Colorectal liver metastases: surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial

被引：176

作者：

Puijk, Robbert S. ^{[1
]}

Ruarus, Alette H. ^{[1
]}

Vroomen, Laurien G. P. H. ^{[1
]}

van Tilborg, Aukje A. J. M. ^{[1
]}

Scheffer, Hester J. ^{[1
]}

Nielsen, Karin ^{[2
]}

de Jong, Marcus C. ^{[1
]}

de Vries, Jan J. J. ^{[1
]}

Zonderhuis, Babs M. ^{[2
]}

Eker, Hasan H. ^{[2
]}

Kazemier, Geert ^{[2
]}

Verheul, Henk ^{[3
]}

van der Meijs, Bram B. ^{[1
]}

van Dam, Laura ^{[1
]}

Sorgedrager, Natasha ^{[1
]}

Coupe, Veerle M. H. ^{[4
]}

van den Tol, Petrousjka M. P. ^{[2
]}

Meijerink, Martijn R. ^{[1
]}

机构：

[1] Univ Amsterdam, Med Ctr, Dept Radiol & Nucl Med, de Boelelaan 1117, NL-1081 HV Amsterdam, Netherlands

[2] Univ Amsterdam, Med Ctr, Dept Surg, de Boelelaan 1117, NL-1081 HV Amsterdam, Netherlands

[3] Univ Amsterdam, Med Ctr, Dept Med Oncol, de Boelelaan 1117, NL-1081 HV Amsterdam, Netherlands

[4] Univ Amsterdam, Med Ctr, Dept Epidemiol & Biostat, de Boelelaan 1117, NL-1081 HV Amsterdam, Netherlands

来源：

BMC CANCER | 2018年 / 18卷

关键词：

Colorectal cancer; Colorectal liver metastases (CRLM); Liver metastases; Hepatic resection; Liver surgery; Thermal ablation; Radiofrequency ablation (RFA); Microwave ablation (MWA); LAPAROSCOPIC RADIOFREQUENCY ABLATION; MICROWAVE COAGULATION THERAPY; HEPATIC RESECTION; SURGICAL RESECTION; TUMOR ABLATION; OUTCOMES; RECURRENCE; CANCER; HEPATECTOMY; TIME;

D O I：

10.1186/s12885-018-4716-8

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Radiofrequency ablation (RFA) and microwave ablation (MWA) are widely accepted techniques to eliminate small unresectable colorectal liver metastases (CRLM). Although previous studies labelled thermal ablation inferior to surgical resection, the apparent selection bias when comparing patients with unresectable disease to surgical candidates, the superior safety profile, and the competitive overall survival results for the more recent reports mandate the setup of a randomized controlled trial. The objective of the COLLISION trial is to prove noninferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable CRLM and no extrahepatic disease. Methods: In this two-arm, single-blind multi-center phase-III clinical trial, six hundred and eighteen patients with at least one CRLM (<= 3 cm) will be included to undergo either surgical resection or thermal ablation of appointed target lesion(s) (<= 3 cm). Primary endpoint is OS (overall survival, intention-to-treat analysis). Main secondary endpoints are overall disease-free survival (DFS), time to progression (TTP), time to local progression (TTLP), primary and assisted technique efficacy (PTE, ATE), procedural morbidity and mortality, length of hospital stay, assessment of pain and quality of life (QoL), cost-effectiveness ratio (ICER) and quality-adjusted life years (QALY). Discussion: If thermal ablation proves to be non-inferior in treating lesions <= 3 cm, a switch in treatment-method may lead to a reduction of the post-procedural morbidity and mortality, length of hospital stay and incremental costs without compromising oncological outcome for patients with CRLM.

引用

页数：13

共 67 条

[1]

Abdalla EK, 2004, ANN SURG, V239, P818, DOI 10.1097/01.sla.0000128305.90650.71

[2] Complementary Use of Resection and Radiofrequency Ablation for the Treatment of Colorectal Liver Metastases: An Analysis of 395 Patients [J].