An Exploratory Study Investigating the Relationship of Bile, Gastric Juice, Duodenal Fluid, and Tissue Samples with Biliary Sludge Formation and Stent Occlusion in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound-Guided Hepaticogastrostomy (EUS-HGS)

An Exploratory Study Investigating the Relationship of Bile, Gastric Juice, Duodenal Fluid, and Tissue Samples with Biliary Sludge Formation and Stent Occlusion in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound-Guided Hepaticogastrostomy (EUS-HGS) - An Exploratory Study Investigating the Relationship of Bile, Gastric Juice, Duodenal Fluid, and Tissue Samples with Biliary Sludge Formation and Stent Occlusion in Patients Undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and Endoscopic Ultrasound-Guided Hepaticogastrostomy (EUS-HGS)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060161

Enrollment

150

Registered

2026-01-05

Start date

2025-12-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common bile duct stones, Benign biliary strictures, Malignant biliary strictures caused by pancreatic cancer or distal bile duct cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Patients aged 20 years or older. 2 Patients who undergo ERCP at our institution and meet at least one of the following criteria. 3 Patients who have been fully informed of the purpose and methods of this study and who have provided written informed consent.

Exclusion criteria

Exclusion criteria: 1 Patients presenting with severe (Grade III) acute cholangitis, as defined by the Tokyo Guidelines 2018. 2 Patients unable to provide written informed consent for participation in this study. 3 Patients who are deemed inappropriate for participation in this study at the discretion of the attending physician.

Design outcomes

Primary

Measure	Time frame
To evaluate the impact of bile components and the biliary microbiota, the duodenal fluid microbiota, and inflammatory and pathological changes in the bile duct and pancreas on biliary sludge formation and biliary stent patency.	—

Countries

Japan

Contacts

Public ContactYuya Hagiwara

Tsukuba Universiy Department of Gastroenterology

hagiwara.yuya.es@ms.hosp.tsukuba.ac.jp029-853-3900

Outcome results