Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy

NCT ID: NCT05887661

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2026-05-01

Brief Summary

The goal of this clinical trial is to learn about goal-directed LCVP based on hypovolemic phlebotomy (HP) in laparoscopic hepatectomy. The main questions it aims to answer are:

1. The safety and feasibility of HP

2. To evaluate whether HP can reduce perioperative blood transfusion ratio Participants undergoing liver resection with HP was performed by the anesthesiologist. Blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous. The aim was to maintain the CVP between 0 to 5 cmH2O. HP volume was 5-10 mL/kg of patient body weight, generally. Participants in control group undergoing liver resection without HP.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

hypovolemic phlebotomy (HP)

patients in this group undergoing laparoscopic hepatectomy was performed with goal-directed LCVP based on hypovolemic phlebotomy (HP)

Group Type: EXPERIMENTAL

hypovolemic phlebotomy

Intervention Type: PROCEDURE

hypovolemic phlebotomy was performed after induction of anesthesia and before the star of parenchymal division, with a goal-directed low central venous pressure drop to 5mmHg.

Control

patients in this group undergoing laparoscopic hepatectomy was performed with LCVP but no hypovolemic phlebotomy (HP)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

hypovolemic phlebotomy

hypovolemic phlebotomy was performed after induction of anesthesia and before the star of parenchymal division, with a goal-directed low central venous pressure drop to 5mmHg.

Intervention Type: PROCEDURE

Other Intervention Names

HP

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of Hepatocellular Carcinoma
• Preference for laparoscopic hepatectomy and patient agreement

Exclusion Criteria

• Age <18 years
• Pregnancy
• Refusal of blood product transfusion
• Active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, history of congestive heart failure)
• History of significant cerebrovascular disease
• Restrictive or obstructive pulmonary disease
• Uncontrolled hypertension
• Renal dysfunction (glomerular filtration rate <60 mL/min),
• Hemoglobin <100 g/L
• Abnormal coagulation values (international normalized ratio >1.5 not on warfarin and/or platelet count <100 ×109/L)
• Evidence of hepatic metabolic disorder (bilirubin >35 mmol/L)
• Presence of active infection
• Preoperative autologous blood donation
• Patients were not allowed to receive erythropoietin at any time during the index hospitalization.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shijiang Liu, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shijiang Liu, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shijiang Liu, MD

Role: CONTACT

liushijiang@jsph.org.cn

+862568303569

Yue Wang

Role: CONTACT

jsphkjwy@163.com

+862568136360

Facility Contacts

Shijiang Liu

Role: primary

liushijiang@jsph.org.cn

+86-25-68303569

Other Identifiers

2022-SR-102

Identifier Type: -

Identifier Source: org_study_id