Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis (Per-DRISLA)

April 14, 2026 updated by: Centre Hospitalier Departemental Vendee

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

649

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Haine-Saint-Paul, Belgium, B-7100
        • Hopital Jolimont
  • France
      • Amiens, France, 80054
        • CH Amiens
      • Besançon, France, 25000
        • CHU Besancon
      • Brest, France, 29200
        • CHRU de Brest
      • Caen, France, 14033
        • CH Caen
      • Cholet, France, 49300
        • CH Cholet
      • Clichy, France, 92118
        • Hôpital Beaujon
      • Creil, France, 60109
        • Hôpital Laënnec
      • Dijon, France, 21034
        • CH Dijon
      • Gonesse, France, 95300
        • CH Gonesse
      • La Roche-sur-Yon, France, 85925
        • CHD Vendee
      • Lille, France, 59037
        • CH Lille
      • Nice, France, 06200
        • CHU Nice
      • Orléans, France, 45067
        • CH Orléans
      • Reims, France, 51092
        • CH Reims
      • Rennes, France, 35000
        • Ch Rennes
      • Rouen, France, 76031
        • CH Rouen
      • Saint-Antoine, France, 75571
        • CH St Antoine
      • Saint-Brieuc, France, 22027
        • CH Yves Le Foll
      • Saint-Denis, France, 93205
        • CH Saint-Denis - Hôpital de la Fontaine
      • Toulouse, France, 31059
        • Hopital Purpan
      • Vannes, France, 56017
        • CH Vannes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: strip Peri Screen
Other: strip Peri Screen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: Baseline
Comparaison of Periscreen strip whith "Trace" threshold to the cytological analysis,
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Study Director: Matthieu SCHNEE, Dr, CHD Vendée La Roche sur Yon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 11, 2014

First Posted (Estimated)

March 13, 2014

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD 065-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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