Solid Lesion Biopsies Clinical Trial
Official title:
Prospective Study Comparing the Diagnostic Yield of Solid Lesion Biopsies Performed by EUS-FNA Using the 25d ProCor Needle Versus the Standard 25g Needle.
| Verified date | May 2020 |
| Source | Centre hospitalier de l'Université de Montréal (CHUM) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Background: There is an ongoing interest in developing Endoscopic Ultrasound /Fine Needle Aspiration (EUS-FNA) needles that can provide tissue core biopsies for a true histological (rather than cytological) evaluation. By slightly modifying the traditional EUS-FNA needle, a new needle named "ProCor" was developed in the hope of obtaining core samples and thus increase diagnostic yield. Objective: In this research project, we propose to conduct a prospective trial to compare the results obtained with two types of needles: a 25g standard needle (25gS) and the 25g ProCor needle (25gP). EUS-FNA Biopsies will be obtained with both the 25S and 25P needles in each lesion; a randomisation sequence will set in order to determine which of the two needles will first be used (25S or 25P). The cytological or histological diagnoses will be made; . for histological diagnosis, the pathologist will first establish the presence or absence of a tissue core (defined as a measurable cylinder of tissue). The pathologist will assess the adequacy of each specimen: cellularity (score 1 "poor"; score 2 "good"; score 3 "excellent"),[14] sample bloodiness (score 1 "minimal";score 2 "moderate"; score 3 "significant", and the presence or absence of malignancy("positive" / "negative" / "suspicious" / inconclusive). Results for continuous variables will be summarized using mean ± SD, . and categorical variables using proportions. The 25S and 25P groups will be compared using Chi-square test for categorical variables and, Student t test for continuous variablesTwo-sided p values less than 0.05 will be considered statistically significant. Data will be analyzed using SPSS v 15.0 (SPSS Inc., Chicago IL) statistical software.
| Status | Completed |
| Enrollment | 224 |
| Est. completion date | September 15, 2020 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Age: = 18 years old - Patients presenting with a solid lesion - Patients for whom EUS-FNA is considered clinically indicated and safe Exclusion Criteria: - Age < 18 years old, - Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis or other lesions in which a large amount of tissue will be required for diagnosis, - Patients with significant coagulopathy (INR>1.5, platelets <50000/mm3, use of low molecular weight heparin, use of clopidogrel within 7 days of EUS), Patients presenting with cystic lesions Inability or refusal to sign the informed consent. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal) | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Compare the diagnostic yield of biopsies performed EUS-FNA by using the 25d ProCor needle versus the standard 25g needle | 1 day | ||
| Secondary | Measurement of the size of the "core" samples produced by the two types of needles | 1 day | ||
| Secondary | Measurement of incidence and severity of immediate complications associated with the two types of needles | Immediate complications will be assessed and recorded by nurses and/or physicians during and after the procedure while the patient was recovering from sedation. | 1 day |