Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02085915

Acronym

Per-DRISLA

Enrollment

649

Registered

2014-03-13

Start date

2014-03-01

Completion date

2015-09-01

Last updated

2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Infection, Liquid of Ascites

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.

Interventions

OTHERstrip Peri Screen

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Belgium, France

Contacts

STUDY_DIRECTORMatthieu SCHNEE, Dr

CHD Vendée La Roche sur Yon

Participant flow

Recruitment details

Overall, 649 patients from 21 French centers were included and 1422 Ascitic fluid of cirrothic patients hospitalized were assed.

Pre-assignment details

803 Ascitic fluid samples from 315 outpatients and 599 samples from 334 inpatients.

Baseline characteristics

Characteristic	—
Age, Continuous	61.3 years STANDARD_DEVIATION 10.4
Sex: Female, Male Female	150 Participants
Sex: Female, Male Male	499 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 649
other Total, other adverse events	0 / 649
serious Total, serious adverse events	0 / 649

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026