Solid lesions of the gastrointestinal tract and adjacent organs under investigation with endosonography. Disease of pancreas, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Presence of a solid lesion measuring at least 1 cm Indication for Endosonography-Guided Fine Needle Aspiration-guided fine needle aspiration for tissue diagnosis Provision of written informed consent
Exclusion criteria
Exclusion criteria: Coagulopathy (INR greater than 1.5 or platelet count less than 50000) Use of anticoagulant medications that cannot be safely discontinued Presence of cystic lesions Prior EUS-Guided Fine Needle Aspiration of the same lesion Allergy or contraindication to heparin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sample adequacy. Timepoint: Assessing sample adequacy immediately after aspiration and preparing the sample in the same procedure session. Method of measurement: Assessment of the adequacy of the cellular sample by a pathologist based on microscopic examination of the prepared smears and the use of a zero to three scoring system to determine the degree of cellularity of the sample. | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic efficiency. Timepoint: After preparation and pathological examination of the specimen immediately after the procedure. Method of measurement: Based on the final report of the pathologist and the determination of whether or not a definitive diagnosis is made.;Complications associated with the procedure. Timepoint: 8 hours, 12 hours and 24 hours after the intervention. Method of measurement: Based on the patient's clinical assessment, physical examination, and review of paraclinical findings including tests and clinical symptoms such as bleeding, infection, and pancreatitis. | — |
Countries
Iran (Islamic Republic of)
Contacts
Shahid Beheshti University of Medical Sciences