Clinical trial NCT02189421: Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy
Official title: Comparison of Multibending and Conventional Ultra-slim Upper Endoscope for the Direct Advance Into the Bile Duct Without Assisting Accessory in Peroral Cholangioscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Common Bile Duct Calculi
Biliary Tract Cancer
Biliary Stricture
Bile Duct Diseases
Keywords: peroral cholangioscopy
ultra-slim upper endoscope
multibending endoscope
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: Direct POC using an ultra-slim upper endoscope permits various diagnostic and/or therapeutic intraductal interventions under direct endoscopic visualization in selected patients who has dilated distal CBD and widened papillary orifice. Because the bile duct has anatomical position in acute angle with the duodenum, assisting accessories such as intraductal anchoring balloon, guidewire or overtube is usually required for the successful direct POC. Recently, direct peroral cholangioscopes have been developed for free-hand direct advancement of the endoscope into the bile duct from duodenum. Multibending ultra-slim endoscope may be expected to facilitate the advance into the bile duct by overcoming the acute angle between the bile duct and the duodenum. After randomization of enrolled patients into two groups, direct POC will be performed by using a conventional slim endoscope in control group and by using a multibending endoscope in study group.

Eligibility criteria: 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).

Primary outcomes:
measure: Technical success of the direct peroral cholangioscopy
timeFrame: 6 months
Secondary outcomes:
measure: Adverse events associated with direct POC
timeFrame: 6 months
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
Study officials:
affiliation: SoonChunHyang University School of Medicine
name: Jong Ho Moon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee 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.