Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis
Per-DRISLA
1 other identifier
interventional
649
2 countries
22
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 7, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
May 5, 2026
CompletedMay 5, 2026
April 1, 2026
1.4 years
March 7, 2014
October 1, 2025
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity
Comparaison of Periscreen strip whith "Trace" threshold to the cytological analysis,
Baseline
Study Arms (1)
strip Peri Screen
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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 ...).
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Hopital Jolimont
Haine-Saint-Paul, B-7100, Belgium
CH Amiens
Amiens, 80054, France
CHU Besançon
Besançon, 25000, France
CHRU de Brest
Brest, 29200, France
CH Caen
Caen, 14033, France
CH Cholet
Cholet, 49300, France
Hopîtal Beaujon
Clichy, 92118, France
Hopital Laennec
Creil, 60109, France
CH Dijon
Dijon, 21034, France
CH Gonesse
Gonesse, 95300, France
CHD Vendée
La Roche-sur-Yon, 85925, France
CH Lille
Lille, 59037, France
CHU Nice
Nice, 06200, France
CH Orléans
Orléans, 45067, France
CH Reims
Reims, 51092, France
CH Rennes
Rennes, 35000, France
CH Rouen
Rouen, 76031, France
CH St Antoine
Saint-Antoine, 75571, France
CH Yves Le Foll
Saint-Brieuc, 22027, France
CH Saint-Denis - Hôpital de la Fontaine
Saint-Denis, 93205, France
Hôpital Purpan
Toulouse, 31059, France
CH Vannes
Vannes, 56017, France
Related Publications (1)
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.
PMID: 27619833RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Matthieu SCHNEE
- Organization
- Centre hospitalier départemental Vendée
Study Officials
- STUDY DIRECTOR
Matthieu SCHNEE, Dr
CHD Vendée La Roche sur Yon
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2014
First Posted
March 13, 2014
Study Start
March 1, 2014
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
May 5, 2026
Results First Posted
May 5, 2026
Record last verified: 2026-04