RecruitingNot ApplicableNCT06594289

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


Sponsor

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

Enrollment

220 participants

Start Date

Sep 15, 2024

Study Type

INTERVENTIONAL

Conditions

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 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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a specific surgical technique during laparoscopic (keyhole) liver surgery that temporarily controls blood flow to reduce bleeding, while using a less restrictive fluid strategy during the operation. The goal is to improve surgical safety. **You may be eligible if...** - You are between 18 and 70 years old - You need laparoscopic liver surgery for conditions such as liver cancer, benign liver tumors, bile duct stones, or bile duct cancer - Your liver function is rated Grade A or B (Child-Pugh scale) - Your surgery is rated as moderately to highly complex **You may NOT be eligible if...** - Your liver reserve is poor (ICG retention rate above 15%) - You have serious heart or lung disease that prevents general anesthesia - You have had liver surgery before - You have significant fluid around your organs causing symptoms - You have liver-brain disease (hepatic encephalopathy), HIV, or active autoimmune disease requiring treatment - You have had an organ transplant within the past 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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).


Locations(1)

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

Guangzhou, China/Guangdong, China

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NCT06594289


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