Evaluating a new method for laparoscopic liver surgery

Evaluation of the Safety and Effectiveness of Pringle Method Combined With IVC Flow Limiting and Blocking Method in Laparoscopic Hepatectomy Based on Non-restrictive Fluid Therapy Strategy

This study is testing a new way to perform laparoscopic liver surgery to see if it can reduce blood loss and improve recovery compared to the traditional method.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (other)
• Locations: 1 site (Guangzhou, China/Guangdong)
• Trial ID: NCT06594289 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of a novel approach to laparoscopic hepatectomy by combining the Pringle method with inferior vena cava (IVC) flow limiting and blocking techniques, while employing a non-restrictive fluid management strategy. A total of 220 patients undergoing elective laparoscopic partial hepatectomy will be randomly assigned to two groups: one using traditional fluid management and vasoactive drugs, and the other using the new method with open fluid intake and minimal vasoactive drug use. The study will compare various intraoperative and postoperative indicators, including blood loss, operation time, and liver function tests, to determine the benefits of the new approach.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-70 with Child-Pugh classification A or B liver function and specific liver diseases suitable for laparoscopic hepatectomy.

Not a fit: Patients with poor liver reserve function, severe heart and lung diseases, or a history of liver surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this method could lead to improved surgical outcomes and reduced dependence on vasoactive drugs during laparoscopic liver surgeries.

How similar studies have performed: While similar methods have been explored, this specific combination of techniques in laparoscopic hepatectomy represents a novel approach.

Eligibility criteria

Inclusion Criteria:

1. Preoperative Child-Pugh classification of liver function Grade A and grade B;
2. No contraindications for laparoscopic hepatectomy;
3. Liver diseases include: primary liver cancer, hepatic hemangioma, intrahepatic bile duct calculus, intrahepatic bile duct cell carcinoma, etc.
4. Patients voluntarily participate and sign informed consent;
5. According to the Ban difficulty scoring system of laparoscopic hepatectomy, patients with difficulty score of 5 or more were included; Neoplasms near the hepatic portal; Extensive hepatectomy (3 hepatic segments). Patients aged 18-70 years (including 18-70 years)

Exclusion Criteria:

1. Poor liver reserve function, ICG retention rate \> 15%;
2. severe heart and lung diseases, unable to tolerate general anesthesia surgery;
3. Previous history of liver surgery;
4. More than medium amount of chest and abdominal fluid with clinical symptoms:
5. hepatic encephalopathy;
6. having a history of psychotropic drug abuse, unable to quit or having a history of mental disorders;
7. Patients who have received solid organ transplantation or bone marrow transplantation, or within 2 years before surgery
8. An active autoimmune disease requiring systemic treatment has occurred;
9. There is an immune deficiency disease or HIV infection;
10. Those who were not considered suitable for inclusion by the researchers.
11. Progression of the disease or toxic side effects or serious adverse events that the subjects could not tolerate before surgery after treatment;
12. Poor patient compliance, non-cooperation, concealment, false reporting and other phenomena: others
13. Cases where the principal investigator determines that the research protocol is seriously violated.

Where this trial is running

Guangzhou, China/Guangdong

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Guangzhou, China/Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Yajin Chen

Conditions: Liver Tumor, Liver cancer, Laparoscopic