Comparison of Outcomes in Patients Undergoing Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) Using Duodenoscope With Single-use Distal Cover and Conventional Reusable Duodenoscope: A Randomized Controlled Trial
Phase: NA
Conditions: Biliary Disease, Pancreatic Disease, Choledocholithiasis, Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Neoplasms
Sponsor: Stanford University

 
 
 
 
Comparison of Outcomes in Patients Undergoing Endoscopic 
Retrograde Cholangiopancreatoscopy (ERCP) Using 
Duodenoscope with Single-use Distal Cover and Conventional 
Reusable Duodenoscope: A Randomized Controlled Trial   
 
Study Protocol and Statistical Analysis Plan 
NCT05429203 
September 22, 2022 

Background and Rationale 
Over the past decade, multiple outbreaks of infections due to drug-resistant organisms have been 
traced to contaminated conventional reusable duodenoscopes. While lapses in reprocessing protocols 
may contribute, the inherent design of reusable duodenoscopes has also been implicated. 
Despite enhanced reprocessing guidelines issued by the FDA, persistent contamination remains a 
concern. Studies report that 3–5% of duodenoscopes continue to yield positive cultures even after 
reprocessing. In response, duodenoscope manufacturers have introduced models with disposable distal 
end caps (DDEC) intended to improve reprocessing efficacy and reduce infection risk. 
However, these DDEC duodenoscopes have been linked with specific adverse events such as 
detachment of the distal cap, rigidity, scope fracture, contamination, imaging issues, and functional 
failure. To date, no large-scale or long-term comparative study has evaluated procedure success and 
complication rates between DDEC and conventional reusable duodenoscopes (CRD). 
 
Study Objective 
To compare: 
• 
Procedure-related complication rates (primary outcome) 
• 
Procedure success rates and technical performance characteristics (secondary outcomes) 
in patients undergoing ERCP with either DDEC or CRD. 
 
Study Design 
• 
Design Type: Prospective, randomized controlled trial 
• 
Sample Size: 600 patients (300 per group) 
• 
Setting: Stanford Hospital Endoscopy Unit 
• 
Randomization: Block randomization with equal allocation 
• 
Follow-Up: Phone calls at 1 week, 1 month, and 3 months to assess delayed complications 
 
Study Population 
Inclusion Criteria: 
1. Age > 18 years 
2. Undergoing ERCP for biliary or pancreatic indications 
Exclusion Criteria: 
1. Vulnerable groups (e.g., pregnant women) 

2. Inability to provide informed consent 
3. Known cholangitis 
4. Known infection with CRE or other MDRO 
5. Surgically altered anatomy (except Billroth I) 
 
Study Interventions 
Participants will be randomized to undergo ERCP using one of the following duodenoscopes: 
• 
Group A: Duodenoscope with Disposable Distal End Cap (DDEC) 
• 
Group B: Conventional Reusable Duodenoscope (CRD) 
Both scopes are FDA-approved and considered standard of care. 
 
Outcome Measures 
The primary outcome measured in this study is the total patient complication rate, which includes cap 
detachment, severe mucosal injuries, post-ERCP pancreatitis, post-sphincterotomy bleeding, 
perforation, cholangitis, abdominal pain, fever, and procedure-related death. Secondary outcomes 
include the overall procedure success rate; successful intubation rates at key anatomical checkpoints 
(oropharyngeal/esophageal, gastroesophageal junction, and pyloric/duodenal regions); occurrence of 
suboptimal papillary positioning; total procedure time; cannulation time; fluoroscopy time and total 
radiation dose; use of advanced cannulation techniques; inadvertent duct cannulation; and need for 
crossover to an alternate duodenoscope due to technical failure or procedural difficulty.  
The initial sample size was determined based on an expected complication rate of 7% in the CRD group 
and 14% in the DDEC group. Assuming a 1:1 randomization, alpha error of 0.05, and study power of 80%, 
a total of 600 patients (300 per group) were required. Interim analyses were conducted during the study 
to assess efficacy and futility using conditional power analysis calculated with the frequentist Z-statistic 
method. 
• 
Maneuverability: Scored on a validated 5-point scale 
(1 = Easy; 5 = Unable to complete the required maneuver) 
• 
Mechanical Characteristics: 
Scope stiffness, air-water button functionality, elevator efficiency, and hand strain (each scored 
on a 5-point scale) 
• 
Imaging Characteristics: 
Image quality and image stability (each scored on a 5-point scale) 
 
Data Collection and Analysis 

• 
Data Collection: 
Conducted prospectively by evaluators during and after the procedure 
• 
Statistical Analysis: 
o 
Categorical variables compared using chi-square or Fisher’s exact tests, as appropriate 
o 
Analysis conducted using the intention-to-treat approach 
o 
Software: 
▪ 
IBM SPSS Statistics v29.0.2.0 (IBM Corp, Armonk, NY) 
▪ 
R v4.2.2 for conditional power analysis (R Foundation for Statistical Computing, 
Vienna, Austria) 
Ethical Considerations 
• 
IRB approval will be obtained prior to initiation 
• 
Written informed consent will be obtained from all participants 
• 
Data will be stored securely in compliance with HIPAA regulations 
• 
Adverse events will be monitored and reported in accordance with institutional guidelines 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Figure 1: Study flow diagram