Using hypovolemic phlebotomy to improve laparoscopic liver surgery outcomes
The Application of Goal-directed Low Central Venous Pressure Based on Hypovolemic Phlebotomy in Laparoscopic Hepatectomy
This study is testing whether a method that involves taking some blood out before liver surgery can help patients with liver cancer have safer surgeries and need fewer blood transfusions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05887661 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of goal-directed low central venous pressure (LCVP) based on hypovolemic phlebotomy (HP) during laparoscopic hepatectomy for patients with hepatocellular carcinoma. The study aims to assess the safety and feasibility of HP and its potential to reduce the need for blood transfusions during surgery. Participants will have blood withdrawn prior to liver parenchymal transection to maintain a specific central venous pressure. A control group will undergo liver resection without HP for comparison.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with hepatocellular carcinoma who prefer laparoscopic hepatectomy.
Not a fit: Patients under 18, pregnant, or with significant cardiac, pulmonary, or renal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer laparoscopic liver surgeries with reduced blood transfusion requirements.
How similar studies have performed: While the specific approach of using HP in laparoscopic hepatectomy may be novel, similar studies have shown promising results in managing blood loss during surgeries.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Shijiang Liu, MD — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: Shijiang Liu, MD
- Email: liushijiang@jsph.org.cn
- Phone: +862568303569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.