Safety and efficacy of biodegradable biliary and pancreatic stents

To assess the feasibility and safety performance of the novel bio-degradable stent (ARCHIMEDES) in these three groups: 1. Duct to duct anastomotic stricture (20 patients) 2. Hepaticojejunal strictures (20 patients) 3. Post-ERCP pancreatitis prophylaxis (20 patients) Patients referred to the investigators who meet the selection criteria will be invited to participate in this study. Prior to the study commencement the patient will be reviewed either by the transplant team or an interventional gastroenterologist in order to confirm the indication for the procedure (for duct to duct anastomotic stricture and hepaticojejunal stricture). The procedures will be conducted by consultant gastroenterologists and fellow who have qualifications in ERCP and accredited by the Conjoint Committee for the Recognition of Training in Gastrointestinal Endoscopy (CCRTGE). Prior to study commencement, all endoscopists will receive a standardised 60-minute training module reviewing the study protocol, methods and data recording. The training module is designed specifically for this study. The study protocol will be available at the study centre. Eligible patients will be approached and have the study explained to them by an investigator and be provided with a Patient Information Sheet. If an outpatient, they will be provided with at least 1 week to consider participation in the study. Inpatients will be given up to 24 hours to consider participation. Their surgery will proceed as planned regardless of their study participation. The consenting process will be carried out by a medical officer who is a researcher and independent from the attending medical team. Post ERCP and biliary stent placement (groups 1 and 2), patients will undergo liver function tests at • week 1 • week 2 • 1 month • 3 months • 6 months • 9 months • 12 months Abdominal X-ray will be performed to ensure complete stent degradation at: • 1 month • 3 months • 6 months Endoscopic procedure All endoscopic procedures will be performed with propofol-based deep sedation or general anaesthetic, with a consultant anaesthetist. A standard duodenoscope (Olympus, Japan) will be used for all procedures. Rectal indomethacin will be administered in patients where it is considered to be necessary (to prevent post procedure pancreatitis). Group 1 Biliary cannulation will be performed with standard short guidewire and sphincterotome. If necessary, a sphincterotomy will be conducted. Prior to placement the biodegradable stent will be pre-activated by immersion in sterile saline for one minute. Insertion is performed over a guidewire through the working channel of the duodenoscope using a standard ERCP catheter. Insertion will be done under radiologic visualization. A cholangiogram will be obtained. In patients with duct-to-duct biliary reconstruction, the stricture will be dilated with the aim to place stents to total diameter of 16Fr – 20Fr (2 x 8Fr stents or 10Fr). The stent size and number chosen will be determined based on findings at cholangiogram during ERCP. If the patient has undergone liver transplant within 8 weeks of ERCP, dilatation will not be performed and only a single stent will be placed. Total procedure time will be roughly 30 minutes. Group 2 In patients with hepaticojejunostomies, double balloon ERCPs will be performed with a double balloon enteroscope (Fujinon, Japan) and dilations of the anastomosis will be carried out with the aim of placing stents up to 16 - 20Fr in diameter (again the size and number will be chosen based on findings at cholangiogram). If the patient has undergone liver transplant within 8 weeks of ERCP, dilatation will not be performed and only a single stent will be placed. Total procedure time will be roughly 60 minutes. Group 3 In patients undergoing ERCP where a pancreatic stent is required for PEP prophylaxis (as per endoscopist discretion), a 6Fr pancreatic stent will be deployed. Total procedure time will be roughly 30 minutes.