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

Recruiting now · Not applicable

Conditions studied: Liver Tumor

In brief

The relevant data of 220 patients undergoing laparoscopic hepatectomy in our hospital were collected. Based on randomization, blindness and inclusion and exclusion criteria, the patients were divided into group A (which included Pringle method + restricted fluid management + vasoactive drug use by anesthesiologists) and group B (which included: Pringle method +IVC flow limiting and blocking method, intraoperative fluid rehydration according to physiological requirements and expected loss, no or less vasoactive drugs used during the operation), and intraoperative and postoperative relevant indicators were compared between the two groups, such as; CVP value, fluctuation range, length of operation, time of liver amputation, total blood loss, amount of liver amputation, amount of blood transfusion, and amount of fluid perfusion. Internal environmental indicators: albumin, alanine aminotransferase, aspartate aminotransferase, γ-gt, total bilirubin, renal function, lactic acid, blood gas analysis (three times during the operation). Postoperative indexes: average length of stay and unplanned reoperation rate. While taking into account the safety, effectiveness and interpretability of statistical results, a new laparoscopic hepatectomy technique based on the optimized CLCVP process was constructed to control intraoperative bleeding and GDFT standardized and streamlined intervention strategy. This is not only an important innovation of the CLVCP concept, but also an important link to accelerate the implementation of laparoscopic liver resection technology in grassroots hospitals, and will significantly improve the quality of medical services, which can bring more accurate and efficient treatment programs to patients.

Key facts

Study ID

NCT06594289

Run by

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

People needed

220

Starts

2024-09-15

Expected to finish

2026-03-31

Last updated by the study team

2024-10-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Preoperative Child-Pugh classification of liver function Grade A and grade B;
• No contraindications for laparoscopic hepatectomy;
• Liver diseases include: primary liver cancer, hepatic hemangioma, intrahepatic bile duct calculus, intrahepatic bile duct cell carcinoma, etc.
• Patients voluntarily participate and sign informed consent;
• 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)

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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