BACKGROUND: Endoscopic sphincterotomy (EST) is widely used to treat common bile duct stones (CBDS); however, long-term studies have revealed the increasing incidence of recurrent CBDS after EST. Loss of sphincter of Oddi function after EST was the main cause of recurrent CBDS. Reparation of the sphincter of Oddi is therefore crucial. This study aims to investigate the effectiveness and safety of endoclip papilloplasty (ECPP) for repairing the sphincter of Oddi and elucidate its mechanism. METHODS: Eight healthy Bama minipigs were randomly divided into the EST group and the ECPP group at a 1:1 ratio, and bile samples were collected before endoscopy and 6 months later. All minipigs underwent transabdominal biliary ultrasonography for the diagnosis of cholelithiasis 6 months after endoscopy. The biliary microbiota composition and alpha and beta diversity were analyzed by 16S ribosomal RNA gene sequencing. Differential metabolites were analyzed by bile acid metabolomics to explore the predictive indicators of cholelithiasis. RESULTS: Three minipigs were diagnosed with cholelithiasis in the EST group, while none in the ECPP group showed cholelithiasis. The biliary Firmicutes/Bacteroidota (F/B) ratio was increased after EST and decreased after ECPP. The Chao1 and observed species index significantly decreased 6 months after EST ( P  = 0.017 and 0.018, respectively); however, the biliary α-diversity was similar before and 6 months after ECPP. The β-diversity significantly differed in the EST group before and 6 months after EST, as well as in the ECPP group before and 6 months after ECPP (analysis of similarities [ANOSIM]: R  = 0.917, P  = 0.040; R  = 0.740, P  = 0.035; respectively). Glycolithocholic acid (GLCA) and taurolithocholic acid (TLCA) accumulated in bile 6 months after EST. CONCLUSIONS ECPP has less impact on the biliary microenvironment than EST and prevents duodenobiliary reflux by repairing the sphincter of Oddi. The bile levels of GLCA and TLCA may be used to predict the risk of cholelithiasis.
Animals ; Swine, Miniature ; Swine ; Cholelithiasis/prevention & control* ; Sphincterotomy, Endoscopic/methods* ; Sphincter of Oddi/surgery* ; Female ; Male

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.

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