Comparing two methods to reduce blood loss during liver surgery

Comparison the Effectiveness of Stroke Volume Variation Versus Central Venous Pressure Guidance for Reducing Perioperative Blood Loss During Open Liver Resection: A Prospective, Double-Blinded, Noninferiority, Randomized Controlled Study

This study is testing whether using a new way to monitor blood flow can help people having liver surgery lose less blood and need fewer blood transfusions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Chiang Mai University (Academic / other)
• Locations: 1 site (Chiang Mai, Chiangmai)
• Trial ID: NCT06905015 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of stroke volume variation (SVV) monitoring versus central venous pressure (CVP) guidance in minimizing perioperative blood loss during open liver resection surgeries. The study aims to determine which method better reduces intraoperative blood loss and the need for blood transfusions, which are critical factors affecting postoperative outcomes. Participants will be monitored using advanced hemodynamic techniques to optimize fluid management and minimize complications associated with excessive bleeding. The trial includes patients scheduled for elective liver resections due to various liver tumors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with specific liver tumors scheduled for elective open liver resection.

Not a fit: Patients with active cardiac conditions, significant cerebrovascular disease, or renal dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing liver resection.

How similar studies have performed: Previous studies have shown promising results with similar hemodynamic monitoring techniques, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* All genders, age 18 to 70 years old
* American Society of Anesthesiologists (ASA) physical status classification of I-III
* The patients who scheduled in elective open liver resection and diagnosed Hepatocellular Carcinoma, Cholangiocarcinoma, Liver metastasis, and Benign malignant tumor.

Exclusion Criteria:

* Pregnancy
* Active cardiac conditions (unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease, active coronary artery disease within 6 months prior surgery)
* History of significant cerebrovascular disease (Patients with clinically significant stroke/CVA within 6 months prior surgery, severe carotid stenosis)
* Renal dysfunction (GFR \< 60 ml/min/1.73 m²)
* Abnormal coagulation parameters (INR \>1.5 not on warfarin and/or platelet count \<100,000)
* Preoperative autologous blood donation
* Tumor size \> 10 cm.
* Previous liver resection

Withdrawal criteria:

* Unresectable tumor
* Persistent intraoperative hypotension that cannot be corrected with vasopressors.
* Cardiac arrest during operation
* Low central venous pressure (CVP \< 5 mmHg) or high stroke volume variation (SVV \>13%) cannot be achieved before and during liver parenchymal transection.

Where this trial is running

Chiang Mai, Chiangmai

• Department of Anesthesiology, Faculty of Medicine, Chiang Mai University — Chiang Mai, Chiangmai, Thailand (Recruiting)

Study contacts

• Principal investigator: Warangkana Lapisatepun, MD. PhD. — Chiang Mai University
• Study coordinator: Worakitti Lapisatepun, MD. PhD.

Conditions Liver Tumor; Surgery; Primary Liver Tumor, Metastatic Liver; Primary Liver Cancer; Liver Resection; Benign Liver Tumor; Stroke volume variation; central venous pressure