CirrhosisPer-DRISLANCT02085915
Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis
A study testing strip Peri Screen in people with Cirrhosis and Liquid of Ascites, run by Centre Hospitalier Departemental Vendee at 22 sites in 2 countries.
Trial summary
The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an essential stake to improve the forecast. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liquid of Ascites, Infection
- What is being tested?
- strip Peri Screen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 649 participants
- Where
- 22 sitesin 2 countries
- Study dates
- Mar 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female over 18 years
- Presence of ascites due to cirrhosis
- Hospitalization for a complication of cirrhosis (ascites first decompensation, gastrointestinal bleeding, encephalopathy, etc ...).
- or
- Hospitalization to perform a paracentesis evacuated outpatient
- Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis and with clinical and/or biological signs that suggest spontaneous infection of ascite.
Who cannot join
- Patients with ascites urgently admitted to hospital for suspected infection receiving antibiotics for more than 12 hours.
- chylous ascites,
- Hemorrhagic Ascites
- Biliary Ascites (straw)
- Ascites heterogeneous appearance
- Ascites not related to portal hypertension (peritoneal carcinomatosis, pancreatic ascites, tuberculosis, etc ...)
- Patient receiving imipenem IV.
- Patients on long-term antibiotic primary or secondary prophylaxis the spontaneous bacterial peritonitis without clinical and/or biological signs that suggest spontaneous infection of ascite.
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
France21 sites
CH Amiens
Amiens, 80054
CHU Besançon
Besançon, 25000
CHRU de Brest
Brest, 29200
CH Caen
Caen, 14033
CH Cholet
Cholet, 49300
Hopîtal Beaujon
Clichy, 92118
Hopital Laennec
Creil, 60109
CH Dijon
Dijon, 21034
CH Gonesse
Gonesse, 95300
CHD Vendée
La Roche-sur-Yon, 85925
CH Lille
Lille, 59037
CHU Nice
Nice, 06200
CH Orléans
Orléans, 45067
CH Reims
Reims, 51092
CH Rennes
Rennes, 35000
CH Rouen
Rouen, 76031
CH St Antoine
Saint-Antoine, 75571
CH Yves Le Foll
Saint-Brieuc, 22027
CH Saint-Denis - Hôpital de la Fontaine
Saint-Denis, 93205
Hôpital Purpan
Toulouse, 31059
CH Vannes
Vannes, 56017
About this study
The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an essential stake to improve the forecast.
Investigators would so like to estimate the interest of the strip PeriScreen for the fast diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients, what would allow to make out a will at least on ascites 2000 on about twenty centers for duration estimated of 12 months.
- Conditions
- Cirrhosis, Liquid of Ascites, Infection
- Being tested
- strip Peri Screen
- Medical subject headings
- Fibrosis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strip Peri ScreenOther
| Study group | Role | What they receive |
|---|---|---|
| strip Peri Screen | Other | Not described Receives: Other: strip Peri Screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Comparaison of Periscreen strip whith "Trace" threshold to the cytological analysis,
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu SCHNEE, Dr, Study director, CHD Vendée La Roche sur Yon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085915
- Sponsor's protocol ID
- CHD 065-13
- Acronym
- Per-DRISLA
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2014
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Thevenot T, Briot C, Mace V, Lison H, Elkrief L, Heurgue-Berlot A, Bureau C, Jezequel C, Riachi G, Louvet A, Pauwels A, Ollivier-Hourmand I, Anty R, Carbonell N, Labadie H, Aziz K, Grasset D, Nguyen-Khac E, Kaassis M, Hermann S, Tanne F, Mouillot T, Roux O, Le Thuaut A, Cervoni JP, Cadranel JF, Schnee M; CFEHTP, ANGH and the PerDRISLA study group. The Periscreen Strip Is Highly Efficient for the Exclusion of Spontaneous Bacterial Peritonitis in Cirrhotic Outpatients. Am J Gastroenterol. 2016 Oct;111(10):1402-1409. doi: 10.1038/ajg.2016.344. Epub 2016 Sep 13.
PubMed 27619833
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis
- ClinicalTrials.gov ID
- NCT02085915
- Acronym / sponsor ID
- Per-DRISLA / CHD 065-13
- Conditions
- Cirrhosis, Liquid of Ascites, Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The forecast of the spontaneous infection of the liquid of ascites (ISLA) at the cirrhotic patient is still burdened by a heavy mortality. The fast diagnosis of the ISLA is thus an essential stake to improve the forecast.
Investigators would so like to estimate the interest of the strip PeriScreen for the fast diagnosis of the ISLA at cirrhotic patients . Investigators plan to include 670 patients, what would allow to make out a will at least on ascites 2000 on about twenty centers for duration estimated of 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| strip Peri Screen | Other | Other: strip Peri Screen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female over 18 years
- Presence of ascites due to cirrhosis
- Hospitalization for a complication of cirrhosis (ascites first decompensation, gastrointestinal bleeding, encephalopathy, etc ...).
- or
- Hospitalization to perform a paracentesis evacuated outpatient
Key exclusion criteria (8 listed)
- Patients with ascites urgently admitted to hospital for suspected infection receiving antibiotics for more than 12 hours.
- chylous ascites,
- Hemorrhagic Ascites
- Biliary Ascites (straw)
- Ascites heterogeneous appearance
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 |
|---|---|---|
| strip Peri Screen | Other | strip Peri Screen |
Primary outcome
Sensitivity and Specificity
Time frame: Baseline
Comparaison of Periscreen strip whith "Trace" threshold to the cytological analysis,
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27619833Thevenot T, Briot C, Mace V, Lison H, Elkrief L, Heurgue-Berlot A, Bureau C, Jezequel C, Riachi G, Louvet A, Pauwels A, Ollivier-Hourmand I, Anty R, Carbonell N, Labadie H, Aziz K, Grasset D, Nguyen-Khac E, Kaassis M, Hermann S, Tanne F, Mouillot T, Roux O, Le Thuaut A, Cervoni JP, Cadranel JF, Schnee M; CFEHTP, ANGH and the PerDRISLA study group. The Periscreen Strip Is Highly Efficient for the Exclusion of Spontaneous Bacterial Peritonitis in Cirrhotic Outpatients. Am J Gastroenterol. 2016 Oct;111(10):1402-1409. doi: 10.1038/ajg.2016.344. Epub 2016 Sep 13.
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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.
Matthieu SCHNEE, Dr study director
CHD Vendée La Roche sur Yon
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strip Peri Screen in people with Cirrhosis and Liquid of Ascites, run by Centre Hospitalier Departemental Vendee at 22 sites in 2 countries.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in France, Belgium. 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?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity and Specificity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02085915, which also lists 1 linked publication.
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 5 May 2026.