Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy

Hepatocellular Carcinoma Clinical Trial

Official title:

The Application of Goal-directed Low Central Venous Pressure Based on Hypovolemic Phlebotomy in Laparoscopic Hepatectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05887661
• Other study ID #: 2022-SR-102
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Shijiang Liu, MD
• Phone: +862568303569
• Email: liushijiang[@]jsph.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of allogeneic red blood cell products transfusion	The primary end point of the study was the proportion of patients who required transfusion of allogeneic red blood cell products during laparoscopic hepatectomy or at any time during the hospitalization during the index admission.	From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
Secondary	The volume of Phlebotomy		From the start of operation until the end of operation.
Secondary	The volume of Intraoperative blood loss		From the start of operation until the end of operation (during the operation).
Secondary	The volume of Allogeneic transfusion (perioperative)		From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
Secondary	The volume of Allogeneic transfusion (postoperative)		From the end of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
Secondary	The volume of Allogeneic transfusion (intraoperative)		From the start of operation until the end of operation.
Secondary	The volume of Fresh frozen plasm (FFP) transfusion		From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
Secondary	The volume of Platelets transfusion		From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
Secondary	The volume of Albumin transfusion		From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 12 months.
Secondary	Perioperative lowest concentration of Hb		From the start of operation until the date of discharge from hospital or date of death from any cause, whichever came first. assessed up to 12 months.
Secondary	Pre-transection central venous pressure (CVP), (basic CVP)		From the start of anesthesia induction until the star of operation.
Secondary	Lowest central venous pressure (CVP)		From the start of operation until the end of operation (during the operation).
Secondary	time of pringle maneuver		From the start of operation until the end of operation.
Secondary	number of pringle maneuver	how many patients have the pringle maneuver	From the start of operation until the end of operation.
Secondary	operating time		From the start of operation until the end of operation.
Secondary	The proportion of laparoscopic hepatectomy converted to open liver resection		From the start of operation until the end of operation.
Secondary	Length of stay		From date of hospitalization until the date of discharge from hospital or date of death from any cause, whichever came first. assessed up to 12 months
Secondary	Number of Participants with postoperative complications (overall)		From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 months.