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

ConditionLiver Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Poor liver reserve function, ICG retention rate > 15%;

severe heart and lung diseases, unable to tolerate general anesthesia surgery;

Previous history of liver surgery;

hepatic encephalopathy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • In laparoscopic hepatectomy, the subhepatic inferior vena cava was restricted and the patient was given non-restricted intraoperative fluid intake

    Procedure/Surgery

    The specific steps of IVC blocking were performed by the principal physician under laparoscopic operation: slightly incision of the posterior peritoneum on both sides of the inferior vena cava above the level of the renal vein. The "blood vessel blocking band" is passed behind the inferior vena cava on the left or right side of the inferior vena cava. According to the intraoperative situation, the blocking band (flow limiting blocking/incomplete blocking of subhepatic inferior vena cava) was tightened to control the bleeding from hepatic vein on the liver section. Patients in this group did not use vasoactive drugs/underuse means to control CVP, so they need to strictly communicate with the anesthesiologist, and take the fluid intake based on the physiological requirements and fluid loss of individual patients (cancel the restriction of fluid intake).

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Observation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative blood loss

The amount of intraoperative blood loss is an important index to evaluate surgical safety

Time frame
Up to approximately 20 months:September 2024 - May 2026
2

Intraoperative central venous pressure

Central venous pressure is an important factor in the evaluation of blood loss after subhepatic inferior vena cava occlusion

Time frame
Up to approximately 20 months:September 2024 - May 2026

Secondary outcomes

1

Level of aminotransferase

An important indicator of liver function

Time frame
Up to approximately 20 months:September 2024 - May 2026
2

level of Lactic acid

An important indicator of liver and kidney metabolic function

Time frame
Up to approximately 20 months:September 2024 - May 2026
3

Blood Sugar level

An important indicator of liver synthesis

Time frame
Up to approximately 20 months:September 2024 - May 2026
4

level of creatinine

An important indicator of kidney function

Time frame
Up to approximately 20 months:September 2024 - May 2026

Other outcomes

1

Postoperative complications, such as bile leakage, laparoscopic infection, deep vein thrombosis of the lower extremity, and unplanned re-entry surgery

Indicators to evaluate postoperative safety

Time frame
Up to approximately 20 months:September 2024 - May 2026

Sponsors and contacts

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