Description of Event or Problem · 0
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "PERFORMANCE OF ENDOSCOPIC ULTRASOUND-GUIDED VERSUS PERCUTANEOUS LIVER BIOPSY IN DIAGNOSING STAGE 3¿4 FIBROSIS." LITERATURE SUMMARY: THIS RETROSCPECTIVE STUDY AIMED TO EVALUATE IF EUS-BX, COMPARED TO P-BX, CAN EFFECTIVELY AND SAFELY OBTAIN ADEQUATE SPECIMEN AND ACCURATELY PREDICT HEPATIC FIBROSIS. THIS IS A SINGLE CENTER, RETROSPECTIVE CHART REVIEW AMONG PATIENTS WITH LIVER DISEASES AT A TERTIARY ENDOSCOPY CENTER FROM FEBRUARY 2011 TO MARCH 2020. WE ASSESSED THE EUS-BX VERSUS P-BX OUTCOMES BY SUCCESS RATE, PERFORMANCE, AND SAFETY PROFILE. THE PRIMARY OUTCOME WAS THE ASSOCIATION BETWEEN EUS-BX CLINICAL VARIABLES AND THE PRESENCE OF HISTOLOGIC LIVER FIBROSIS STAGE = 3. THE SECONDARY OUTCOMES WERE THE ASSOCIATIONS BETWEEN EUS-BX AND VARIABLES INDICATIVE OF FIBROSIS. RESULTS FIFTY-NINE PATIENTS UNDERWENT EUS-BX; AND 59, P-BX. ALL EUS-BX PROCEDURES WERE SUCCESSFULLY COMPLETED. ALL 56/56 (100%) OF EUS-BX VS. 50/52 (96.2%) P-BX WERE CONSIDERED ADEQUATE SAMPLES. TISSUE LENGTHS WERE SIGNIFICANTLY LONGER IN THE EUS-BX COHORT (P < 0.0001) WITH A TREND TOWARDS A GREATER NUMBER OF PORTAL TRACTS. 46/56 (82.1%) CASES OF EUS-BX VS. 32/52 (61.5%) OF P-BX HAD > 10 PORTAL TRACTS; 21/56 (37.5%) CASES OF EUS-BX VS. 14/52 (26.9%) OF P-BX HAD > 15 PORTAL TRACTS. THERE WERE 6 (10.2%) EUS-BX VS. 1 (1.7%) P-BX RELATED COMPLICATION LEADING TO A PHONE CALL (P = 0.061). RESULTS: FIFTY-NINE PATIENTS UNDERWENT EUS-BX; AND 59, P-BX. ALL EUS-BX PROCEDURES WERE SUCCESSFULLY COMPLETED. ALL 56/56. (100%) OF EUS-BX VS. 50/52 (96.2%) P-BX WERE CONSIDERED ADEQUATE SAMPLES. TISSUE LENGTHS WERE SIGNIFICANTLY LONGER IN. THE EUS-BX COHORT (P < 0.0001) WITH A TREND TOWARDS A GREATER NUMBER OF PORTAL TRACTS. 46/56 (82.1%) CASES OF EUS-BX VS. 32/52 (61.5%) OF P-BX HAD > 10 PORTAL TRACTS; 21/56 (37.5%) CASES OF EUS-BX VS. 14/52 (26.9%) OF P-BX HAD > 15 PORTAL TRACTS. THERE WERE 6 (10.2%) EUS-BX VS. 1 (1.7%) P-BX RELATED COMPLICATION LEADING TO A PHONE CALL (P = 0.061). CONCLUSIONS EUS-BX CAN SAFELY PERFORMED AND ACCURATELY PREDICT LIVER FIBROSIS STAGE AS THE STANDARD P-BX WITHOUT BEING INFLUENCED BY PROCEDURE-RELATED FACTORS. CONCLUSIONS: EUS-BX CAN SAFELY PERFORMED AND ACCURATELY PREDICT LIVER FIBROSIS STAGE AS THE STANDARD P-BX WITHOUT BEING INFLUENCED BY PROCEDURE-RELATED FACTORS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: 2 PATIENTS ON EUS-BX VERSUS ZERO PERCUTANEOUS LIVER BIOPSY COMPLICATION LED TO AN ER VISIT 2 PATIENTS ON EUS-BX VERSUS ZERO PERCUTANEOUS LIVER BIOPSY COMPLICATION LED TO A HOSPITALIZATION FOR OBSERVATION. 1 PATIENT WHO UNDERWENT EUS-BX HAD THROMBOCYTOPENIA WITH PLATELET COUNT OF 101 × 10**9/L,(STAGE 3 FIBROSIS, WHO CALLED, WAS ADVISED TO PRESENT TO THE ER, AND WAS EVALUATED AND SENT HOME WITHOUT HOSPITALIZATION. THIS LITERATURE ARTICLE REQUIRES 3 REPORTS: 1) (B)(6)-ULTRASONIC GASTROVIDEOSCOPE, MODEL- GF-UC140P-AL5, SN-UNK. 2) (B)(6)-- ULTRASONIC GASTROVIDEOSCOPE- MODEL -GF-UC140P-AL5- SN -UNK (FOR GF-UC180P-AL5 IN THE LITERATURE) AS A REPRESENTATIVE PRODUCT WITH THE SAME PROCODE). 3) (B)(6) - SINGLE USE ASPIRATION NEEDLE NA-U200H NA-U200H-8019, SN-UNK. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER: (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.