Clinical trial · Interventional
Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy
Comparison of Multibending and Conventional Ultra-slim Upper Endoscope for the Direct Advance Into the Bile Duct Without Assisting Accessory in Peroral Cholangioscopy
- 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 aim of this study is to evaluate the usefulness of a newly developed multibending ultra-slim upper endoscope for the successful direct peroral cholangioscopy (POC) without assisting accessory in comparison with conventional ultra-slim endoscope. The investigators expect that multibending endoscope will show more higher successful performance than conventional endoscope.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bile Duct Diseases | — | UNRESOLVED | — |
| Biliary Stricture | — | UNRESOLVED | — |
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Common Bile Duct Calculi | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ultra-slim upper endoscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Direct peroral cholangioscopy
- description
- Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories
- interventionNames
- Device: ultra-slim upper endoscope
Primary outcomes (1)
- measure
- Technical success of the direct peroral cholangioscopy
- timeFrame
- 6 months
- description
- Successful insertion of a slim endoscope into the bile duct in no assisting accessories.
Secondary outcomes (1)
- measure
- Adverse events associated with direct POC
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Pancreatobiliary diseases that are indicated for direct POC * The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study * The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study * Dilated common bile duct (\> 8 mm) * Having previous sphincterotomy and/or papillary balloon dilation * The patients should not have any unacceptable conditions (e.g., physiological, familyish, social, geographical) for medical follow-up and adaptation of the study. Exclusion Criteria: * Contraindicated for ERCP * Patients with stricture on papillary orifice * Patients with periampullary malignancy * Bleeding tendency: International normalized ratio (INR) of prothrombin time \< 1.5 or platelet count \< 60,000/mm3 * Patients with other serious disease or medical condition * Patients with past medical history of significant neurologic or Psychiatric disorders such as dementia or seizure * Unstable heart disease despite of treatment, recent myocardial infarction within 6 month (Even though MI was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).
References
Publications (1)
- DERIVEDLee YN, Moon JH, Lee TH, Choi HJ, Itoi T, Beyna T, Neuhaus H. Prospective randomized trial of a new multibending versus conventional ultra-slim endoscope for peroral cholangioscopy without device or endoscope assistance (with video). Gastrointest Endosc. 2020 Jan;91(1):92-101. doi: 10.1016/j.gie.2019.08.007. Epub 2019 Aug 20. PMID 31442395