None listed
Conditions
Brief summary
Endoscopic retrograde cholangiopancreatography has been the standard of care for the management of bile blockage. This procedure combines the use of x-rays and an endoscope (a long, flexible, lighted tube). During the procedure, the doctor can see the inside of the stomach and small intestine, and inject dye into the drainage tubes (ducts) of the pancreas or bile to see them more clearly on x-ray. However, this procedure is not always possible or successful due to altered anatomy related to surgery or disease related causes. Percutaneous transhepatic biliary drainage has been used as an alternative in these cases. During this procedure a tube to drain the bile ducts is introduced through the skin and liver. However, this procedure is associated with a number of complications such as bile leak, peritonitis, tube dislodgement, recurrent infection and bleeding. Endoscopic ultrasound is another procedure that uses sound waves to create visual images of the digestive tract, including the liver, bile ducts and pancreas. This procedure provides real time images and access to organs which are inaccessible by other means. Endoscopic ultrasound guided bile drainage is not a new procedure: several studies have looked at the safety and efficacy of this procedure in the management of bile blockage, however more studies are needed. This study aims to determine the efficacy and safety of bile drainage via endoscopic ultrasound for benign blockage when endoscopic X-ray procedure was unsuccessful. Data collected in the study will help to understand if endoscopic ultrasound is an equivalent or is better for bile drainage than a procedure performed introducing a tube via the skin into the bile duct.
Interventions
Interventional endoscopists who have performed numerous and various interventional endoscopic ultrasound procedures both locally and internationally, have trained overseas and attended courses on interventional endoscopic ultrasound will perform endoscopic ultrasound guided biliary drainage of benign biliary strictures by creating a fistula between the bile duct and stomach or duodenum using removable self expanding metal stents, face to face on patients with benign biliary strictures in a terti
Interventional endoscopists who have performed numerous and various interventional endoscopic ultrasound procedures both locally and internationally, have trained overseas and attended courses on interventional endoscopic ultrasound will perform endoscopic ultrasound guided biliary drainage of benign biliary strictures by creating a fistula between the bile duct and stomach or duodenum using removable self expanding metal stents, face to face on patients with benign biliary strictures in a tertiary hospital. The average duration of the procedure is 40 minutes. Only one stent will be used for the study but if the stent to be placed becomes obstructed, then another stent will be placed. Blood samples will be taken to assess liver function on Day 2, week 2, month 1 then monthly unto 12 months post procedure.
Sponsors
Payal Saxena
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with obstructive jaundice secondary to benign biliary strictures for biliary drainage who have failed ERCP to access the bile duct because of failed cannulation and surgically altered anatomy requiring double balloon enteroscopy guided ERCP and who refuse percutaneous trans biliary drainage
Exclusion criteria
Patients who are pregnant, who have bleeding tendency defined as having a platelet less than 50,000 or INR >1.5, PTT >50 seconds and malignant biliary strictures
Outcome results
None listed