Endoscopic Retrograde Cholangiopancreatography
Conditions
Keywords
duodenoscopes; ERCP
Brief summary
The aim of this randomized trial is to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the disposable (single-use) and reusable duodenoscopes.
Detailed description
Given the recent reports on infection outbreaks, including carbapenem-resistant Enterobacteriaceae (CRE), caused by contaminated duodenoscopes used at endoscopic retrograde cholangiopancreatography (ERCP), a disposable (single-use) duodenoscope (Exalt, Single-Use Duodenoscope, Boston Scientific Corporation, Natick, MA) has been developed to circumvent this issue. However, there are currently no data on the technical features and outcomes of disposable duodenoscopes, in comparison with reusable duodenoscopes. The aim of this randomized trial is therefore to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the two duodenoscope types.
Interventions
DEVICEendoscopic retrograde cholangiopancreatography
The duodenoscope will be passed to the duodenum in the standard fashion. Once the papilla has been identified in the duodenum, cannulation of the desired duct will be performed in the standard fashion, with the type of accessories used left to the discretion of the individual endoscopist performing the procedure. If cannulation is considered difficult, advanced cannulation techniques can be used per standard of care at the discretion of the individual endoscopist. The types of accessories used will be left to the discretion of the individual endoscopist and will be dependent on procedure indication and personal preference. Cross-over to the alternate duodenoscope type can be performed at any time if the desired technical maneuver cannot be performed with the designated duodenoscope.
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old 2. Patients with native papilla 3. Requiring an ERCP procedure for biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at computed tomography or magnetic resonance cholangiopancreatography
Exclusion criteria
1. Age \<18 years old 2. Unable to obtain informed consent 3. Pregnancy 4. Altered upper gastrointestinal surgical anatomy 5. Patients with percutaneous transhepatic biliary drainage catheters 6. Prior history of ERCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cannulation | 1 day | The ease of cannulation of the desired duct (biliary or pancreatic), as measured by the total number of cannulation attempts to achieve successful cannulation of the desired duct. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of completion of interventions | 1 day | Ease of completion of each step of the ERCP procedure, measured on a 5 point scale with 1 being the easiest and 5 being the most difficult. |
| Rate of use of advanced cannulation techniques | 1 day | Need for use of advanced cannulation techniques |
| Rate of cross-over | 1 day | Rate of cross-over to the alternate duodenoscope for completion of the procedure |
| Ease of passage of duodenoscope and imaging and mechanical function of the duodenoscope | 1 day | Ease of maneuverability of the duodenoscope to reach the major papilla, the imaging and mechanical function of the duodenoscope, measured on a five point scale with 1 being the easiest and 5 being the most difficult. |
| Total duration of the procedure | 1 day | Total duration of the procedure |
| Rate of adverse events | 7 days and 30 days | Assessment of AEs and SAEs |
| Time taken for cannulation | 1 day | Time taken for cannulation |
Countries
United States
Outcome results
None listed