Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06594289

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

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-10-22

220

Participants Needed

1

Research Sites

80 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preoperative Child-Pugh classification of liver function Grade A or B
  • No contraindications for laparoscopic hepatectomy
  • Diagnosed with liver diseases such as primary liver cancer, hepatic hemangioma, intrahepatic bile duct calculus, or intrahepatic bile duct cell carcinoma
  • Voluntarily agree to participate and sign informed consent
  • Ban difficulty scoring system for laparoscopic hepatectomy score of 5 or greater; includes neoplasms near the hepatic portal or extensive hepatectomy (3 hepatic segments)
  • Aged between 18 and 70 years, inclusive
Not Eligible

You will not qualify if you...

  • Poor liver reserve function with ICG retention rate greater than 15%
  • Severe heart or lung diseases making general anesthesia unsafe
  • Previous liver surgery
  • Moderate or greater chest or abdominal fluid with symptoms
  • Hepatic encephalopathy
  • History of psychotropic drug abuse or mental disorders
  • Received solid organ or bone marrow transplantation within 2 years before surgery
  • Active autoimmune disease requiring systemic treatment
  • Immune deficiency disease or HIV infection
  • Considered unsuitable for inclusion by researchers
  • Disease progression, toxic side effects, or serious adverse events intolerable before surgery
  • Poor compliance, non-cooperation, concealment, or false reporting
  • Serious violation of research protocol as determined by principal investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Guangzhou, China/Guangdong, China

Actively Recruiting

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Research Team

Y

Yajin Chen

CONTACT

C

Changzhen Shang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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