Liver Function After Partial Liver ResectionPhase 4XeLivNCT03504033
Xenon-anesthesia on Patients Undergoing Major Liver-resection
A Phase 4 study testing Xenon and Desflurane in people with Liver Function After Partial Liver Resection, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The aim of this study is to compare the postoperative outcome of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Function After Partial Liver Resection
- What is being tested?
- Xenon and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 11 Apr 2018to 27 Sep 2019
- Phase
- Phase 4
- 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
- ≥ 3 segments liver resection
- ≥ 18 years
- Both gender
- American Society of Anesthesiologists (ASA) classification I-III
- Written informed consent prior to study participation
Who cannot join
- Subjects, fulfilling one or more of the following exclusion criteria will not be included in the study:
- Severe pulmonary or airway disease
- Severe liver disease, accompanied by a Child-Pugh class >A
- Allergy/hypersensitivity to study medications
- ASA ≥ IV
- Patients susceptible to malignant hyperthermia
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- Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods
- Patients with preeclampsia or eclampsia
- Patients legally unable to give written informed consent.
- Patients with risk of high oxygen demand
- Patient with seriously impaired cardiac function
- All contraindications for xenon anesthesia according to the summary of product characteristics LENOXe
- Patient participates in a parallel interventional clinical trial during this study or receives an investigational drug within 30 days prior to inclusion into this study
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen University, Department of Anesthesiology
Aachen, 52074
About this study
Official title: Xenon-anesthesia on Patients Undergoing Major Liver-resection: Randomized Controlled Trial
The aim of this study is to compare the postoperative outcome of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia.
Read the detailed description
The aim of this study is to compare the postoperative liver function and additional outcome parameters of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia. Xenon is known to maintain hemodynamic stability and consecutive tissue perfusion. Together with its potential for ischemic pre-conditioning, we hypothesize a protective effect of xenon on post-operative liver failure and ischemia/reperfusion injury.
- Being tested
- Xenon, Desflurane
- Keywords
- Xenon, Liver resection, post-operative liver failure, anesthetics, inhalation, Desflurane, Randomized controlled trail, RCT
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XenonDrug
Also called LenoXe
inhalation to maintain anesthesia
DesfluraneDrug
Also called Suprane
inhalation to maintain anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Xenon | Experimental | Xenon concentration of 50-60 % will be used for maintenance of general anesthesia and will be adjusted to maintain Bispectral index (BIS) value between 40 and 60. Receives: Drug: Xenon |
| Desflurane | Active comparator | Desflurane concentrations of 4-5%/0.8 minimum alveolar concentration (MAC) respectively will be used for maintenance of general anesthesia and will be adjusted to maintain BIS index value between 40 and 60. Receives: Drug: Desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-course of postoperative liver injury and function
The primary study outcome is the difference in postoperative liver injury and function between the two study arms, measured by the perioperative time-course of the liver transaminase alanine-aminotransferase (ALAT) preoperative and on postoperative days (POD) 1-3, 5 and 7.
Measured: Within the first 7 postoperative days
Secondary outcomes (37)
Intra- and postoperative blood loss
Difference of intra- and postoperative blood loss between the two study arms until discharge from ICU or POD 7 (whichever occurs first)
Measured: Surgery and ICU stay (maximum POD 7)
Quantity of intra- and postoperative infusions
Difference in quantity of infused crystalloids abd colloids between the two study arms until discharge from ICU or POD 7 (whichever occurs first)
Measured: Surgery and ICU stay (maximum POD 7)
Quantity of intra- and postoperative blood products
Difference in quantity of transfused packed red blood cells (RBCs), fresh frozen plasma (FFP) and platelet concentrates between the two study arms until discharge from ICU or POD 7 (whichever occurs first)
Measured: Surgery and ICU stay (maximum POD 7)
Quantity of intra- and postoperative coagulation products
Difference in quantity of administered tranexamic acid, fibrinogen and prothrombin complex concentrates between the two study arms until discharge from ICU or POD 7 (whichever occurs first)
Measured: Surgery and ICU stay (maximum POD 7)
Necessity and duration of surgical pringle maneuver
Difference in necessity and duration of intraoperative pringle maneuver performed by the surgeon between study groups
Measured: Surgery
Necessity and duration of surgical total vascular occlusion
Difference in necessity and duration of intraoperative total vascular occlusion performed by the surgeon between study groups
Measured: Surgery
Surgery time
Difference in surgery time between study groups
Measured: Surgery
Fibrosis in the resected liver tissue
Difference in fibrosis in the resected liver tissue between the two study arms
Measured: Surgery
Number of hepatocytes in synthesis phase in the resected liver tissue
Difference in number of hepatocytes in synthesis phase in the resected liver tissue between the two study arms
Measured: Surgery
Number of macrophages in the resected liver tissue
Difference in number of macrophages in the resected liver tissue between the two study arms
Measured: Surgery
Expression of Interleukin 6 (IL-6) in the resected liver tissue
Difference in expression of Interleukin 6 (IL-6) in the resected liver tissue between the two study arms
Measured: Surgery
Expression of tumor necrosis factor (TNF) in the resected liver tissue
Difference in expression of tumor necrosis factor (TNF) in the resected liver tissue between the two study arms
Measured: Surgery
Expression of hepatocyte growth factor (HGF) in the resected liver tissue
Difference in expression of hepatocyte growth factor (HGF) in the resected liver tissue between the two study arms
Measured: Surgery
Expression of epidermal growth factor (EGF) in the resected liver tissue
Difference in expression of epidermal growth factor (EGF) in the resected liver tissue between the two study arms
Measured: Surgery
Expression of fibroblast growth factor (FGF) in the resected liver tissue
Difference in expression of fibroblast growth factor (FGF) in the resected liver tissue between the two study arms
Measured: Surgery
Expression of insulin-like growth factors I/II (IGF-I/II) in the resected liver tissue
Difference in expression of insulin-like growth factors I/II (IGF-I/II) in the resected liver tissue between the two study arms
Measured: Surgery
Weight of the resected liver tissue
Difference in weight of the resected liver tissue normalized to body weight (%BW) between the two study arms
Measured: Surgery
Computer tomography-assisted planimetry of the resected liver tissue
Difference in area of the resected liver tissue, assessed with computer tomography assisted planimetry, between the two study arms
Measured: Surgery
Time-course of hemoglobin (Hb)
Difference in laboratory data, measured by the time-course of hemoglobin (Hb), between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)
Measured: Within the first 7 postoperative days
Time-course of platelet count
Difference in laboratory data, measured by the time-course of platelet count, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)
Measured: Within the first 7 postoperative days
Time-course of prothrombin time (PT)
Difference in laboratory data, measured by the time-course of prothrombin time (PT), between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)
Measured: Within the first 7 postoperative days
Time-course of partial thromboplastin time (PTT)
Difference in laboratory data, measured by the time-course of partial thromboplastin time (PTT), between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)
Measured: Within the first 7 postoperative days
Time-course of bilirubin
Difference in laboratory data, measured by the time-course of bilirubin, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)
Measured: Within the first 7 postoperative days
Time-course of aspartate aminotransferase (ASAT)
Difference in laboratory data, measured by the time-course of aspartate aminotransferase (ASAT), between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)
Measured: Within the first 7 postoperative days
Time-course of creatinine
Difference in laboratory data, measured by the time-course of creatinine, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)
Measured: Within the first 7 postoperative days
Time-course of lactate
Difference in laboratory data, measured by the time-course of lactate, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)
Measured: Within the first 7 postoperative days
Time-course of albumin
Difference in laboratory data, measured by the time-course of albumin, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)
Measured: Within the first 7 postoperative days
Time-course of international normalized ratio (INR)
Difference in laboratory data, measured by the time-course of international normalized ratio (INR) levels, between the two study arms postoperatively until discharge from ICU or POD 7 (whichever occurs first)
Measured: Within the first 7 postoperative days
Postoperative peak of blood lactate
Difference in postoperative peak of blood lactate between the two study groups until discharge from ICU or POD 7 (whichever occurs first)
Measured: During ICU stay, maximum POD 7
Length of ICU stay
Difference in ICU length of stay between the two study arms
Measured: Until postoperative day 30
Length of hospital stay
Difference in hospital length of stay between the two study arms
Measured: Until postoperative day 30
Postoperative mortality
Difference in mortality between the two study arms until postoperative day 30
Measured: Until postoperative day 30
Adverse events
Difference in quality and quantity of adverse events between the two study arms
Measured: Until postoperative day 30
Difference in mortality, assessed by 30 days follow up via phone
Difference in mortality between the two study arms
Measured: Postoperative day 30
Difference in coagulation disorder, assessed by 30 days follow up via phone
Difference in coagulation disorder between the two study arms
Measured: Postoperative day 30
Difference in re-admission to hospital, assessed by 30 days follow up via phone
Difference in re-admission to hospital between the two study arms
Measured: Postoperative day 30
Difference in other adverse events, assessed by 30 days follow up via phone
Difference in other adverse events between the two study arms
Measured: Postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start11 Apr 2018 (estimated)
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Why it stopped: A device would have had to be maintained. The maintenance company is insolvent; both another maintenance company and another serviced device were not available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Function After Partial Liver ResectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, controlled, double-blinded, randomized, two-arm parallel, interventional clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana Kowark, MD, Principal investigator, RWTH Aachen University HospitalMark Coburn, MD, PhD, Study director, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504033
- Sponsor's protocol ID
- 15-163
- Acronym
- XeLiv
- Status last verified
- Oct 2019
- First submitted
- 14 Mar 2018
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenon-anesthesia on Patients Undergoing Major Liver-resection: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03504033
- Acronym / sponsor ID
- XeLiv / 15-163
- Keywords
- Xenon, Liver resection, post-operative liver failure, anesthetics, inhalation, Desflurane, Randomized controlled trail, RCT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A device would have had to be maintained. The maintenance company is insolvent; both another maintenance company and another serviced device were not available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 11 Apr 2018 (estimated)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 20 Apr 2018 (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.
The aim of this study is to compare the postoperative outcome of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia.
Detailed description
The aim of this study is to compare the postoperative liver function and additional outcome parameters of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia. Xenon is known to maintain hemodynamic stability and consecutive tissue perfusion. Together with its potential for ischemic pre-conditioning, we hypothesize a protective effect of xenon on post-operative liver failure and ischemia/reperfusion injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, controlled, double-blinded, randomized, two-arm parallel, interventional clinical trial
| Arm | Type | Receives |
|---|---|---|
| Xenon | Experimental | Drug: XenonXenon concentration of 50-60 % will be used for maintenance of general anesthesia and will be adjusted to maintain Bispectral index (BIS) value between 40 and 60. |
| Desflurane | Active comparator | Drug: DesfluraneDesflurane concentrations of 4-5%/0.8 minimum alveolar concentration (MAC) respectively will be used for maintenance of general anesthesia and will be adjusted to maintain BIS index value between 40 and 60. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 3 segments liver resection
- ≥ 18 years
- Both gender
- American Society of Anesthesiologists (ASA) classification I-III
- Written informed consent prior to study participation
Key exclusion criteria (13 listed)
- Subjects, fulfilling one or more of the following exclusion criteria will not be included in the study:
- Severe pulmonary or airway disease
- Severe liver disease, accompanied by a Child-Pugh class >A
- Allergy/hypersensitivity to study medications
- ASA ≥ IV
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 |
|---|---|---|
| XenonAlso: LenoXeinhalation to maintain anesthesia | Drug | Xenon |
| DesfluraneAlso: Supraneinhalation to maintain anesthesia | Drug | Desflurane |
Primary outcome
Time-course of postoperative liver injury and function
Time frame: Within the first 7 postoperative days
The primary study outcome is the difference in postoperative liver injury and function between the two study arms, measured by the perioperative time-course of the liver transaminase alanine-aminotransferase (ALAT) preoperative and on postoperative days (POD) 1-3, 5 and 7.
37 secondary outcomes
Intra- and postoperative blood loss
Time frame: Surgery and ICU stay (maximum POD 7)
Quantity of intra- and postoperative infusions
Time frame: Surgery and ICU stay (maximum POD 7)
Quantity of intra- and postoperative blood products
Time frame: Surgery and ICU stay (maximum POD 7)
Quantity of intra- and postoperative coagulation products
Time frame: Surgery and ICU stay (maximum POD 7)
Necessity and duration of surgical pringle maneuver
Time frame: Surgery
Necessity and duration of surgical total vascular occlusion
Time frame: Surgery
Surgery time
Time frame: Surgery
Fibrosis in the resected liver tissue
Time frame: Surgery
Number of hepatocytes in synthesis phase in the resected liver tissue
Time frame: Surgery
Number of macrophages in the resected liver tissue
Time frame: Surgery
Expression of Interleukin 6 (IL-6) in the resected liver tissue
Time frame: Surgery
Expression of tumor necrosis factor (TNF) in the resected liver tissue
Time frame: Surgery
Expression of hepatocyte growth factor (HGF) in the resected liver tissue
Time frame: Surgery
Expression of epidermal growth factor (EGF) in the resected liver tissue
Time frame: Surgery
Expression of fibroblast growth factor (FGF) in the resected liver tissue
Time frame: Surgery
Expression of insulin-like growth factors I/II (IGF-I/II) in the resected liver tissue
Time frame: Surgery
Weight of the resected liver tissue
Time frame: Surgery
Computer tomography-assisted planimetry of the resected liver tissue
Time frame: Surgery
Time-course of hemoglobin (Hb)
Time frame: Within the first 7 postoperative days
Time-course of platelet count
Time frame: Within the first 7 postoperative days
Time-course of prothrombin time (PT)
Time frame: Within the first 7 postoperative days
Time-course of partial thromboplastin time (PTT)
Time frame: Within the first 7 postoperative days
Time-course of bilirubin
Time frame: Within the first 7 postoperative days
Time-course of aspartate aminotransferase (ASAT)
Time frame: Within the first 7 postoperative days
Time-course of creatinine
Time frame: Within the first 7 postoperative days
Time-course of lactate
Time frame: Within the first 7 postoperative days
Time-course of albumin
Time frame: Within the first 7 postoperative days
Time-course of international normalized ratio (INR)
Time frame: Within the first 7 postoperative days
Postoperative peak of blood lactate
Time frame: During ICU stay, maximum POD 7
Length of ICU stay
Time frame: Until postoperative day 30
Length of hospital stay
Time frame: Until postoperative day 30
Postoperative mortality
Time frame: Until postoperative day 30
Adverse events
Time frame: Until postoperative day 30
Difference in mortality, assessed by 30 days follow up via phone
Time frame: Postoperative day 30
Difference in coagulation disorder, assessed by 30 days follow up via phone
Time frame: Postoperative day 30
Difference in re-admission to hospital, assessed by 30 days follow up via phone
Time frame: Postoperative day 30
Difference in other adverse events, assessed by 30 days follow up via phone
Time frame: Postoperative day 30
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: No
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.
Ana Kowark, MD principal investigator
RWTH Aachen University Hospital
Mark Coburn, MD, PhD study director
RWTH Aachen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xenon and Desflurane in people with Liver Function After Partial Liver Resection, run by RWTH Aachen University at 1 site in Germany.
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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 29 Oct 2019. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-course of postoperative liver injury and function (time frame: Within the first 7 postoperative days). 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 29 Oct 2019.