Pancreatic Solid Lesions Clinical Trial
Official title:
Stylet Slow-Pull Technique Compared To Standard Suction For Endoscopic Ultrasound-Guided Fine-Needle Biopsy In Pancreatic Solid Lesions: Data From A National Multicenter Randomized Trial
NCT number | NCT03849209 |
Other study ID # | 1270 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | May 31, 2018 |
Verified date | February 2019 |
Source | ARNAS Civico Di Cristina Benfratelli Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Ultrasound-guided fine-needle aspiration represents the gold-standard for the pathological diagnosis of solid pancreatic lesions. New needles design allowed to obtain samples suitable for histological evaluation (endoscopic ultrasound-guided fine needle biopsy). the aim was to compare two different techniques during ultrasound-guided fine needle biopsy, for diagnosis of suspect pancreatic solid lesions.
Status | Completed |
Enrollment | 110 |
Est. completion date | May 31, 2018 |
Est. primary completion date | May 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age >18years old - Solid pancreatic lesion on imaging MRI and/or CT-scan referred for tissue acquisition - Lesion can be visualized with EUS and needle puncturing can be technically feasible - Able to sign informed consent Exclusion Criteria: - < 18 years-old - Cystic pancreatic lesions - Extra-pancreatic lesions or inaccessible/non-visualized lesions - Previous gastrectomy - International normalized ratio > 1.5 - Impossibility to suspend anticoagulant therapy - Platelet count < 50.000 cells/cubic millimeter - Severe or unstable clinical conditions - Pregnancy - Inability to give informed consent - Refusal to participate to the study |
Country | Name | City | State |
---|---|---|---|
Italy | ARNAS Civico - Di Cristina - Benfratelli Hospital | Palermo |
Lead Sponsor | Collaborator |
---|---|
ARNAS Civico Di Cristina Benfratelli Hospital |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of blood contamination of samples after endoscopic ultrasound-guided fine needle biopsy of pancreatic mass | Blood contamination of the specimen was considered significant (large amount of blood cells made pathological diagnosis difficult) or not-significant (no/few blood cells without influence on the pathological diagnosis) based on the pathologist evaluation of the formalin fixed and paraffin embedded (FFPE) tissue samples | 7 days | |
Primary | Diagnostic accuracy of samples obtained after endoscopic ultrasound-guided fine needle biopsy of pancreatic mass | Diagnostic accuracy was defined as the ratio between the sum of true positive and true negative values divided by the total number of masses. Sensitivity was defined as the true positive rate whereby the test was the final cytologic diagnosis. Specificity, positive predictive value (PPV), negative predictive value (NPV) were also evaluated. | up to 6 months | |
Secondary | Technical success of the procedure after endoscopic ultrasound-guided fine needle biopsy of pancreatic mass | Technical success was defined as the presence of a visible core, according to endosonographer's judgment, potentially useful for the final pathological analysis. | 5 minutes |
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