"eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis

A Prospective, Multicenter Clinical Study on the Diagnostic Value of "eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis

When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. This study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ERCP.

Study Overview

• Status: Not yet recruiting
• Conditions: Bile Duct Stenosis
• Intervention / Treatment: Diagnostic test: cholangioscopy

Detailed Description

When clinical doctors cannot diagnose the cause of biliary stricture after comprehensive laboratory and imaging examinations, it is collectively referred to as unexplained bile duct stenosis. This study intends to analyze the diagnostic value of the biliary endoscopy system for unknown cause biliary strictures , and compare the diagnostic efficacy of biopsy under biliary endoscopy guidance with brushing cytology under ERCP.

The etiology of biliary strictures is complex, including not only malignant tumors , but also factors such as stones, inflammatory strictures, congenital variations and so on. Currently, the main methods for diagnosing malignant biliary obstruction in clinical practice include clinical examinations, biochemical testing (such as serum CA19-9), imaging, and endoscopic retrograde cholangiopancreatography (ERCP). However, these methods have limitations, such as the limited specificity and sensitivity of CA19-9 and the indirect imaging of ERCP after contrast agent filling. Therefore, these methods are relatively difficult to distinguish the benign and malignant nature of biliary lesions. This study intends to analyze the diagnostic value of the biliary endoscopy system for these unexplained bile duct stenosis.

• Study Type: Observational
• Enrollment (Estimated): 157

Contacts and Locations

• Study Contact: Name: Zhendong Jin, Doctor; Phone Number: 13901618837; Email: Zhendjin@126.com
• Study Contact Backup: Name: Yunfeng Wang, Doctor; Phone Number: 13651663501; Email: Fanhuiever@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with common bile duct stricture whose cause cannot be found by routine imaging and other examination methods.

Description

Inclusion Criteria:

Unexplained bile duct strictures (cannot be clearly diagnosed by CT, MRI or other imaging methods);

Exclusion Criteria:

• Patients with cardiac dysfunction, acute pancreatitis, active viral hepatitis;

  • Patients with mental illness; ③ Previously underwent choledochoscopy examination; ④ Malignant biliary obstruction;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with unexplained bile duct stenosis; Patients with unexplained bile duct stenosis undergo cholangioscopy examination and ERCP	Diagnostic test: cholangioscopy; cholangioscopy examination and forceps biopsy, followed by brush biopsy from ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
positive rate of visual diagnosis of cholangioscopy for unexplained bile duct stenosis	The results are compared with pathological results of surgical specimens	1 years
positive rate of cholangioscopy-guided forceps biopsy	The results are compared with pathological results of surgical specimens	1 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adverse event rate of each individual technique	record any adverse events related to the procedure	1 years
the positive rate of biopsy	cholangioscopy-guided forceps biopsy, ERCP-guided brush biopsy	1 years

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: The First Affiliated Hospital of Nanchang University; LanZhou University; West China Hospital; Peking University Cancer Hospital & Institute; First Affiliated Hospital Xi'an Jiaotong University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Zhejiang University; First Hospital of China Medical University; First Affiliated Hospital of Guangxi Medical University; Shandong Provincial Third Hospital; The Second Affiliated Hospital of Baotou Medical College; Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
• Investigators: Principal Investigator: Yunfeng Wang, Doctor, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Constriction, Pathologic; Cholestasis
• Other Study ID Numbers: eyeMAX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No