A Single-center, Prospective Cohort Study on the Differentiation of Benign and Malignant Bile Duct Stenosis Based on Bile and Peripheral Blood cfDNA Methylation Profiles

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-10-30

Brief Summary

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The goal of this observational study is to detect the methylation characteristics of cfDNA in the bile and plasma of patients with bile duct stricture. The main question it aims to answer is: Can the developed model, using peripheral blood and bile cell-free DNA sequencing, work well in screening and classifying unknown biliary stricture? Participants will collect approximately 10ml of peripheral blood and 5ml of bile from the patient.

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Detailed Description

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Conditions

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Bile Duct Neoplasms Jaundice, Obstructive Bile Duct Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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malignant patients

The presence of biliary stricture due to malignant diseases, such as cholangiocarcinoma.

cfDNA methylation detection

Intervention Type DIAGNOSTIC_TEST

Extract cfDNA from bile and plasma, and perform methylation detection.

benign patients

The presence of biliary stricture due to benign diseases, such as inflammation.

cfDNA methylation detection

Intervention Type DIAGNOSTIC_TEST

Extract cfDNA from bile and plasma, and perform methylation detection.

Interventions

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cfDNA methylation detection

Extract cfDNA from bile and plasma, and perform methylation detection.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 1\. Patients with biliary stricture aged between 18 and 90 years old.
* 2\. Patients scheduled to undergo ERCP surgery due to obstructive jaundice or cholangitis.
* 3\. Definite benign or malignant diagnosis: with a pathological diagnosis of benign or malignant disease, or with follow-up data indicating a benign or malignant diagnosis.

Exclusion Criteria

* 1\. Receive radiotherapy, chemotherapy, or targeted therapy before sampling.
* 2\. Malignant tumors in other parts of the body (not related to biliary stricture).
* 3\. Unable to determine the nature of the biliary stricture.
* 4\. Ineligible for ERCP due to systemic conditions or gastrointestinal obstruction.
* 5\. Pregnant or breastfeeding women.
* 6\. Unable to sign the informed consent form.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes