Clinical trial NCT05905744: "eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis
Official title: A Prospective, Multicenter Clinical Study on the Diagnostic Value of "eyeMax Insight" Cholangioscopy for Unexplained Bile Duct Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bile Duct Stenosis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
name: Zhejiang University
name: The First Affiliated Hospital of Nanchang University
name: West China Hospital
name: LanZhou University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Peking University Cancer Hospital & Institute
name: First Hospital of China Medical University
name: First Affiliated Hospital of Guangxi Medical University
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: The Second Affiliated Hospital of Baotou Medical College
name: Shandong Province Third hospital
First posted: 2023-06-15
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with common bile duct stricture whose cause cannot be found by routine imaging and other examination methods.

Brief summary: 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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: positive rate of visual diagnosis of cholangioscopy for unexplained bile duct stenosis
timeFrame: 1 years
measure: positive rate of cholangioscopy-guided forceps biopsy
timeFrame: 1 years
Secondary outcomes:
measure: adverse event rate of each individual technique
timeFrame: 1 years
measure: the positive rate of biopsy
timeFrame: 1 years
Other outcomes:
Locations:
Study officials:
affiliation: Changhai Hospital
name: Yunfeng Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: