Trial Outcomes & Findings for Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis (NCT NCT02085915)
NCT ID: NCT02085915
Last Updated: 2026-05-05
Results Overview
Comparaison of Periscreen strip whith "Trace" threshold to the cytological analysis,
COMPLETED
NA
649 participants
Baseline
2026-05-05
Participant Flow
Overall, 649 patients from 21 French centers were included and 1422 Ascitic fluid of cirrothic patients hospitalized were assed.
803 Ascitic fluid samples from 315 outpatients and 599 samples from 334 inpatients.
Unit of analysis: Ascitic fluid samples
Participant milestones
| Measure |
Strip Peri Screen
Strip Peri Screen
|
|---|---|
|
Overall Study
STARTED
|
649 1422
|
|
Overall Study
COMPLETED
|
649 1402
|
|
Overall Study
NOT COMPLETED
|
0 20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Strip PeriScreen for the Fast Diagnosis of the Spontaneous Infection of the Liquid of Ascites During the Cirrhosis
Baseline characteristics by cohort
| Measure |
Strip Peri Screen
n=1402 Ascitic fluid samples
Strip Peri Screen
|
|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 10.4 • n=649 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=649 Participants
|
|
Sex: Female, Male
Male
|
499 Participants
n=649 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: 1402 paracenteses were performed on 649 patients
Comparaison of Periscreen strip whith "Trace" threshold to the cytological analysis,
Outcome measures
| Measure |
Suspiscion of Spontaneous Bacterial Peritonisis
n=1402 Ascitic fluid samples
Patient refered to hospital because suspiscion of spontaneous bacterial peritonisis underwent simultaneous Strip Peri Screen and PNN rate.
|
|---|---|
|
Sensitivity and Specificity
sensitivity
|
91.7 percentage
Interval 83.7 to 95.9
|
|
Sensitivity and Specificity
PPV
|
12.0 percentage
Interval 10.3 to 13.7
|
|
Sensitivity and Specificity
NPV
|
99.1 percentage
Interval 98.6 to 99.6
|
|
Sensitivity and Specificity
Specificity
|
57.1 percentage
Interval 54.4 to 59.8
|
Adverse Events
Strip Peri Screen
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Matthieu SCHNEE
Centre hospitalier départemental Vendée
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is not permitted to publish results without the sponsor's consent.
- Publication restrictions are in place
Restriction type: OTHER