To explore the safety and efficacy of NKF as the primary cannulation technique in patients with an indication for sphincterotomy in tertiary as well as teaching centers after standardized training on an ex-vivo ERCP model.
ID
Source
Brief title
Condition
- Bile duct disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Selective biliary cannulation is an essential first step in a successful
endoscopic retrograde cholangiopancreatography (ERCP). However, conventional
cannulation techniques fail in 5%-20% of cases.(1, 2) Difficult biliary access
leads to repeated cannulation attempts, mechanical injury to the papilla and/or
pancreatic duct cannulation.(3) Previous studies have reported that these
actions might facilitate the most common procedure-related adverse event,
post-ERCP pancreatitis (PEP). (4, 5)
In the last decades, various rescue methods have been developed to overcome the
issue of difficult biliary cannulation, such as precut sphincterotomy and
Needle-Knife Fistulotomy (NKF). As opposed to precut sphincterotomy, NKF
requires an incision a few millimetres above the papillary orifice without
trauma to the papilla.
Although NKF was initially developed as a rescue technique, it could reduce PEP
rates to zero if it would be used as primary biliary cannulation technique
instead of the standard technique. There is now considerable evidence to
support this hypothesis, with multiple RCTs showing low PEP rates (0 -
2.0%).(5-7) Despite these encouraging results in tertiary care centres, NKF as
primary technique has not been implemented in daily clinical practice. This is
probably due to lack of experience of this rescue technique and thereby not
feeling comfortable using it.
Study objective
To explore the safety and efficacy of NKF as the primary cannulation technique
in patients with an indication for sphincterotomy in tertiary as well as
teaching centers after standardized training on an ex-vivo ERCP model.
Study design
Prospective, multicenter, single-arm, interventional pilot study.
Intervention
needle-knife fistulotomy as primary cannulation technique after hands-on
training on an ex-vivo ERCP model provided by the researchers.
Study burden and risks
Because this technique requires an incision above the papilla, direct contact
with the pancreatic duct is avoided, reducing the risk of post-ERCP
pancreatitis. Apart from this alternative method of primary biliary
cannulation, they receive standard care.
Boelelaan 1117
Amsterdam 1081HV
NL
Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86953.018.24 |