Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05429203

Enrollment

319

Registered

2022-06-23

Start date

2022-10-25

Completion date

2024-07-29

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Disease, Biliary Obstruction, Biliary Tract Neoplasms, Choledocholithiasis, Pancreatic Disease, Pancreatic Neoplasms

Keywords

ERCP, Duodenoscope, Duodenoscope with single-use distal cover

Brief summary

The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.

Detailed description

The risks associated with the ERCP procedure will be explained to patients who meets the eligibility criteria. Consenting patients will be randomized to undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either (1) a duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope. Assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.

Interventions

DEVICEDuodenoscope with single-use distal cover

Newer duodenoscope with a single-use distal cover

DEVICEConventional duodenoscope

Conventional duodenoscope with standard methods of reprocessing

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients undergoing ERCP for biliary and pancreatic conditions * Age \> 18 years old

Exclusion criteria

* Vulnerable patient groups including pregnant women * Patients who are unable to consent * Patients with known cholangitis * Patients with known Carbapenem-Resistant Enterobacteriaceae (CRE) or any other multi-drug resistant organisms (MDRO) infection * Surgically altered anatomy except for Billroth I

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Procedure-related Adverse Events	3 months	Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes were assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.

Secondary

Measure	Time frame	Description
Duodenoscope Maneuverability: Passage Into Stomach	Maneuverability will be assessed only during the procedure (approximately 10 minutes)	Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Duodenoscope Maneuverability: Navigation Across Pylorus	Maneuverability will be assessed only during the procedure (approximately 10 minutes)	Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Duodenoscope Maneuverability: Achieving Short Position of the Scope	Maneuverability will be assessed only during the procedure (approximately 10 minutes)	Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Duodenoscope Maneuverability: Achieving Optimal Papillary Position	Maneuverability will be assessed only during the procedure (approximately 10 minutes)	Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Duodenoscope Mechanical Characteristics Profile: Scope Stiffness	Mechanical characteristics assessed only during the procedure (approximately 15 minutes)	Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Duodenoscope Maneuverability: Intubation Into Esophagus	Maneuverability will be assessed only during the procedure (approximately 10 minutes)	Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency	Mechanical characteristics assessed only during the procedure (approximately 15 minutes)	Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.
Duodenoscope Mechanical Characteristics Profile: Hand Strain	Mechanical characteristics assessed only during the procedure (approximately 15 minutes)	Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being no strain, 2 minimal strain, 3 moderate strain, 4 severe strain and 5 unable to complete the procedure.
Duodenoscope Imaging Characteristics Profile: Image Quality	Imaging characteristics were assessed only during the procedure (approximately 15 minutes)	Providers assessed the 2 duodenoscopes for their imaging characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being superior, 2 good, 3 satisfactory, 4 suboptimal and 5 unable to visualize or achieve stability of image resulting in termination of procedure.
Duodenoscope Imaging Characteristics Profile: Image Stability	Imaging characteristics were assessed only during the procedure (approximately 15 minutes)	Providers assessed the 2 duodenoscopes for their imaging characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being superior, 2 good, 3 satisfactory, 4 suboptimal and 5 unable to visualize or achieve stability of image resulting in termination of procedure.
Number of Participant With Procure Success (Ability to Perform Interventions)	30-60 minutes	Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their ability to perform endoscopic maneuvers like sphincterotomy, balloon sweep, use of basket/mechanical lithotriptor, stone clearance, stricture dilation using balloon/catheter, stent insertion, stent removal and use of single operator cholangioscopy/pancreatoscopy.
Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality	Mechanical characteristics assessed only during the procedure (approximately 15 minutes)	Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being no water leakage or no difficulty in applying suction or inflating air, 2 minimal leakage or minimal difficulty with suction or inflation, 3 moderate leakage or difficulty, 4 severe leakage or difficulty and 5 unable to perform the requisite function.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Duodenoscope With Disposable Distal End Caps Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	159
Conventional Reusable Duodenoscope Patients will undergo ERCP using a conventional duodenoscope.	160
Total	319

Baseline characteristics

Characteristic	Conventional Reusable Duodenoscope	Total	Duodenoscope With Disposable Distal End Caps
Age, Continuous	65 years	65 years	64.5 years
Previous ERCP Index	44 Participants	89 Participants	45 Participants
Previous ERCP Repeat	116 Participants	230 Participants	114 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	48 Participants	89 Participants	41 Participants
Race (NIH/OMB) Black or African American	33 Participants	60 Participants	27 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants	33 Participants	16 Participants
Race (NIH/OMB) White	62 Participants	137 Participants	75 Participants
Region of Enrollment United States	160 Participants	319 Participants	159 Participants
Sex: Female, Male Female	74 Participants	130 Participants	56 Participants
Sex: Female, Male Male	86 Participants	189 Participants	103 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 159	0 / 160
other Total, other adverse events	8 / 159	8 / 160
serious Total, serious adverse events	8 / 159	9 / 160

Outcome results

Primary

Number of Participants With Procedure-related Adverse Events

Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes were assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.

Time frame: 3 months

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Duodenoscope With Disposable Distal End Caps	Number of Participants With Procedure-related Adverse Events	8 Participants
Conventional Reusable Duodenoscope	Number of Participants With Procedure-related Adverse Events	9 Participants

p-value: 0.8Chi-squared

Secondary

Duodenoscope Imaging Characteristics Profile: Image Quality

Providers assessed the 2 duodenoscopes for their imaging characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being superior, 2 good, 3 satisfactory, 4 suboptimal and 5 unable to visualize or achieve stability of image resulting in termination of procedure.

Time frame: Imaging characteristics were assessed only during the procedure (approximately 15 minutes)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Duodenoscope With Disposable Distal End Caps	Duodenoscope Imaging Characteristics Profile: Image Quality	Rating = 1	154 Participants
Duodenoscope With Disposable Distal End Caps	Duodenoscope Imaging Characteristics Profile: Image Quality	Rating = 3	1 Participants
Duodenoscope With Disposable Distal End Caps	Duodenoscope Imaging Characteristics Profile: Image Quality	Rating = 5	0 Participants
Duodenoscope With Disposable Distal End Caps	Duodenoscope Imaging Characteristics Profile: Image Quality	Rating = 4	0 Participants
Duodenoscope With Disposable Distal End Caps	Duodenoscope Imaging Characteristics Profile: Image Quality	Rating = 2	4 Participants
Conventional Reusable Duodenoscope	Duodenoscope Imaging Characteristics Profile: Image Quality	Rating = 5	0 Participants
Conventional Reusable Duodenoscope	Duodenoscope Imaging Characteristics Profile: Image Quality	Rating = 1	154 Participants
Conventional Reusable Duodenoscope	Duodenoscope Imaging Characteristics Profile: Image Quality	Rating = 2	4 Participants
Conventional Reusable Duodenoscope	Duodenoscope Imaging Characteristics Profile: Image Quality	Rating = 3	2 Participants
Conventional Reusable Duodenoscope	Duodenoscope Imaging Characteristics Profile: Image Quality	Rating = 4	0 Participants

p-value: 0.8Fisher Exact

Secondary

Duodenoscope Imaging Characteristics Profile: Image Stability

Time frame: Imaging characteristics were assessed only during the procedure (approximately 15 minutes)

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Duodenoscope With Disposable Distal End Caps	Duodenoscope Imaging Characteristics Profile: Image Stability	Rating = 2	3 Participants
Duodenoscope With Disposable Distal End Caps	Duodenoscope Imaging Characteristics Profile: Image Stability	Rating = 4	0 Participants
Duodenoscope With Disposable Distal End Caps	Duodenoscope Imaging Characteristics Profile: Image Stability	Rating = 3	0 Participants
Duodenoscope With Disposable Distal End Caps	Duodenoscope Imaging Characteristics Profile: Image Stability	Rating = 5	0 Participants
Duodenoscope With Disposable Distal End Caps	Duodenoscope Imaging Characteristics Profile: Image Stability	Rating = 1	156 Participants
Conventional Reusable Duodenoscope	Duodenoscope Imaging Characteristics Profile: Image Stability	Rating = 5	0 Participants
Conventional Reusable Duodenoscope	Duodenoscope Imaging Characteristics Profile: Image Stability	Rating = 1	157 Participants
Conventional Reusable Duodenoscope	Duodenoscope Imaging Characteristics Profile: Image Stability	Rating = 2	3 Participants
Conventional Reusable Duodenoscope	Duodenoscope Imaging Characteristics Profile: Image Stability	Rating = 3	0 Participants
Conventional Reusable Duodenoscope	Duodenoscope Imaging Characteristics Profile: Image Stability	Rating = 4	0 Participants

p-value: 0.9Fisher Exact

Secondary

Duodenoscope Maneuverability: Achieving Optimal Papillary Position

Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.