Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery (OPTILIVER)

  • STATUS
    Recruiting
  • End date
    May 3, 2024
  • participants needed
    186
  • sponsor
    Institut Paoli-Calmettes
Updated on 9 April 2022

Summary

Major hepatectomies are high-risk surgeries offered more and more frequently for the curative treatment of primary or secondary liver cancer, and for complex cases, representing a real challenge for medical teams. The 1st peroperative phase of "hepatic resection" requires a minimum supply of filling fluids to limit perioperative bleeding (Low Central Venous Pressure). However this strategy exposes the risk of organ hypoperfusion due to low cardiac flow, secondary to hypovolaemia, which may lead to ischemic situations favoring the onset of postoperative complications. On the other hand, the hemodynamic management of the 2nd peroperative phase "post hepatic resection" is marked by the need to correct this hypoperfusion by optimizing cardiac output by suitable vascular filling.

The major challenge is thus to restore cardiac output by refilling without excess, by correcting the hypovolemia that arose during the "post resection of the hepatic parenchyma" phase.

Our hypothesis is that an individualized protocol for optimizing intraoperative cardiac flow by guided vascular filling during the "post hepatic resection" phase is accompanied by a reduction in postoperative complications in patients operated on for major hepatic surgery.

Details
Condition Primary or Metastatic Hepatic Adenocarcinoma
Treatment Control Arm, Optimization of cardiac flow by base water-electrolyte supply
Clinical Study IdentifierNCT04655885
SponsorInstitut Paoli-Calmettes
Last Modified on9 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Emergency surgery
Cirrhosis: depending on availability of CT and / or MRI imaging results, clinical examination, Biology (PT, Bilirubin) or histological results (preoperative biopsies in healthy liver)
Portal hypertension: depending on availability of imaging data, history of esophageal varices
Contraindication to fitting a tool for monitoring dynamic hemodynamic indices (case of esophageal varices for esophageal Doppler for example)
Benign tumors
Associated procedures programmed at the same operating time (excluding hepatic surgery): programmed associated digestive resection (colorectal or pancreatic)
Laparoscopy
Liver transplantation
Woman pregnant or likely to be (without effective contraception) or breastfeeding
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
Inability to undergo medical monitoring of the trial for geographical, social or psychological reasons
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