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New treatment option for Secondary Malignant Neoplasm of Liver
Official title Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis
ClinicalTrials.gov ID: NCT02886104
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- At least one metastatic adenocarcinoma of liver, histologically proven.
- At least one adenocarcinoma of colon and/or rectum, histologically proven.
- No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion).
- No extra-hepatic metastasis.
- Extra-hepatic disease (EHD) suitable for hepatectomy, liver ablation and anesthesia as long as all sites of EHD disease are radically treated.
You likely can't join if
- Other malignant tumors history.
- Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses, et al.).
- Colorectal or hepatic tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
- Hepatic lesions diagnosed with ultrasound and MRI making complete ablation impossible immediately.
- ≤ 2 hepatic segments remained after hepatectomy or residual hepatic volume﹤30%-40%
- Non resectable lymph node metastasis.
See the full eligibility criteria
- At least one metastatic adenocarcinoma of liver, histologically proven.
- At least one adenocarcinoma of colon and/or rectum, histologically proven.
- No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion).
- No extra-hepatic metastasis.
- Extra-hepatic disease (EHD) suitable for hepatectomy, liver ablation and anesthesia as long as all sites of EHD disease are radically treated.
- All the primary and secondary tumors which R0 resections are technically possible. (SCRLM: synchronous resection for both primary and secondary tumors, MCRLM: no local recurrence within 6 months after resection of...
- Residual hepatic volume\>30%-40%.
- At least 2-3 hepatic segments remained after hepatectomy (except S1), residual liver with normal portal vein, hepatic artery and biliary duct, at least 1 of hepatic veins (left, middle and right) not invaded.
- Tumor size ≤3 cm.
- Tumor number≤ 3.
- Tumors located ≥1.0 cm of vulnerable structures, e.g. colon, main trunk of portal vein, hepatic artery, hepatic vein and intrahepatic biliary duct.
- suitable for both hepatectomy and local ablation after multiple disciplinary team(MDT) discussion.
- Informed written consent.
- Other malignant tumors history.
- Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses, et al.).
- Colorectal or hepatic tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
- Hepatic lesions diagnosed with ultrasound and MRI making complete ablation impossible immediately.
- ≤ 2 hepatic segments remained after hepatectomy or residual hepatic volume﹤30%-40%
- Non resectable lymph node metastasis.
- American Society of Anesthesiologists(ASA) grading≥ IV and/or Eastern cooperative oncology group(ECOG) score≥ 2. (see appendix)
- EHD is not recommended.
- Physical or psychological dependence.
- Pregnant or breast feeding women.
- Not controlled preoperational infection.
- Enrolled in other clinical trials within 4 weeks. Other clinical or laboratorial condition not recommended by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.