volume after surgery is more than 30%-40%
- At least 2-3 liver segments remain after surgery with normal blood vessels and bile ducts
- Tumor size is 3 cm or smaller
- Number of tumors is 3 or fewer
- Tumors are located at least 1.0 cm away from sensitive structures like colon, main vessels, and bile ducts
- Suitable for both hepatectomy and local ablation after expert team discussion
- Provided written informed consent
You will not qualify if you...
- History of other malignant tumors
- Complications requiring emergency surgery such as occlusion, massive bleeding, or abscesses
- Tumor spread making complete liver resection impossible immediately
- Liver lesions unsuitable for complete ablation
- Less than 2 liver segments remain after surgery or residual liver volume below 30%-40%
- Non-resectable lymph node metastases
- Poor health status with ASA score IV or higher, or ECOG score 2 or higher
- Extra-hepatic disease not suitable for treatment
- Physical or psychological dependence
- Pregnant or breastfeeding women
- Uncontrolled infection before surgery
- Participation in other clinical trials within 4 weeks
- Other medical or laboratory conditions not recommended by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The 6th Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
M
Meijin Huang, MD,PHD
CONTACT
J
Jun Huang, MD,PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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