Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy

Biliary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02189421
• Other study ID #: SCHBC 2014-06-012-001
• Status: Active, not recruiting
• Phase: N/A
• First received: July 9, 2014
• Last updated: October 30, 2015
• Start date: April 2014
• Est. completion date: February 2016

Study information

• Verified date: October 2015
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: February 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Bile Duct Diseases
• Biliary Stricture
• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Common Bile Duct Calculi

Intervention

Device:
• ultra-slim upper endoscope
Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success of the direct peroral cholangioscopy	Successful insertion of a slim endoscope into the bile duct in no assisting accessories.	6 months	Yes
Secondary	Adverse events associated with direct POC	Cholangitis: fever and abdominal pain with abnormal liver function test; Hemobilia: bleeding from the bile duct; Pancreatitis: abdominal pain with elevation of the serum amylase and lipase; Bile duct perforation: any evidence of bile duct perforation in imaging studies.; Air embolism: clinical and imagine findings with air embolism	6 months	Yes