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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| strip Peri Screen | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| strip Peri Screen | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity | Comparaison of Periscreen strip whith "Trace" threshold to the cytological analysis, | Baseline |
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Inclusion Criteria:
or
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthieu SCHNEE, Dr | CHD Vendée La Roche sur Yon | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Jolimont | Haine-Saint-Paul | B-7100 | Belgium | |||
| CH Amiens |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27619833 | Result | 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. |
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803 Ascitic fluid samples from 315 outpatients and 599 samples from 334 inpatients.
Overall, 649 patients from 21 French centers were included and 1422 Ascitic fluid of cirrothic patients hospitalized were assed.
| ID | Title | Description |
|---|---|---|
| FG000 | Strip Peri Screen | Strip Peri Screen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
1402 paracenteses were performed on 649 patients
| ID | Title | Description |
|---|---|---|
| BG000 | Strip Peri Screen | Strip Peri Screen |
| Units | Counts |
|---|---|
| Participants |
|
| Ascitic fluid samples |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| ||||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity and Specificity | Comparaison of Periscreen strip whith "Trace" threshold to the cytological analysis, | 1402 paracenteses were performed on 649 patients | Posted | Number | 95% Confidence Interval | percentage | Baseline | Ascitic fluid samples | Ascitic fluid samples |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strip Peri Screen | Strip Peri Screen | 0 | 649 | 0 | 649 | 0 | 649 |
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The PI is not permitted to publish results without the sponsor's consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Matthieu SCHNEE | Centre hospitalier départemental Vendée | 0251446572 | matthieu.schnee@ght85.fr |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
|---|---|
| Female |
|
| Male |
|
| Title | Measurements |
|---|---|
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| NPV |
|