Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Disease | — | UNRESOLVED | — |
| Biliary Obstruction | — | UNRESOLVED | — |
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
| Choledocholithiasis | — | UNRESOLVED | — |
| Pancreatic Disease | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional duodenoscope | Device | — | UNRESOLVED |
| Duodenoscope with single-use distal cover | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Duodenoscope with single-use distal cover
- description
- Patients will undergo ERCP using a duodenoscope with a single-use distal cover
- interventionNames
- Device: Duodenoscope with single-use distal cover
- type
- ACTIVE_COMPARATOR
- label
- Conventional Duodenoscope
- description
- Patients will undergo ERCP using a conventional duodenoscope
- interventionNames
- Device: Conventional duodenoscope
Primary outcomes (1)
- measure
- Number of Participants With Procedure-related Adverse Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDBang JY, Rosch T, Kim HM, Thakkar S, Robalino Gonzaga E, Tharian B, Inamdar S, Lee LS, Yachimski P, Jamidar P, Muniraj T, DiMaio C, Kumta N, Sethi A, Draganov P, Yang D, Seoud T, Perisetti A, Bondi G, Kirtane S, Hawes R, Wilcox CM, Kozarek R, Reddy DN, Varadarajulu S. Prospective evaluation of an assessment tool for technical performance of duodenoscopes. Dig Endosc. 2021 Jul;33(5):822-828. doi: 10.1111/den.13856. Epub 2020 Nov 17. PMID 33007136