Biliary Drainage in Patients With Duodenal Metal Stent

Tokyo University

Status: Unknown

Conditions: Jaundice

Treatments: Procedure: Biliary drainage

Study type: Observational

Funder types: Other

Identifiers

NCT02376907

10639

Details and patient eligibility

About

This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric outlet obstruction (GOO) and the location of GOO.

Full description

This is a multinational multicenter retrospective cohort study to evaluate the outcomes of endoscopic biliary drainage in patients with a duodenal SEMS. Endoscopic ultrasound-guided biliary drainage (EUS-BD), including choledochoduodenostomy, hepaticogastrostomy, antegrade biliary stenting or a combination, and endoscopic retrograde cholangiopancreatography (ERCP) with stenting are to be compared. Specifically, the outcomes are to be evaluated according to the timing of distal MBO in relation to GOO and the location of GOO.

Enrollment: 200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who underwent endoscopic placement of a duodenal SEMS for nonresectable malignant GOO.
• Patients who underwent endoscopic biliary drainage for nonresectable MBO.
• MBO was located ≥ 2 cm from the bifurcation.
• Patients who could be followed up more than three months after completion of both biliary drainage and duodenal SEMS placement.
• Age ≥20 years.
• Irrespective of sex and a primary disease.

Exclusion criteria

• Patients who underwent surgical bypass for GOO.
• Patients who underwent percutaneous and surgical biliary drainage prior to the placement of duodenal SEMS.
• Patients with altered gastrointestinal anatomy (Billroth-II reconstruction, Roux-en-Y reconstruction, etc.).
• Patients who would not give a consent to the report of their own data.
• Patients considered ineligible for inclusion in the study by an investigator for other reasons.

Trial design

200 participants in 1 patient group

EUS-BD or ERCP with duodenal SEMS

Description:

Patients who underwent endoscopic placement of a duodenal self-expandable metal stent (SEMS) for nonresectable malignant GOO and endoscopic biliary drainage for nonresectable distal MBO.

Treatment:

Procedure: Biliary drainage