Rapid on-site evaluation (ROSE) vs. randomly collected samples from mediastinal and abdominal lymph nodes obtained by endoscopic ultrasound-guided fine-needle-aspiration

Rapid on-site evaluation (ROSE) vs. randomly collected samples from mediastinal and abdominal lymph nodes obtained by endoscopic ultrasound-guided fine-needle-aspiration - ROSE-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45053

Enrollment

244

Registered

2013-12-24

Start date

2014-02-27

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Enlarged lymph nodes lymphadenopathy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: >=18 years old Scheduled to undergo endoscopic ultrasound (EUS) with fine-needle aspiration (FNA) of a lymph node in either the mediastinum or the abdomen Written informed consent

Exclusion criteria

Exclusion criteria: Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study Coagulopathy (INR>1.5, platelets

Design outcomes

Primary

Measure	Time frame
The primary parameter is the percentage of cases in which the cytopathologist can make a diagnosis on the contents of the lymph node, based on the EUS-FNA samples of the lymph node. (=diagnostic yield)	—

Secondary

Measure	Time frame
-Diagnostic accuracy -Sensitivity, specificity, negative predictive value and positive predictive value of a certain number of needle passes in both groups. -Judgment of the cytotechnician on-site and the cytopathologist of each sample -Number of needle passes required per case according to the cytotechnician on-site and according to the cytopathologist in both groups. -Time required in both groups. -Cost-effectivity of both approaches. -Number and nature of complications in both groups.	—

Measure

Time frame

-Diagnostic accuracy -Sensitivity, specificity, negative predictive value and positive predictive value of a certain number of needle passes in both groups. -Judgment of the cytotechnician on-site and the cytopathologist of each sample -Number of needle passes required per case according to the cytotechnician on-site and according to the cytopathologist in both groups. -Time required in both groups. -Cost-effectivity of both approaches. -Number and nature of complications in both groups.

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Countries

Netherlands

Outcome results