Liver CirrhosesAMBICNCT03878563
Alterations in Intestinal Mucosal Barrier Visualized by Confocal Laser Endomicroscopy in Liver Cirrhosis: a Pilot Trial (AMBIC)
An observational study of Liver Cirrhoses, run by Dr.med. Monica Rusticeanu at 2 sites in Switzerland.
Trial summary
Clinical trial with medical devices. A diagnostic trial conducted to find a better (less invasive) procedure for predicting the onset of spontaneous bacterial peritonitis(SBP), which is a complication of liver cirrhosis with ascites.The current recommendation for primary prophylaxis of SBP include a low protein… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhoses
- What is being tested?
- Cellvisio 100 Series (fibered confocal microscopic system)
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 20 Nov 2017to 20 Jun 2019
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with liver cirrhosis and healthy controls, older than 18 years and younger than 80 years
Who may be able to join
- Adult individual (>18yo) with liver cirrhosis of any cause and healthy controls undergoing elective endoscopy
Who cannot join
- Patients younger than < 18, older than 80 years
- Pregnant or breastfeeding women
- Known allergy to fluorescein.
- Cardiac disease
- Asthma bronchiale
- Patients with inability or unwillingness to provide blood samples or samples of ascitic fluid.
Show all 9Show fewer
- patients unable to give informed consent
- non-resident patients
- contraindication for an endoscopic examination
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Universitätsspital Bern
Bern, 3010
Limmattal Spital
Schlieren, Canton of Zurich, 8952
About this study
Official title: Alterations in Intestinal Mucosal Barrier Visualized by Confocal Laser Endomicroscopy in Liver Cirrhosis: a Pilot Trial
Clinical trial with medical devices. A diagnostic trial conducted to find a better (less invasive) procedure for predicting the onset of spontaneous bacterial peritonitis(SBP), which is a complication of liver cirrhosis with ascites.The current recommendation for primary prophylaxis of SBP include a low protein content of the ascitic fluid or a gastrointestinal bleeding. This trial will use the CLE (confocal laser endomicroscopy) technic in order to quantify the intestinal permeability in patients with liver cirrhosis and correlate this to the onset of spontaneous bacterial peritonitis.We aim to evaluate a new diagnostic tool (the confocal laser endoscopy(CLE) technique -cellvizio- in the setting of endoscopy and defining parameters that are altered in cirrhotic patients of different severity and being at risk of developing a SBP (spontaneous bacterial peritonitis).The parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for time to occurrence of spontaneous bacterial peritonitis.
Defining a correlation between the quantified loss of intestinal integrity and i) total protein concentration in the ascitic fluid and ii) stadium of liver disease (Child class A, B or C)
- Conditions
- Liver Cirrhoses
- Being tested
- Cellvisio 100 Series (fibered confocal microscopic system)
- Keywords
- intestinal barrier dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellvisio 100 Series (fibered confocal microscopic system)Device
This system is intended to allow confocal laser imaging of the internal microstructure of tissues within or adjacent to anatomical tracts, i.e. Gastrointestinal accessed trough an endoscope.
An 488-nm wavelength laser system is used, images are steamed at a frame rate of 12 frames per second, obtaining real time videos of the mucosa. In this trial we will use the Confocal miniprobe ColoFlex UHD and GastroFlex UHD.
| Study group | Role | What they receive |
|---|---|---|
| ascites with/without SBP | Cirrhosis with ascites and existing SBP or prior SBP Receives: Device: Cellvisio 100 Series (fibered confocal microscopic system) | |
| ascites and decreased protein concentrati | Cirrhosis with ascites and decreased protein concentration <1,5 g/d Receives: Device: Cellvisio 100 Series (fibered confocal microscopic system) | |
| ascites and normal protein concentration | Liver cirrhosis witha scites and protein concentration >1,5 g/d Receives: Device: Cellvisio 100 Series (fibered confocal microscopic system) | |
| Liver cirrhosis without ascites | Patients with liver corrhosis without ascites Receives: Device: Cellvisio 100 Series (fibered confocal microscopic system) | |
| Healthy controls without liver cirrhosis or other pathology | Healthy pacients (without chronic disease) undergoing screening coloscopy or gastroscopy Receives: Device: Cellvisio 100 Series (fibered confocal microscopic system) |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of spontaneous bacterial peritonitis at 12 months
The parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for occurrence of spontaneous bacterial peritonitis for the next 12 months.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start20 Nov 2017
- Primary completion20 Jun 2019
- Study completion20 Jun 2019
Why it stopped: Sponsor-PI left Switzerland
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr.med. Monica Rusticeanu
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, University of Bern
- Responsible party
- Sponsor-investigator, Dr.med. Monica Rusticeanu, Spital Limmattal Schlieren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878563
- Sponsor's protocol ID
- 2017-00249
- Other IDs
- 2017
- Acronym
- AMBIC
- Status last verified
- Jul 2020
- First submitted
- 14 Mar 2019
- Last updated
- 13 Jul 2020
- 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 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Intestinal Mucosal Barrier Visualized by Confocal Laser Endomicroscopy in Liver Cirrhosis: a Pilot Trial
- ClinicalTrials.gov ID
- NCT03878563
- Acronym / sponsor ID
- AMBIC / 2017-00249
- Conditions
- Liver Cirrhoses
- Keywords
- intestinal barrier dysfunction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor-PI left Switzerland
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dr.med. Monica RusticeanuUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, University of Bern
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 18 Mar 2019 (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.
Clinical trial with medical devices. A diagnostic trial conducted to find a better (less invasive) procedure for predicting the onset of spontaneous bacterial peritonitis(SBP), which is a complication of liver cirrhosis with ascites.The current recommendation for primary prophylaxis of SBP include a low protein content of the ascitic fluid or a gastrointestinal bleeding. This trial will use the CLE (confocal laser endomicroscopy) technic in order to quantify the intestinal permeability in patients with liver cirrhosis and correlate this to the onset of spontaneous bacterial peritonitis.We aim to evaluate a new diagnostic tool (the confocal laser endoscopy(CLE) technique -cellvizio- in the setting of endoscopy and defining parameters that are altered in cirrhotic patients of different severity and being at risk of developing a SBP (spontaneous bacterial peritonitis).The parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for time to occurrence of spontaneous bacterial peritonitis.
Defining a correlation between the quantified loss of intestinal integrity and i) total protein concentration in the ascitic fluid and ii) stadium of liver disease (Child class A, B or C)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ascites with/without SBP | – | Device: Cellvisio 100 Series (fibered confocal microscopic system)Cirrhosis with ascites and existing SBP or prior SBP |
| ascites and decreased protein concentrati | – | Device: Cellvisio 100 Series (fibered confocal microscopic system)Cirrhosis with ascites and decreased protein concentration <1,5 g/d |
| ascites and normal protein concentration | – | Device: Cellvisio 100 Series (fibered confocal microscopic system)Liver cirrhosis witha scites and protein concentration >1,5 g/d |
| Liver cirrhosis without ascites | – | Device: Cellvisio 100 Series (fibered confocal microscopic system)Patients with liver corrhosis without ascites |
| Healthy controls without liver cirrhosis or other pathology | – | Device: Cellvisio 100 Series (fibered confocal microscopic system)Healthy pacients (without chronic disease) undergoing screening coloscopy or gastroscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis and healthy controls, older than 18 years and younger than 80 years
Key inclusion criteria (1 listed)
- Adult individual (>18yo) with liver cirrhosis of any cause and healthy controls undergoing elective endoscopy
Key exclusion criteria (9 listed)
- Patients younger than < 18, older than 80 years
- Pregnant or breastfeeding women
- Known allergy to fluorescein.
- Cardiac disease
- Asthma bronchiale
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 |
|---|---|---|
| Cellvisio 100 Series (fibered confocal microscopic system)This system is intended to allow confocal laser imaging of the internal microstructure of tissues within or adjacent to anatomical tracts, i.e. Gastrointestinal accessed trough an endoscope. An 488-nm wavelength laser system is used, images are steamed at a frame rate of 12 frames per second, obtaining real time videos of the mucosa. In this trial we will use the Confocal miniprobe ColoFlex UHD and GastroFlex UHD. | Device | Healthy controls without liver cirrhosis or other pathology, Liver cirrhosis without ascites, ascites and decreased protein concentrati, ascites and normal protein concentration, ascites with/without SBP |
Primary outcome
occurrence of spontaneous bacterial peritonitis at 12 months
Time frame: 24 months
The parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for occurrence of spontaneous bacterial peritonitis for the next 12 months.
Results and safety
The study was stopped early (reason given: Sponsor-PI left Switzerland). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
Related trials for Liver Cirrhoses
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Not yet recruiting
The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis
Cirrhoses, Liver
RecruitingPhase 4
Role of Allopurinol in Prevention of Complications Related to Decompensated Cirrhosis of Liver
Cirrhoses, Liver, Decompensated Cirrhosis of Liver
Not yet recruitingObservational study
Detecting Liver Fibrosis in Patients At-risk
Fatty Liver, NAFLD - Non-Alcoholic Fatty Liver Disease
Active, not recruitingObservational study
Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
Cirrhoses, Liver, Portal Hypertension Related to Cirrhosis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhoses, run by Dr.med. Monica Rusticeanu at 2 sites in Switzerland.
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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
The study was stopped early (reason given: Sponsor-PI left Switzerland). Results are not available in the source record.
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?
occurrence of spontaneous bacterial peritonitis at 12 months (time frame: 24 months). 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 13 Jul 2020.