Status:
RECRUITING
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
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Liver Tumor
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Overall design Research hypothesis: Based on the non-restrictive fluid management strategy (intraoperative fluid rehydration according to physiological requirements and expected loss, no or less use o...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06594289
Start Date
September 15 2024
End Date
March 31 2026
Last Update
October 22 2024
Active Locations (1)
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1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, China/Guangdong, China