Study on the safety of minimally invasive liver resection guided by a novel multi-source image dynamic navigation system for primary liver cancer: A single-center, single-arm clinical trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400083258

Enrollment

Unknown

Registered

2024-04-19

Start date

2024-05-01

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary liver cancer

Interventions

Experimental group:Real-time interactive visual guidance for minimally invasive liver resection using a novel multi-source image dynamic navigation system

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-75 years; (2) Clinical diagnosis of primary liver cancer; (3) Liver function classified as Child-Pugh grade A or B; (4) Preoperative assessment stage Ia to IIa according to CNLC staging; (5) Scheduled to undergo minimally invasive hepatectomy; (6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; (7) American Society of Anesthesiologists (ASA) classification of I, II, or III; (8) Subjects willing to participate in this study and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women; (2) Severe mental disorders; (3) History of previous upper abdominal surgery (excluding laparoscopic cholecystectomy); (4) History of other malignant diseases within the past 5 years; (5) History of neoadjuvant chemotherapy, radiotherapy, radiofrequency/microwave ablation, targeted therapy, or immunotherapy; (6) History of unstable angina or myocardial infarction within the past 6 months; (7) History of cerebrovascular accidents within the past 6 months; (8) Continuous systemic use of glucocorticoids within the past 1 month; (9) Preoperative imaging examination revealed or intraoperatively discovered cancer thrombi in the main trunk and branches of the portal vein, hepatic duct and branches, main trunk and branches of the hepatic vein, and inferior vena cava; (10) Simultaneous requirement for surgery for other diseases (excluding laparoscopic cholecystectomy); (11) Emergency surgery for complications (bleeding, shock) caused by the rupture of liver cancer; (12) FEV1 less than 50% of predicted value.

Design outcomes

Primary

Measure	Time frame
Liver navigation contour projection error;Intraoperative surface reconstruction speed and frame rate;Intraoperative registration navigation speed and frame rate;	—

Secondary

Measure	Time frame
Perioperative indicators (operative time, conversion to laparotomy rate, intraoperative blood loss, intraoperative blood transfusion);Evaluation of surgical performance;	—

Countries

China

Contacts

Public ContactJian Yang

Zhujiang Hospital, Southern Medical University

yangjian486@126.com+86 137 6069 4012

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026