Bio-degradable bile duct stent study
Research type
Research Study
Full title
Prospective observational cohort study: To assess the utility of bio-degradable bile duct stent in the drainage of bile duct.
IRAS ID
285192
Contact name
Suresh Vasan Venkatachalapathy
Contact email
Sponsor organisation
Nottingham University hospitals NHS trust.
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 27 days
Research summary
Research Summary
Endoscopic retrograde cholangio-pancreatogram (ERCP) is an endoscopic procedure done to establish either bile duct (Pipe that drains bile from liver) or pancreatic duct (Pipe that drains pancreatic juices in to small bowel) drainage or both. The intended benefits of the procedure are either to relieve bile duct/ pancreatic duct obstruction or facilitate bile duct/ pancreatic duct drainage.
The incidence of bile leak following gall bladder surgery is 0.5 to 1% and 4-7.2% following liver resection. Endoscopic management of bile leaks through ERCP is an accepted mode of treatment.
The incidence of gall stones is as high as 5-25%.The gall stones are made of cholesterol, pigment and mixture of cholesterol and pigment. ERCP and removal of these stones followed by an elective cholecystectomy (removal of gall bladder) at a later date is an accepted mode of treatment. However, because of the waiting time pressures, the average time for a patient to receive cholecystectomy is 12-16 weeks (local data). Patients are at risk of developing cholangitis (infection of bile duct) secondary to stones displacing from the gall bladder in to the bile duct. Hence, the endoscopist may place a plastic stent to minimise this risk. The stent will be removed at a later date after the surgery.
A novel bile duct stent has been introduced which has the added benefit of biodegradation to eliminate the need for subsequent removal hence the endoscopic procedures. The slow degrading stent may be suited for bile leaks post cholecystectomy/hepatic resection and in patients with stones in bile duct. We propose a prospective observational cohort that will assess whether biodegradable stents are effective in draining the bile ducts. The patients studied will be patients who are endoscopically treated for bile leak and patients who had bile duct stone removal but awaiting gall bladder removal.Summary of Results
64 Patients were included in analysis. The clinical success rate was 96.8% and it was feasible to deploy the stent in all patients. The visibility of the stent on fluoroscopy was excellent in 45(70%), good in 13(20%) and neutral in 5(8%) patients. Forty-three patients (88%) had complete degradation, 2(4%) had partial degradation, and 4(8%) had no degradation at 90 days. Patient quality of life increased by 17 fold amongst the bile leak cohorts compared to 13 fold amongst bile stone cohorts. Irrespective of the indications, quality of life measure improved by 14 folds during the follow up period. Bio-degradable stents are associated with higher clinical success rate, acceptable complication rate, and significant improvement in quality of life after the procedure to patients. It is associated with significant cost savings to health care providers by avoiding repeat procedures.REC name
Wales REC 4
REC reference
20/WA/0266
Date of REC Opinion
14 Oct 2020
REC opinion
Favourable Opinion