Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy

NCT05887661 | Recruiting

• 1 other identifier: 2022-SR-102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1.The safety and feasibility of HP
2. 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 Blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous.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

Keywords

hypovolemic phlebotomy; low central venous pressure; goal-directed; laparoscopic hepatectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• The volume of Phlebotomy

  From the start of operation until the end of operation.

• The volume of Intraoperative blood loss

  From the start of operation until the end of operation (during the operation).

• 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.

• 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.

• The volume of Allogeneic transfusion (intraoperative)

  From the start of operation until the end of operation.

Study Arms (2)

hypovolemic phlebotomy (HP)

EXPERIMENTAL

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

Procedure: hypovolemic phlebotomy

Control

NO INTERVENTION

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

Interventions

hypovolemic phlebotomy 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.

Also known as: HP

hypovolemic phlebotomy (HP)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Shijiang Liu, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shijiang Liu, MD

CONTACT

+862568303569; liushijiang@jsph.org.cn

Yue Wang

CONTACT

+862568136360; jsphkjwy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: June 5, 2023
• Study Start: May 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

CN (1)