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A multicenter,prospective, randomized controlled study of laparoscopic versus open hepatectomy for BCLC stage 0-A HCC with diabetes

A multicenter,prospective, randomized controlled study of laparoscopic versus open hepatectomy for BCLC stage 0-A HCC with diabetes

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076091
Enrollment
Unknown
Registered
2023-09-25
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-03

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

Conditions

liver cancer

Interventions

Laparoscopic liver resection (experimental group):The patient adopts intravenous compound anesthesia, keeps the head high and foot low, according to the surgical site, choose the left or right elevate

Sponsors

Third Affiliated Hospital of Naval Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Be between 18 and 75 years old, regardless of gender; 2) Patients with liver cancer diagnosed by imaging, BCLC stage 0-A, surgeon evaluation for resection. 3) Preoperative liver function assessment Child-Pugh grade A or B, tumor diameter = 10cm, able to tolerate surgery; 4) Patients with type 2 diabetes mellitus (those with a history of diabetes in the past, or when the fasting blood glucose is greater than 7.0mmol/L after admission, the blood glucose > 11.1mmol/L 2 hours after meals, or glycated hemoglobin is greater than 6.5%); 5) Those with normal preoperative blood glucose control (fasting blood glucose = 6.1 mmol/L, 2-hour postprandial blood glucose = 7.8 mmol/L); 6) Patients with good cardiorespiratory function and able to tolerate surgery; 7) Those who can understand the study and have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) Topical treatment (including radiofrequency ablation, external radiation therapy) before enrollment; 2) Preoperative blood glucose is not controlled to normal; 3) The tumor has metastasized in distant places, such as: lung, brain, bone and other metastases; 4) Imaging showed portal vein, hepatic vein and vena cava cancer thrombus formation; 5) Severe varices of esophageal and gastric veins, gastrointestinal bleeding tendency, or previous history of gastrointestinal bleeding; 6) Heart, lung, kidney dysfunction. Oral warfarin and other anticoagulant drugs within 2 weeks; 7) The investigator believes that other reasons are not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Overall lifetime;Disease-free survival;

Secondary

MeasureTime frame
Amount of intraoperative bleeding;Intraoperative transfusion rate;Duration of surgery;Major postoperative morbidity;Number of days in hospital after surgery;

Countries

China

Contacts

Public ContactWeixing Guo

Third Affiliated Hospital of Naval Medical University

weixingg88@126.com+86 139 1858 9919

Outcome results

None listed

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