Olympus medical systems corp.(omsc) received a literature titled "fluorescence in situ hybridization in primary diagnosis of biliary strictures: a single-center prospective interventional study." background and aims: diagnosis of the biliary stricture remains a challenge.In view of the low sensitivity of brush cytology (bc), fluorescence in situ hybridization (fish) has been reported as a useful adjunctive test in patients with biliary strictures.We aimed to determine performance characteristics of bc and fish individually and in combination (bc + fish) in the primary diagnosis of biliary strictures.Methods: this single-center prospective study was conducted between april 2019 and january 2021.Consecutive patients with unsampled biliary strictures undergoing first endoscopic retrograde cholangiopancreatography in our institution were included.Tissue specimens from two standardized transpapillary brushings from the strictures were examined by routine cytology and fish.Histopathological confirmation after surgery or 12-month follow-up was regarded as the reference standard for final diagnosis.Results: of 109 enrolled patients, six were excluded and one lost from the final analysis.In the remaining 102 patients (60.8% males, mean age 67.4, range 25¿92 years), the proportions of benign and malignant strictures were 28 (27.5%) and 74 (72.5%), respectively.The proportions of proximal and distal strictures were 26 (25.5%) and 76 (74.5%), respectively.In comparison to bc alone, fish increased the sensitivity from 36.1% to 50.7% (p = 0.076) while maintaining similar specificity (p = 0.311).A total of three patients developed mild post-ercp pancreatits (pep).Per literature definition, pep with a short hospitalization were considered as mild complications.There were no lethal or severe complications related to the study methods.Supplementary table s3 shows the demographic parameters of the patients who died during the follow-up.During the study period, 11 (10.8%) patients died.This includes 10 (90.9%) with malignant strictures and one patient who was a 73-year-old male with chronic pancreatitis and a stenosis of the distal bile duct who died after six months of lung cancer.Conclusions: dual-modality tissue evaluation using bc + fish showed an improving trend in sensitivity for the primary diagnosis of biliary strictures when compared with bc alone.Patient identifiers: (b)(6) :tjf-q180v, pep, (b)(6) :tjf-q190v, pep, (b)(6) :bc-v600p-3010, pep, (b)(6) : tjf-q180v, 10 deaths, (b)(6) : tjf-q190v, 10 deaths, (b)(6) : bc-v600p-3010, 10deaths, (b)(6): tjf-q180v, death of the 73 year old, (b)(6) : tjf-q190v, death of the 73 year old, (b)(6) : bc-v600p-3010, death of the 73 year old.This report is for (b)(6).
|
This report is being supplemented to provide additional information from the author and additional information based on the legal manufacturer's final investigation.Updated b5 to reflect the additional information received.Since the actual product was not sent, it was presumed that it was not caused by a product defect, but were unable to identify the cause.Since the lot number/manufacturing number of the device used is unknown, the manufacturing records cannot be investigated, but olympus conducts inspections and only ships products that pass the inspections.Olympus will continue to monitor field performance for this device.
|