Single Use ERCP -SURE Study

Summary

Participation Requirements

Description

ERCP is a therapeutic endoscopic procedure done to establish either bile duct or pancreatic duct drainage or both. The indications for ERCP are bile duct stones, bile duct strictures, sphincter of Oddi manometry with sphincterotomy, bile leak, pancreatic duct stones and pancreatic duct stricture. Th...

ERCP is a therapeutic endoscopic procedure done to establish either bile duct or pancreatic duct drainage or both. The indications for ERCP are bile duct stones, bile duct strictures, sphincter of Oddi manometry with sphincterotomy, bile leak, pancreatic duct stones and pancreatic duct stricture. The intended benefits of the procedure are either to relieve bile duct/ pancreatic duct obstruction or facilitate bile duct/ pancreatic duct drainage. It is a minimally invasive procedure and is associated with reduced morbidity compared to surgery. Gall stones are made of cholesterol, pigment and mixture of cholesterol and pigment. The incidence of stones with in the bile-duct varies from 4.6% to 19%.The stones are predominantly formed in the gall bladder and are displaced from the gall bladder in to the bile duct via the cystic duct. ERCP is an effective and minimally invasive treatment for bile duct stones. Treatment of extra- hepatic biliary strictures; irrespective of their aetiology, is to place a stent across the stricture through ERCP and facilitate biliary drainage. There is emerging data that the incidence of carbapenem resistant enterobacteriae, Multidrug-resistant Klebsiella pneumoniae, and New Delhi metallo-?-lactamase-producing carbapenem-resistant Escherichia coli (CRE) following exposure to contaminated duodenoscopes (ERCP endoscopes). The main reason for the outbreaks is due to inadequate reprocessing (Cleaning of endoscope post procedure) leading to contamination of endoscpes. To minimise the risk of contamination and outbreak of above infections, single use disposable duodenoscopes have been brought in to the market. The aim of the study is to assess the performance of the single use duodenoscope against the standard reusable duodenoscope and the cost consequences associated with the above.

Tracking Information