Description of Event or Problem · 0
LINEAR ARRAY ECHOENDOSCOPE (OLYMPUS GF-UCT180; OLYMPUS AMERICA, INC, CENTER VALLEY, PA) AFTER ADMINISTRATION OF PROPOFOL USING 1 OF 4 FNB (22G) NEEDLES (PROCORE; COOK ENDOSCOPY, WINSTON-SALEM, NC; EZ SHOT 3 PLUS; OLYMPUS AMERICA, INC; ACQUIRE; BOSTON SCIENTIFIC CORPORATION, MARLBOROUGH, MA; OR SHARKCORE; MEDTRONIC, SUNNYVALE, CA) BY 1 OF 4 EXPERIENCED ENDOSONOGRAPHERS (>750 EUS PROCEDURES/Y). THE 4 NEEDLE-TIP DESIGNS ARE SHOWN IN SUPPLEMENTARY FIGURE 1 AND THEIR GEOMETRIES ARE DESCRIBED IN THE SUPPLEMENTARY APPENDIX. DURING EUS FNB, THE STYLET WAS REMOVED AFTER PUNCTURING THE PANCREATIC MASS, AND SAMPLED USING THE FANNING TECHNIQUE (4 STROKES AT 4 LOCATIONS WITHIN THE MASS) (SUPPLEMENTARY VIDEO 1). DETAILS OF INDIVIDUAL SAMPLING TECHNIQUES ARE INCLUDED IN THE SUPPLEMENTARY APPENDIX. THREE DEDICATED PASSES WERE PERFORMED USING THE ASSIGNED NEEDLE: 1 PASS FOR EACH OF THE 3 TECHNIQUES, WITH THE ORDER OF THE TECHNIQUE DETERMINED BY THE RANDOMIZATION SEQUENCE. THE TISSUE SPECIMENS FROM EACH PASS WERE COLLECTED SEPARATELY IN 10% FORMALIN FOR TISSUE ANALYSIS. DETAILS ON THE METHOD OF TISSUE PREPARATION AND HISTOLOGIC ASSESSMENT ARE INCLUDED IN THE SUPPLEMENTARY APPENDIX. TO LIMIT SUBJECTIVE INTERPRETATION, SPECIMENS WERE QUANTIFIED USING SPECIALIZED IMAGE ANALYZING SOFTWARE (NIKON DS-FI2 COLOR CAMERA AND NIS-ELEMENTS BASIC RESEARCH SOFTWARE VERSION 4.5; NIKON INSTRUMENTS, INC, MELVILLE, NY) THAT MEASURED THE TOTAL SPECIMEN AREA, CORE TISSUE (ACINAR AND DUCTAL CELLS, FIBROSIS, AND TUMOR WHEN APPLICABLE), BLOOD, AND CRUSH ARTIFACT.6,7 THIS BASIC RESEARCH IMAGING SOFTWARE HAS BEEN USED PREVIOUSLY IN OTHER MEDICAL SPECIALTIES TO EVALUATE AND QUANTIFY TISSUE MORPHOLOGY.14¿16 IMMEDIATE ADVERSE EVENTS WERE DOCUMENTED AT THE TIME OF THE PROCEDURE AND LATE ADVERSE EVENTS BY TELEPHONE FOLLOW-UP EVALUATION AT 7 AND 30 DAYS AFTER THE PROCEDURE. THIS COMPLAINT CAPTURES 1 X CASE POSTPROCEDURAL ABDOMINAL PAIN, REQUIRING ADMISSION FOR OBSERVATION FOR 1 DAY.