choledocholithiasis gallstones
Conditions
Interventions
needle-knife fistulotomy as primary cannulation technique after hands-on
training on an ex-vivo ERCP model provided by the researchers.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with an indication for ERCP with sphincterotomy (e.g. choledocholithiasis) - Sedation with administration of propofol or general anesthesia during ERCP - Naive papilla - Capable of written informed consent - Age >= 18 years
Exclusion criteria
Exclusion criteria: - Low risk of pancreatitis: (1) definite chronic pancreatitis according to M-ANNHEIM criteria (15), (2) previous sphincterotomy, and (3) routine biliary stent exchange. In case of a pancreatic duct intervention, chronic pancreatitis and previous sphincterotomy are not exclusion criteria - Acute pancreatitis, according to the Atlanta classification - Altered anatomy (defined as anatomical variations in which bile and/or pancreatic secretions (in case of pancreatic duct interventions) do not enter the duodenum by way of the ampulla of Vater (e.g., Roux-en-Y reconstruction, surgery for chronic pancreatitis) - Pregnancy - Severe liver disease (ascites) - Contraindications for rectal NSAIDs, including allergy, active gastrointestinal bleeding, ulcer disease, renal insufficiency (glomerular filtration rate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is safety and feasibility of NKF. Feasibility is defined as successful biliary cannulation via the fistulotomy. Safety is defined as absence of ERCP related complications (perforation, bleeding, post ERCP pancreatitis). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include: - Individual components of the primary endpoint - Clinical success - Successful CBD stone removal - PD cannulation/contrast injection - Time from first contact with the papilla until successful cannulation - Total cannulation time and total procedure time - Other ERCP-related adverse events, such as cholangitis, cholecystitis and abscess within 30 days - Mortality within 30 days - Objective structured assessment of technical skills (OSATS) - Association between OSATS based graded performance on ex vivo model and learning curve (as measured by procedural time and outcome) in patients | — |
Countries
Netherlands
Outcome results
None listed