eedle-knife fistulotomy (NKF) for primary biliary access in patients with choledocholithiasis; a *real world* prospective multicenter pilot study

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

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

- 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 < 30 mL/min) and NSAID use for other indications (other than
cardioprotective aspirin)
- Coagulopathy or anticoagulant use, except for antiplatelet monotherapy
- Type I (flat papilla without oral protrusion) and type IIIA (papillary
orifice inside the diverticulum) according to the Viana classification (18),
and all others without an intraduodenal segment
- Active cholangitis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is safety and feasibility of NKF. Feasibility is defined as<br /><br>successful biliary cannulation via the fistulotomy. Safety is defined as<br /><br>absence of ERCP related complications (perforation, bleeding, post ERCP<br /><br>pancreatitis).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes will include:<br /><br>- Individual components of the primary endpoint<br /><br>- Clinical success<br /><br>- Successful CBD stone removal<br /><br>- PD cannulation/contrast injection<br /><br>- Time from first contact with the papilla until successful cannulation<br /><br>- Total cannulation time and total procedure time<br /><br>- Other ERCP-related adverse events, such as cholangitis, cholecystitis and<br /><br>abscess within 30 days<br /><br>- Mortality within 30 days<br /><br>- Objective structured assessment of technical skills (OSATS)<br /><br>- Association between OSATS based graded performance on ex vivo model and<br /><br>learning curve (as measured by procedural time and outcome) in patients</p><br>