Hepatocellular CarcinomaNCT05887661
Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy
A study testing hypovolemic phlebotomy in people with Hepatocellular Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- hypovolemic phlebotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Hepatocellular Carcinoma
- Preference for laparoscopic hepatectomy and patient agreement
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Shijiang Liu, +86-25-68303569, liushijiang@jsph.org.cn
About this study
Official title: The Application of Goal-directed Low Central Venous Pressure Based on Hypovolemic Phlebotomy in Laparoscopic Hepatectomy
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- hypovolemic phlebotomy
- Keywords
- hypovolemic phlebotomy, low central venous pressure, goal-directed, laparoscopic hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypovolemic phlebotomyProcedure or surgery
Also called HP
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.
| Study group | Role | What they receive |
|---|---|---|
| hypovolemic phlebotomy (HP) | Experimental | patients in this group undergoing laparoscopic hepatectomy was performed with goal-directed LCVP based on hypovolemic phlebotomy (HP) Receives: Procedure: hypovolemic phlebotomy |
| Control | No intervention | patients in this group undergoing laparoscopic hepatectomy was performed with LCVP but no hypovolemic phlebotomy (HP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From the start of operation until the end of operation.
The volume of Intraoperative blood loss
Measured: From the start of operation until the end of operation (during the operation).
The volume of Allogeneic transfusion (perioperative)
Measured: 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)
Measured: 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)
Measured: From the start of operation until the end of operation.
The volume of Fresh frozen plasm (FFP) transfusion
Measured: 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 Platelets transfusion
Measured: 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 Albumin transfusion
Measured: 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.
Perioperative lowest concentration of Hb
Measured: 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.
Pre-transection central venous pressure (CVP), (basic CVP)
Measured: From the start of anesthesia induction until the star of operation.
Lowest central venous pressure (CVP)
Measured: From the start of operation until the end of operation (during the operation).
time of pringle maneuver
Measured: From the start of operation until the end of operation.
number of pringle maneuver
how many patients have the pringle maneuver
Measured: From the start of operation until the end of operation.
operating time
Measured: From the start of operation until the end of operation.
The proportion of laparoscopic hepatectomy converted to open liver resection
Measured: From the start of operation until the end of operation.
Length of stay
Measured: 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
Number of Participants with postoperative complications (overall)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 May 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shijiang Liu, MD, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Shijiang Liu, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887661
- Sponsor's protocol ID
- 2022-SR-102
- Status last verified
- Nov 2024
- First submitted
- 1 Mar 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Goal-directed Low Central Venous Pressure Based on Hypovolemic Phlebotomy in Laparoscopic Hepatectomy
- ClinicalTrials.gov ID
- NCT05887661
- Acronym / sponsor ID
- 2022-SR-102
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hypovolemic phlebotomy, low central venous pressure, goal-directed, laparoscopic hepatectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypovolemic phlebotomy (HP) | Experimental | Procedure: hypovolemic phlebotomypatients in this group undergoing laparoscopic hepatectomy was performed with goal-directed LCVP based on hypovolemic phlebotomy (HP) |
| Control | No intervention | –patients in this group undergoing laparoscopic hepatectomy was performed with LCVP but no hypovolemic phlebotomy (HP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Hepatocellular Carcinoma
- Preference for laparoscopic hepatectomy and patient agreement
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypovolemic phlebotomyAlso: HPhypovolemic 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. | Procedure or surgery | hypovolemic phlebotomy (HP) |
Primary outcome
The proportion of allogeneic red blood cell products 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.
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.
17 secondary outcomes
The volume of Phlebotomy
Time frame: From the start of operation until the end of operation.
The volume of Intraoperative blood loss
Time frame: From the start of operation until the end of operation (during the operation).
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.
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.
The volume of Allogeneic transfusion (intraoperative)
Time frame: From the start of operation until the end of operation.
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.
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.
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.
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.
Pre-transection central venous pressure (CVP), (basic CVP)
Time frame: From the start of anesthesia induction until the star of operation.
Lowest central venous pressure (CVP)
Time frame: From the start of operation until the end of operation (during the operation).
time of pringle maneuver
Time frame: From the start of operation until the end of operation.
number of pringle maneuver
Time frame: From the start of operation until the end of operation.
operating time
Time frame: From the start of operation until the end of operation.
The proportion of laparoscopic hepatectomy converted to open liver resection
Time frame: From the start of operation until the end of operation.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shijiang Liu, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypovolemic phlebotomy in people with Hepatocellular Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shijiang Liu, MD (+862568303569, liushijiang@jsph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of allogeneic red blood cell products 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.