RECRUITINGINTERVENTIONAL
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis
Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis (HELARC) ------ a Randomized Controlled Multicenter Clinical Study
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. At least one metastatic adenocarcinoma of liver, histologically proven.
2. At least one adenocarcinoma of colon and/or rectum, histologically proven.
3. No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion).
4. No extra-hepatic metastasis.
5. Extra-hepatic disease (EHD) suitable for hepatectomy, liver ablation and anesthesia as long as all sites of EHD disease are radically treated.
6. 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 primary tumor)
7. Residual hepatic volume\>30%-40%.
8. 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.
9. Tumor size ≤3 cm.
10. Tumor number≤ 3.
11. Tumors located ≥1.0 cm of vulnerable structures, e.g. colon, main trunk of portal vein, hepatic artery, hepatic vein and intrahepatic biliary duct.
12. suitable for both hepatectomy and local ablation after multiple disciplinary team(MDT) discussion.
13. Informed written consent.
Who Should NOT Join This Trial:
1. Other malignant tumors history.
2. Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses, et al.).
3. Colorectal or hepatic tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
4. Hepatic lesions diagnosed with ultrasound and MRI making complete ablation impossible immediately.
5. ≤ 2 hepatic segments remained after hepatectomy or residual hepatic volume﹤30%-40%
6. Non resectable lymph node metastasis.
7. American Society of Anesthesiologists(ASA) grading≥ IV and/or Eastern cooperative oncology group(ECOG) score≥ 2. (see appendix)
8. EHD is not recommended.
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Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. At least one metastatic adenocarcinoma of liver, histologically proven.
2. At least one adenocarcinoma of colon and/or rectum, histologically proven.
3. No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion).
4. No extra-hepatic metastasis.
5. Extra-hepatic disease (EHD) suitable for hepatectomy, liver ablation and anesthesia as long as all sites of EHD disease are radically treated.
6. 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 primary tumor)
7. Residual hepatic volume\>30%-40%.
8. 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.
9. Tumor size ≤3 cm.
10. Tumor number≤ 3.
11. Tumors located ≥1.0 cm of vulnerable structures, e.g. colon, main trunk of portal vein, hepatic artery, hepatic vein and intrahepatic biliary duct.
12. suitable for both hepatectomy and local ablation after multiple disciplinary team(MDT) discussion.
13. Informed written consent.
Exclusion Criteria:
1. Other malignant tumors history.
2. Complications need emergency surgery (occlusion, sub-occlusion, massive hemorrhage and abscesses, et al.).
3. Colorectal or hepatic tumor extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately.
4. Hepatic lesions diagnosed with ultrasound and MRI making complete ablation impossible immediately.
5. ≤ 2 hepatic segments remained after hepatectomy or residual hepatic volume﹤30%-40%
6. Non resectable lymph node metastasis.
7. American Society of Anesthesiologists(ASA) grading≥ IV and/or Eastern cooperative oncology group(ECOG) score≥ 2. (see appendix)
8. EHD is not recommended.
9. Physical or psychological dependence.
10. Pregnant or breast feeding women.
11. Not controlled preoperational infection.
12. Enrolled in other clinical trials within 4 weeks. Other clinical or laboratorial condition not recommended by investigators.
Treatments Being Tested
PROCEDURE
CRLM resection group
Simultaneous resection of both primary and secondary tumors in synchronous CRLM or resection of metachronous CRLM.
DEVICE
CRLM ablation group
Microwave ablation of CRLM with a 2.15-gigahertz(GHz) microwave generator and a 14 gauge diameter transcutaneous antenna within 30 days after resection of primary tumor in synchronous CRLM or ablation of metachronous CRLM.
Locations (1)
The 6th Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China