To further demonstrate the toxicity of the catheter, cytotoxicity evaluation was conducted in registration inspection products and the relationship between testing methods and materials were analyzed. This result showed that to strengthen cytotoxicity assay in registration inspection is important to choose catheter in clinic.
Cells, Cultured ; Cytotoxins ; toxicity ; Disposable Equipment ; Humans ; Materials Testing ; Urinary Catheters ; adverse effects

Objective:To evaluate the efficacy and safety of enteral extended biliary stenting for biliary stricture.Methods:A multicenter retrospective cohort study was conducted on data of 550 patients with obstructive jaundice due to extrahepatic bile duct stricture between February 2006 and April 2020. Patients were assigned to conventional group (undergoing conventional biliary stent placement) and extended group (undergoing enteral extended biliary stent placement). Propensity score was used to match the basic data of patients of the two groups. Then the stent patency time, bilirubin difference before and after 1 week operation, incidence of complications and hospital stay were compared between the two groups.Results:Among the 550 patients, clinical data of 20 cases were missing and 35 failed to be followed up. Finally, 326 patients were enrolled to the study after propensity score matching with 163 cases in each group. The patency time of extended group was 111.0 (82.0, 192.0) days, which was longer than that of conventional group with patency time of 93.0 (70.0, 141.8) days ( Z=3.260, P=0.001). Total bilirubin difference value of pre-operation and post-operation was less in extended group [51.2 (26.0, 114.7) μmol/L VS 46.0 (13.9, 81.1) μmol/L, Z=2.095, P=0.036]. The rate of early adverse events [4.3% (7/163) VS 3.7% (6/163), P=0.079] and median in-patient days (10.0 days VS 10.0 days, P=0.379) were similar in the two groups. Conclusion:Enteral extended biliary stent is effective and safe for treatment of biliary stricture, which can prolong the patency time without increasing postoperative complications and hospital stay.