Jaundice
Conditions
Keywords
distal malignant biliary obstruction, endoscopic retrograde cholangiopancreatography, endoscopic ultrasound, gastric outlet obstruction, stent
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREBiliary drainage
EUS-BD or ERCP
Sponsors
Tokyo University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recurrent biliary obstruction | Up to 1 year | Recurrent biliary obstruction is defined as a composite endpoint of either occlusion or migration of biliary stent, and time to recurrent biliary obstruction is time from biliary drainage to recurrence of biliary obstruction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Causes of recurrent biliary obstruction | Up to 1 year | Causes of recurrent biliary obstruction include sludge, food impaction, ingrowth, tumor overgrowth, hemobilia and others. |
| Functional success rate of biliary drainage | 2 weeks | Functional success is defined when bilirubin decreases \< 50% or is normalized within 2 weeks. |
| Procedure-related complication of biliary drainage and duodenal meta stent placement (type and severity) | 30 days | Complications and their severity are determined using the American Society of Gastrointestinal Endoscopy guidelines. |
| Survival time | Up to 2 year | Survival time is defined as the period between biliary stent placement and death. |
Countries
China, Hong Kong, India, Japan, Malaysia, Singapore, South Korea, Taiwan, Thailand
Outcome results
None listed