Optimizing cardiac output during major liver surgery

Effect of an Individualized Protocol Based on Cardiac Output Optimization Guided by Dynamic Indices of Preload Responsiveness Monitoring on Postoperative Complications in Major Hepatic Surgery for Primary or Secondary Liver Cancer

This study tests a new way to manage fluid during major liver surgeries for cancer to see if it helps patients recover better and avoid complications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut Paoli-Calmettes (Academic / other)
• Locations: 1 site (Marseille)
• Trial ID: NCT04655885 on ClinicalTrials.gov

What this trial studies

This study focuses on patients undergoing major hepatic surgeries for liver cancer, aiming to optimize cardiac output during the perioperative period. It involves managing fluid supply to prevent organ hypoperfusion while minimizing the risk of postoperative complications. The intervention includes a controlled approach to fluid management to restore cardiac flow without causing excess fluid overload. The study hypothesizes that this optimization will lead to better outcomes for patients undergoing these high-risk procedures.

Who should consider this trial

Good fit: Ideal candidates are adults scheduled for major hepatic surgery for primary or metastatic liver cancer.

Not a fit: Patients with cirrhosis, portal hypertension, or those requiring emergency surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative complications in patients undergoing major liver surgeries.

How similar studies have performed: While the specific approach may be novel, similar studies focusing on hemodynamic optimization in surgical settings have shown promising results.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years old,
2. Signature of consent,
3. Any patient scheduled for major hepatic surgery (≥ 3 segments) scheduled by laparotomy, for primary hepatic cancer or secondary metastases,
4. Affiliation to the ''National security'' regimen or beneficiary of this regimen.

Exclusion Criteria:

1. Emergency surgery,
2. Cirrhosis: depending on availability of CT and / or MRI imaging results, clinical examination, Biology (PT, Bilirubin) or histological results (preoperative biopsies in healthy liver)
3. Portal hypertension: depending on availability of imaging data, history of esophageal varices
4. Contraindication to fitting a tool for monitoring dynamic hemodynamic indices (case of esophageal varices for esophageal Doppler for example),
5. Benign tumors,
6. Associated procedures programmed at the same operating time (excluding hepatic surgery): programmed associated digestive resection (colorectal or pancreatic),
7. Laparoscopy,
8. Liver transplantation,
9. Woman pregnant or likely to be (without effective contraception) or breastfeeding,
10. Person in an emergency situation, adult person subject to a legal protection measure (adult under guardianship, guardianship or legal protection), or unable to express consent,
11. Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons.

Where this trial is running

Marseille

• Institut Paoli Calmettes — Marseille, France (Recruiting)

Study contacts

• Principal investigator: Jean-Manuel de Guibert, MD — Institut Paoli-Calmettes
• Study coordinator: Dominique GENRE, MD

Conditions Primary or Metastatic Hepatic Adenocarcinoma