A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma

Cheng, Chao; Xu, Min; Pan, Jinhua; Chen, Qiang; Li, Kai; Xu, Dong; Jing, Xiang; Lu, Qiang; Yang, Hong; Zhao, Qiyu; Deng, Zhuang; Jiang, Tian’an

doi:10.1186/s12957-024-03614-z

Table 1 Follow-up scheme

From: A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma

Trial phase Trial content			a Screening	Follow-up
			Visit 1	Visit 2	Visit 3	Visit 4	Visit 5
			Preoperative (-14 ~ 0d)	Ablation day (0d)	2 ± 1d after first ablation	30 ± 5d after first ablation	Every 3 months after first ablation
Informed consent^b			√
Demographic data			√
History of liver tumors and past medical history			√
Vital signs			√	√	√	√	√
Laboratory examination	Urine pregnancy^c		√
	Routine urine test^d		√
	Routine blood test^e		√		√	√	√
	Stool routine examination^f		√
	Hepatorenal function^g		√		√	√	√
	Serum electrolyte^h		√		√	√	√
	Coagulation functionⁱ		√		√	√	√
	Myocardial enzyme^j		√		√	√	√
	Tumor marker^k		√			√	√
Lung CT scan			√
ECG			√		√	√	√
CEUS			√		√	√	√
Enhanced MRI/CT examination of upper abdomen^l			√			√	√
ECOG			√			√	√
Child-Pugh			√			√	√
Random allocation				√
Ablation				√
Observation of device defects				√
Evaluation of ablation efficacy						√	√
Record combined medication/treatment			√	√	√	√	√
Handle and record adverse events				√	√	√	√
Verify deviation from protocol				√	√	√	√
Immune index in peripheral blood		The proportion of MDSC ^o	√	√	√	√	√
		The proportion of TEMs ^o	√	√	√	√	√
		The concentration of cytokines in serum ^o	√	√	√	√	√
		Tregs^p	√	√	√	√	√
		aTregs^r	√	√	√	√	√
		rTregs^s	√	√	√	√	√

^(a) If the patient has undergone relevant examinations before providing written informed consent and within 14 days before procedure, these data can be collected as data of this clinical trial, and the patient does not need to undergo relevant examinations such as laboratory examination, electrocardiography, and lung CT. The informed process shall be conducted prior to any screening process associated with the trial. ^(b) The informed consent process shall be conducted prior to any screening process related to the trial. ^(c) Women of childbearing age (18–50 years old and >50 years old without amenorrhea) ^(d) Routine urine tests should include at least protein, red blood cell count, and white blood cell count ^(e) Routine blood tests should include at least red blood cell count, white blood cell count, hemoglobin, and platelet count ^(f) Routine stool tests should include at least occult blood test ^(g) Hepatorenal function test should at least include alanine aminotransferase, aspartate aminotransferase, γ−glutamyl transferase, total protein, albumin, total bilirubin, direct bilirubin, blood urea nitrogen or urea, and creatinine ^(h) Serum electrolytes should contain at least the following test items: potassium ion, sodium ion, chloride ion, and calcium ion ⁽ⁱ⁾ Coagulation function tests should at least include the prothrombin time, activated partial thromboplastin time, and international normalized ratio ^(j) The myocardial enzyme spectrum should at least include phosphocreatine kinase, phosphocreatine kinase isoenzyme, and lactate dehydrogenase ^(k) Tumor markers should at least include alpha fetoprotein and carcinoembryonic antigen ^(l) Screening MRI/CT examination can still be used within 30 days ^(m) Only patients whose first tumor ablation result was “incomplete ablation” should undergo a second ablation, which should be completed within 2 weeks after Visit 4. If Visit 4 and Supplementary visit 1 are completed within the same period of admission, these two visits can be combined as one visit. The inspection performed at Visit 4 is not required for Supplementary visit 1. If not completed within the same admission period, the routine blood and coagulation function tests required at Supplementary visit 1 are available within 14 days before procedure. ^(o) These indexes were tested by flow cytometer ^(p) Regulatory T cells ^(q) Activated regulatory T cells ^(r) Resting regulatory T cells CT, computed tomography; ECG, electrocardiography; CEUS, contrast−enhanced ultrasound; MRI, magnetic resonance imaging; CT, computed tomography; ECOG, Eastern Cooperative Oncology Group performance status

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ISSN: 1477-7819

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