Pancreatic Neoplasm Clinical Trial
Official title:
Single Center Randomized Clinical Trial to Evaluate the Histological and Diagnostic Accuracy of Two EUS Fine Needles Biopsy for the Diagnosis of Solid Pancreatic Lesions
Verified date | January 2021 |
Source | Azienda Ospedaliera Universitaria Integrata Verona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rationale: Until now there are no prospective studies comparing the 22 gauge and 25 gauge side-fenestrated and fork-tip needles. In the present study we will compare the two types of needles in terms of histological yield for the evaluation of solid pancreatic lesions in the absence of rapid on-site evaluation (ROSE). Moreover diagnostic accuracy and the number of passes necessary to achieve the maximum diagnostic and histological yield, and safety will be investigated. Objectives: To evaluate and compare the histologic retrieval rate of two different EUS-FNB needles of the same caliber (22 or 25 gauge). The passes will be 3 for each patient. Study design: Randomized monocentric trial. Study population: Patients ≥18 years old, referred for EUS-guided tissue sampling of a solid pancreatic mass. Intervention: EUS-guided tissue acquisition by mean EUS-FNB, using one of the following FNB needles: side-fenestrated 22 gauge, side-fenestrated 25 gauge, fork-tip 22 gauge or fork-tip 25 gauge. Main study parameters/endpoints: The main endpoint is the histologic yield (defined as the percentage of a tissue core of at least 550 micron at the greatest axis), obtained at each of the 3 needle passes. Secondary endpoints include: i) safety; ii) concordance between macroscopic on-site evaluation (MOSE) and histopathological evaluation ; iii) Accuracy using 1, 2 or 3 passes.
Status | Completed |
Enrollment | 192 |
Est. completion date | August 30, 2020 |
Est. primary completion date | December 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Solid pancreatic mass referred for EUS-guided tissue acquisition. - Written informed consent. Exclusion Criteria: - Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP). - Cystic lesions even with solid component. - Previous inclusion in present study. - Previous histological or cytological diagnosis. - Pancreatic lesion not seen at EUS. - Technical impossibility to perform EUS-FNB (for example, for the interposition of vessels). - Patients in an emergency situation. - Pregnancy or feeding time. |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Integrata Verona | Verona | |
Italy | Stefano Francesco Crinò | Verona |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria Integrata Verona |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EUS-FNB procurement yield of tissue "core" using two different FNB needles. | Procurement percentage of a "core" (defined as a piece of tissue at least 550 micron in the greatest axis) in the two arms. | 6 months | |
Secondary | Diagnostic accuracy. | Diagnostic accuracy (defined as the ratio between the sum of true positive and true negative values divided by the number of lesions) will be calculated for each study arm. | 6 months | |
Secondary | Diagnostic accuracy according to the number of needle passes | Diagnostic accuracy (defined as the ratio between the sum of true positive and true negative values divided by the number of lesions) will be calculated after 1, 2 or 3 needle passes in the two study arms. | 6 months | |
Secondary | Histologic retrieval rate according to the number of needle passes | Percentage of tissue core (defined as an intact piece of tissue of at least 550 micron in the greatest axis) will be calculated after 1, 2 or 3 needle passes in the two study arms. | 6 months | |
Secondary | Procedure related adverse events | Percentage of intra-procedural and post-procedural adverse events in the 2 arms (e.g haemorrhage, perforation, pancreatitis) will be compared. | 6 months | |
Secondary | Procedure related serious adverse events. | Percentage of serous adverse events in the 2 arms (e.g long hospitalization, disability, death) will be compared. | 6 months | |
Secondary | Samples tissue integrity | Tissue integrity will be evaluated by attributing a score from zero to 6 (6 represents the better outcome), according to the following score system:
0=Insufficient material for interpretation. 1=Sufficient material for limited cytological interpretation; probably not representative. 2=Sufficient material for adequate cytological interpretation. 3=Sufficient material for low quality histological interpretation (tissue fragments < 550 micron in greatest axis). 4=Sufficient material for good quality histological interpretation (1 to 5 cores > 550 micron in greatest axis). 5=Sufficient material for high quality histological interpretation (6 to 10 cores > 550 micron in greatest axis). 6=Sufficient material for excellent quality histological interpretation (more than 10 cores > 550 micron in greatest axis or total tissue length > 5.500 micron); |
6 months | |
Secondary | Samples blood contamination | Blood contamination will be evaluated by attributing a score from 0 to 3 (3 represents the better outcome), according to the following score system:
0=Only blood; 1=Much blood contamination, surface area > 50 % of the slide; 2=Medium blood contamination, surface area 25-50 % of the slide; 3=Little blood contamination, surface area < 25 % of slide. |
6 months | |
Secondary | Macroscopic on-site evaluation (MOSE) | Concordance between presence of a core at Macroscopic on-site evaluation (MOSE) and presence of core at histopathological evaluation. | 6 months |
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