Primary or Metastatic Hepatic AdenocarcinomaOPTILIVERNCT04655885
Cardiac Output Optimization on Postoperative Complications in Major Hepatic Surgery
A study testing Optimization of cardiac flow by base water-electrolyte supply in people with Primary or Metastatic Hepatic Adenocarcinoma, run by Institut Paoli-Calmettes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary or Metastatic Hepatic Adenocarcinoma
- What is being tested?
- Optimization of cardiac flow by base water-electrolyte supply
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2022to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, 13009
GENRE Dominique, MD, + 33 4 91 22 37 78, drci.up@ipc.unicancer.fr
GOUARNE Caroline, PhD, + 33 4 91 22 37 78, drci.up@ipc.unicancer.fr
About this study
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
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.
- Being tested
- Optimization of cardiac flow by base water-electrolyte supply, Control arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimization of cardiac flow by base water-electrolyte supplyBehavioural
optimization of cardiac flow by base water-electrolyte supply of 1 ml / kg / h by Ringer Lactate® and faced with any decrease of more than 10% of the VES compared to the reference VES, achievement of an optimization of the preload by administration of 250 ml of Ringer Lactate® with renewal until correction of the VES.
Control armBehavioural
increase basic hydro-electrolyte supply of 6 ml / kg / h by Ringer Lactate® and 1: 1 blood loss compensation by crystalloids of the same nature.
| Study group | Role | What they receive |
|---|---|---|
| Optimization of cardiac flow by base water-electrolyte supply | Experimental | Optimization of cardiac flow by base water-electrolyte supply of 1 ml / kg / h by Ringer Lactate® and faced with any decrease of more than 10% of the VES compared to the reference VES, achievement of an optimization of the preload by administration of 250 ml of Ringer Lactate® with renewal until correction of the VES. Receives: Behavioral: Optimization of cardiac flow by base water-electrolyte supply |
| Control arm | Other | Increase basic hydro-electrolyte supply of 6 ml / kg / h by Ringer Lactate® and 1: 1 blood loss compensation by crystalloids of the same nature. Receives: Behavioral: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the cardiac output optimization strategy on the occurrence of postoperative complications
Assessment of the impact of an individualized protocol for optimizing perioperative cardiac flow guided by monitoring of dynamic indices of preload dependence during the post-hepatic resection phase on the occurrence of postoperative complications in major hepatic surgery, for primary hepatic cancer or metastatic origin. We retain as the primary endpoint, the percentage of patients with at least one postoperative complication regardless of the grade in the Dindo-Clavien classification.
Measured: From Day 1 to Day 30 post-surgery
Secondary outcomes (5)
Evaluation of grade III-IV postoperative complication in the Dindo-Clavien classification
To determine whether the strategy for optimizing cardiac output guided by dynamic dependence preload indices is associated with a difference in the incidence of occurrence of at least one grade III-IV postoperative complication in the Dindo-Clavien classification
Measured: From Day 1 to Day 30 post-surgery
Evaluation of length of stay in the hospital
To determine whether the cardiac output optimization strategy guided by the dynamic dependence preload indices is associated with a difference in the length of stay in the Continuing Care Unit, intensive care unit or length of hospital stay or on re-hospitalization rates
Measured: From Day 1 to Day 30 post-surgery
Evaluation of mortality
To determine whether the cardiac output optimization strategy guided by the dynamic dependence preload indices is associated with a difference in mortality at D30 and D90
Measured: On Day 1, Day 30 and Day 90 post-surgery
Evaluation occurrence of organ failures
To determine whether the cardiac output optimization strategy guided by dynamic dependence preload indices has an impact on the occurrence of organ failures, which will be evaluated by the SOFA score per device from Day 1 to Day 7 postoperatively
Measured: From Day 1 to Day 7 post-surgery
Evaluation of hemodynamic parameters
To determine whether the cardiac output optimization strategy guided by dynamic dependence preload indices is associated with a difference on hemodynamic parameters
Measured: From Day 0 to Day 1 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start3 Feb 2022
- Primary completion15 Mar 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary or Metastatic Hepatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Manuel de Guibert, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655885
- Sponsor's protocol ID
- OPTILIVER TRIAL-IPC 2018-022
- Acronym
- OPTILIVER
- Status last verified
- Apr 2024
- First submitted
- 27 Nov 2020
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04655885
- Acronym / sponsor ID
- OPTILIVER / OPTILIVER TRIAL-IPC 2018-022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimization of cardiac flow by base water-electrolyte supply | Experimental | Behavioral: Optimization of cardiac flow by base water-electrolyte supplyOptimization of cardiac flow by base water-electrolyte supply of 1 ml / kg / h by Ringer Lactate® and faced with any decrease of more than 10% of the VES compared to the reference VES, achievement of an optimization of the preload by administration of 250 ml of Ringer Lactate® with renewal until correction of the VES. |
| Control arm | Other | Behavioral: Control armIncrease basic hydro-electrolyte supply of 6 ml / kg / h by Ringer Lactate® and 1: 1 blood loss compensation by crystalloids of the same nature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimization of cardiac flow by base water-electrolyte supplyoptimization of cardiac flow by base water-electrolyte supply of 1 ml / kg / h by Ringer Lactate® and faced with any decrease of more than 10% of the VES compared to the reference VES, achievement of an optimization of the preload by administration of 250 ml of Ringer Lactate® with renewal until correction of the VES. | Behavioural | Optimization of cardiac flow by base water-electrolyte supply |
| Control armincrease basic hydro-electrolyte supply of 6 ml / kg / h by Ringer Lactate® and 1: 1 blood loss compensation by crystalloids of the same nature. | Behavioural | Control arm |
Primary outcome
Evaluation of the cardiac output optimization strategy on the occurrence of postoperative complications
Time frame: From Day 1 to Day 30 post-surgery
Assessment of the impact of an individualized protocol for optimizing perioperative cardiac flow guided by monitoring of dynamic indices of preload dependence during the post-hepatic resection phase on the occurrence of postoperative complications in major hepatic surgery, for primary hepatic cancer or metastatic origin. We retain as the primary endpoint, the percentage of patients with at least one postoperative complication regardless of the grade in the Dindo-Clavien classification.
5 secondary outcomes
Evaluation of grade III-IV postoperative complication in the Dindo-Clavien classification
Time frame: From Day 1 to Day 30 post-surgery
Evaluation of length of stay in the hospital
Time frame: From Day 1 to Day 30 post-surgery
Evaluation of mortality
Time frame: On Day 1, Day 30 and Day 90 post-surgery
Evaluation occurrence of organ failures
Time frame: From Day 1 to Day 7 post-surgery
Evaluation of hemodynamic parameters
Time frame: From Day 0 to Day 1 post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
Related trials for Primary or Metastatic Hepatic Adenocarcinoma
Not yet recruitingObservational study
Preoperative 3D Magnetic Resonance Elastography for Predicting Surgical Risk in Patients Undergoing Hepatectomy
Hepatic Cancer, Hepatocellular Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Manuel de Guibert, MD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimization of cardiac flow by base water-electrolyte supply in people with Primary or Metastatic Hepatic Adenocarcinoma, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENRE, MD (+33 4 91 22 37 78, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the cardiac output optimization strategy on the occurrence of postoperative complications (time frame: From Day 1 to Day 30 post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.