Administrative information
Title {1} | Chemoembolization Combined Radiofrequency Ablation vs. Chemoembolization Alone for Treatment of beyond the Milan Criteria viable Hepatocellular Carcinoma (CERFA): Study protocol for a randomized controlled trial |
Trial registration {2a and 2b} | Registry: Clinical Research Information Service (CRiS) (https://cris.nih.go.kr/cris) Identifier: KCT0006483 Date of Registry: August 20, 2021 |
Protocol version {3} | Version 2.1, November 15, 2022 |
Funding {4} | 1.The National Research Foundation of Korea (NRF) grant funded by the Korean government (MSIT, no. NRF-2021R1G1A1010823) 2.The Korean Society of Radiology through Radiology Imaging Network of Korea for Clinical Research (RINK-CR-2021–002) 3.STARmed Co., Ltd., Goyang-si, Gyeonggi-do, Korea 4.A Radiological Research Fund of Department of Radiology, The Catholic University of Korea for 2021 |
Author details {5a} | 1Soon Kyu Lee, 2Hyun Yang, 1Jung Hyun Kwon*, 3Dong Jae Shim*, 3Doyoung Kim, 1Soon Woo Nam, 1Sun Hong Yoo, 2Si Hyun Bae, 2Ahlim Lee, 4Young Joon Lee, 4Changho Jeon, 5Jeong Won Jang, 5Pil Soo Sung, 6Ho Jong Chun, 6Su Ho Kim, 6Joon-Il Choi, 6Jung Suk Oh, 7Yun-Jung Yang Department of 1Internal Medicine and 3Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea Department of 2Internal Medicine and 4Radiology, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea Department of 5Internal Medicine and 6Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea 7Institute of Biomedical Science, Catholic Kwandong University International St. Mary’s Hospital, Incheon, Korea SKL and HY contributed equally to this work and are co-first authors. *Correspondence to Dong Jae Shim or Jung Hyun Kwon |
Name and contact information for the trial sponsor {5b} | Dong Jae Shim, MD, PhD inharad@naver.com 56 Dongsu-ro, Bupyeong-gu, Incheon, Republic of Korea, 21431 Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea |
Role of sponsor {5c} | All sponsors supported this study through grants. None of the funders had roles in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion criteria
Exclusion criteria
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Before allocation
Allocation
After allocation
Follow-up and primary endpoint evaluation
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Participant timeline {13}
Study period
| ||||||||
---|---|---|---|---|---|---|---|---|
Enrolment
|
Allocation
|
Post-allocation
|
Close-out
| |||||
Timepoint**
|
-1 to -2 w
|
0
|
2 w
|
1 m
|
2 m
|
6 m
|
12 m
|
24 m
|
Enrolment:
| ||||||||
Eligibility screen
| X | |||||||
Informed consent
| X | |||||||
Laboratory tests
| X | |||||||
Allocation
| X | |||||||
Interventions:
| ||||||||
TACE + RFA
| X | |||||||
TACE
| X | |||||||
Assessments:
| ||||||||
Baseline MRI
| X | |||||||
CT after first TACE
| X | |||||||
Follow-up MRI
| X | |||||||
Regular follow-up (lab, CT or MRI)
| X | X | X | X |