Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis (HELARC)
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ClinicalTrials.gov Identifier: NCT02886104 |
Recruitment Status :
Recruiting
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Secondary Malignant Neoplasm of Liver | Procedure: CRLM resection group Device: CRLM ablation group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 548 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis (HELARC) ------ a Randomized Controlled Multicenter Clinical Study |
Study Start Date : | August 2016 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | July 2026 |
Arm | Intervention/treatment |
---|---|
Active Comparator: CRLM resection group
Resection of both primary and secondary tumors in SCRLM and resection of MCRLM. Interventions: Simultaneous resection of both primary and secondary tumors in SCRLM and resection of MCRLM.
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Procedure: CRLM resection group
Simultaneous resection of both primary and secondary tumors in synchronous CRLM or resection of metachronous CRLM.
Other Name: Hepatectomy |
Experimental: CRLM ablation group
Ablation of CRLM after resection of primary tumor in SCRLM and ablation of MCRLM. Interventions: Ablation of liver metastasis within 30 days after resection of primary tumor in SCRLM and ablation of MCRLM. |
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.
Other Name: Microwave ablation |
- Overall survival [ Time Frame: 3 years ]
- R0 resection rate in both primary and secondary tumor in CRLM [ Time Frame: Day of surgery ]
- Death rate during hospitalization or within 30 days after surgery/ablation [ Time Frame: 30 days after surgery/ablation ]
- Rate of patients with at least one postoperative severe complication within 30 days after surgery/ablation [ Time Frame: 30 days after surgery/ablation ]
- Disease-free survival and 1, 2 and 3-years disease-free survival rate [ Time Frame: 1, 2 and 3-years ]
- Complete ablation rate in CRLM [ Time Frame: Day of ablation ]
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion 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 primary tumor)
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02886104
Contact: Meijin Huang, MD,PHD | +8613924073322 | maymay0129@139.com | |
Contact: Jun Huang, MD,PHD | +8613926451242 | huangj97@mail.sysu.edu.cn |
China, Guangdong | |
The 6th Affiliated Hospital of Sun Yat-Sen University | Recruiting |
Guangzhou, Guangdong, China, 510655 | |
Contact: Meijin Huang, MD,PHD +8613924073322 maymay0129@139.com | |
Contact: Jun Huang, MD,PHD +8613926451242 huangj97@mail.sysu.edu.cn |
Principal Investigator: | Meijin Huang, MD,PHD | The 6th Affiliated Hospital of Sun Yat-sen University |
Responsible Party: | Sixth Affiliated Hospital, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT02886104 |
Other Study ID Numbers: |
E2016026 |
First Posted: | September 1, 2016 Key Record Dates |
Last Update Posted: | September 1, 2016 |
Last Verified: | August 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
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