Back to resultsGoal-directed LCVP Based on HP in Laparoscopic Hepatectomy
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hypovolemic phlebotomy
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hypovolemic phlebotomy, low central venous pressure, goal-directed, laparoscopic hepatectomy
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.
Sites / Locations
- The First Affiliated Hospital of Nanjing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
hypovolemic phlebotomy (HP)
Control
Arm Description
patients in this group undergoing laparoscopic hepatectomy was performed with goal-directed LCVP based on hypovolemic phlebotomy (HP)
patients in this group undergoing laparoscopic hepatectomy was performed with LCVP but no hypovolemic phlebotomy (HP)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The volume of Phlebotomy
The volume of Intraoperative blood loss
The volume of Allogeneic transfusion (perioperative)
The volume of Allogeneic transfusion (postoperative)
The volume of Allogeneic transfusion (intraoperative)
The volume of Fresh frozen plasm (FFP) transfusion
The volume of Platelets transfusion
The volume of Albumin transfusion
Perioperative lowest concentration of Hb
Pre-transection central venous pressure (CVP), (basic CVP)
Lowest central venous pressure (CVP)
time of pringle maneuver
number of pringle maneuver
how many patients have the pringle maneuver
operating time
The proportion of laparoscopic hepatectomy converted to open liver resection
Length of stay
Number of Participants with postoperative complications (overall)
Full Information
NCT ID
NCT05887661
First Posted
March 1, 2023
Last Updated
June 1, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05887661
Brief Title
Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy
Official Title
The Application of Goal-directed Low Central Venous Pressure Based on Hypovolemic Phlebotomy in Laparoscopic Hepatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
The safety and feasibility of HP
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hypovolemic phlebotomy, low central venous pressure, goal-directed, laparoscopic hepatectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hypovolemic phlebotomy (HP)
Arm Type
Experimental
Arm Description
patients in this group undergoing laparoscopic hepatectomy was performed with goal-directed LCVP based on hypovolemic phlebotomy (HP)
Arm Title
Control
Arm Type
No Intervention
Arm Description
patients in this group undergoing laparoscopic hepatectomy was performed with LCVP but no hypovolemic phlebotomy (HP)
Intervention Type
Procedure
Intervention Name(s)
hypovolemic phlebotomy
Other Intervention Name(s)
HP
Intervention Description
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.
Primary Outcome Measure Information:
Title
The proportion of allogeneic red blood cell products transfusion
Description
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.
Time Frame
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 Outcome Measure Information:
Title
The volume of Phlebotomy
Time Frame
From the start of operation until the end of operation.
Title
The volume of Intraoperative blood loss
Time Frame
From the start of operation until the end of operation (during the operation).
Title
The volume of Allogeneic transfusion (perioperative)
Time Frame
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.
Title
The volume of Allogeneic transfusion (postoperative)
Time Frame
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.
Title
The volume of Allogeneic transfusion (intraoperative)
Time Frame
From the start of operation until the end of operation.
Title
The volume of Fresh frozen plasm (FFP) transfusion
Time Frame
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.
Title
The volume of Platelets transfusion
Time Frame
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.
Title
The volume of Albumin transfusion
Time Frame
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.
Title
Perioperative lowest concentration of Hb
Time Frame
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.
Title
Pre-transection central venous pressure (CVP), (basic CVP)
Time Frame
From the start of anesthesia induction until the star of operation.
Title
Lowest central venous pressure (CVP)
Time Frame
From the start of operation until the end of operation (during the operation).
Title
time of pringle maneuver
Time Frame
From the start of operation until the end of operation.
Title
number of pringle maneuver
Description
how many patients have the pringle maneuver
Time Frame
From the start of operation until the end of operation.
Title
operating time
Time Frame
From the start of operation until the end of operation.
Title
The proportion of laparoscopic hepatectomy converted to open liver resection
Time Frame
From the start of operation until the end of operation.
Title
Length of stay
Time Frame
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
Title
Number of Participants with postoperative complications (overall)
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shijiang Liu, MD
Phone
+862568303569
Email
liushijiang@jsph.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Wang
Phone
+862568136360
Email
jsphkjwy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shijiang Liu, MD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shijiang Liu
Phone
+86-25-68303569
Email
liushijiang@jsph.org.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy
We'll reach out to this number within 24 hrs