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

NCT06594289 | Recruiting

• 1 other identifier: SYSKY-2024-462-02
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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 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

Liver Tumor

Keywords

Liver cancer; Laparoscopic

Outcome Measures

Primary Outcomes (2)

• Intraoperative blood loss

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

  Up to approximately 20 months：September 2024 - May 2026

• Intraoperative central venous pressure

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

  Up to approximately 20 months：September 2024 - May 2026

Secondary Outcomes (4)

• Level of aminotransferase

  Up to approximately 20 months：September 2024 - May 2026

• level of Lactic acid

  Up to approximately 20 months：September 2024 - May 2026

• Blood Sugar level

  Up to approximately 20 months：September 2024 - May 2026

• level of creatinine

  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

  Up to approximately 20 months：September 2024 - May 2026

Study Arms (2)

Control group

NO INTERVENTION

Group A (Pringle method + restricted fluid management + use of vasoactive drugs by anesthesiologists) : The means of use and anesthetic drugs in this group were all conventional technical means without special intervention, so it was the control group.

Observation group

EXPERIMENTAL

Group B (Pringle method +IVC flow limiting and blocking method + open fluid intake during operation; Observation group: Patients in this group did not use anesthesia related drugs to control CVP, so they should strictly communicate with the anesthesiologist, and achieve homogeneity in the use of vasoactive drugs and narcotic drugs.

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

Interventions

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

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).

Observation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;
• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, China/Guangdong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yajin Chen

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

  STUDY DIRECTOR

Central Study Contacts

Yajin Chen

CONTACT

13719006202; cyj0509@126.com

Changzhen Shang

CONTACT

13711279678; shangchangzhen@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Complete random grouping method was used in this study. Patients meeting the inclusion criteria were assigned to group A and Group B in a 1:1 ratio with 110 cases in each group by random number table method. The results are hidden in an opaque sealed envelope, which is then stored by the clinical study designer (i.e., a random code sheet). The researcher opened the envelope on the morning of the operation to obtain the group of patients and informed the operating physician and anesthesiologist to intervene accordingly according to the study protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: March 31, 2026
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

CN (1)