Clinical trial NCT04655885: Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary or Metastatic Hepatic Adenocarcinoma
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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.

Primary outcomes:
measure: Evaluation of the cardiac output optimization strategy on the occurrence of postoperative complications
timeFrame: From Day 1 to Day 30 post-surgery
Secondary outcomes:
measure: Evaluation of grade III-IV postoperative complication in the Dindo-Clavien classification
timeFrame: From Day 1 to Day 30 post-surgery
measure: Evaluation of length of stay in the hospital
timeFrame: From Day 1 to Day 30 post-surgery
measure: Evaluation of mortality
timeFrame: On Day 1, Day 30 and Day 90 post-surgery
measure: Evaluation occurrence of organ failures
timeFrame: From Day 1 to Day 7 post-surgery
measure: Evaluation of hemodynamic parameters
timeFrame: From Day 0 to Day 1 post-surgery
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: Jean-Manuel de Guibert, MD
role: PRINCIPAL_INVESTIGATOR
References: