None listed
Conditions
Brief summary
Endoscopic retrograde cholangiopancreatoscopy (ERCP) is a procedure that can assist in the treatment and diagnosis of liver disease as well as gallstone disease. Like all medical procedures, ERCP is associated with complications specifically infalmmation of the pancreas (pancreatitis). Pancreatitis is often associated with more difficult procedures that take longer than normal to complete. In these situations special techniques may be used to successfully complete the procedure, such as directly cutting into the drainage tube (bile duct)from the liver - this is called a needle knife cutting technique. This study looks at whether the use of this needle knife cutting technique may prevent or reduce the risk of pancreatitis complications if performed at an earlier stage.
Interventions
Needle knife sphincterotomy
This technique involves cutting through the duodenal mucosa directly into the bile duct rather than directly cannulating the bile duct via the anatomical opening (Ampulla of Vater). It involves the use of a needle knife - a thin stiff wire that cuts through the use of diathermy. Typically the needle knife technique takes between 1 - 10 minutes to gain access. Once used to gain access, it is not used again during the procedure.
Sponsors
Westmead Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Biliary indication for ERCP Naive biliary sphincter
Exclusion criteria
Absence of active pancreatitis Pancreatic malignancy Ampullary malignancy Previous sphincterotomy Haemodynamically instability
Outcome results
None listed