Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis

NCT02886104 | Recruiting DMC

• 1 other identifier: E2016026
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 1

Brief Summary

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

Secondary Malignant Neoplasm of Liver

Keywords

synchronous; metachronous; colorectal liver metastasis; resection; ablation

Outcome Measures

Primary Outcomes (1)

• Overall survival

  3 years

Secondary Outcomes (5)

• R0 resection rate in both primary and secondary tumor in CRLM

  Day of surgery

• Death rate during hospitalization or within 30 days after surgery/ablation

  30 days after surgery/ablation

• Rate of patients with at least one postoperative severe complication within 30 days after surgery/ablation

  30 days after surgery/ablation

• Disease-free survival and 1, 2 and 3-years disease-free survival rate

  1, 2 and 3-years

• Complete ablation rate in CRLM

  Day of ablation

Study Arms (2)

CRLM resection group

ACTIVE COMPARATOR

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.

Procedure: CRLM resection group

CRLM ablation group

EXPERIMENTAL

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

Interventions

CRLM resection group PROCEDURE

Simultaneous resection of both primary and secondary tumors in synchronous CRLM or resection of metachronous CRLM.

Also known as: Hepatectomy

CRLM resection group

CRLM ablation group DEVICE

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.

Also known as: Microwave ablation

CRLM ablation group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Second Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

The 6th Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Related Publications (5)

• Brody H. Colorectal cancer. Nature. 2015 May 14;521(7551):S1. doi: 10.1038/521S1a. No abstract available.

  PMID: 25970450 BACKGROUND

• Joranger P, Nesbakken A, Hoff G, Sorbye H, Oshaug A, Aas E. Modeling and validating the cost and clinical pathway of colorectal cancer. Med Decis Making. 2015 Feb;35(2):255-65. doi: 10.1177/0272989X14544749. Epub 2014 Jul 29.

  PMID: 25073464 BACKGROUND

• Kopetz S, Chang GJ, Overman MJ, Eng C, Sargent DJ, Larson DW, Grothey A, Vauthey JN, Nagorney DM, McWilliams RR. Improved survival in metastatic colorectal cancer is associated with adoption of hepatic resection and improved chemotherapy. J Clin Oncol. 2009 Aug 1;27(22):3677-83. doi: 10.1200/JCO.2008.20.5278. Epub 2009 May 26.

  PMID: 19470929 BACKGROUND

• Bethke A, Kuhne K, Platzek I, Stroszczynski C. Neoadjuvant treatment of colorectal liver metastases is associated with altered contrast enhancement on computed tomography. Cancer Imaging. 2011 Jun 29;11(1):91-9. doi: 10.1102/1470-7330.2011.0015.

  PMID: 21771709 BACKGROUND

• Livraghi T. Single HCC smaller than 2 cm: surgery or ablation: interventional oncologist's perspective. J Hepatobiliary Pancreat Sci. 2010 Jul;17(4):425-9. doi: 10.1007/s00534-009-0244-x. Epub 2009 Nov 5.

  PMID: 19890600 BACKGROUND

MeSH Terms

Interventions

Hepatectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Meijin Huang, MD,PHD

  The 6th Affiliated Hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meijin Huang, MD,PHD

CONTACT

+8613924073322; maymay0129@139.com

Jun Huang, MD,PHD

CONTACT

+8613926451242; huangj97@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 1, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2021
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

CN (1)