Background
Methods
Design and objectives
Study population
Inclusion criteria (must fulfill all) | |
1. Radiological diagnosis (with or without pathological confirmation) of borderline resectable, locally advanced, or unresectable malignant distal biliary obstruction at least 2 cm distal to the hilum (resectability based on tumor staging on axial imaging and physician evaluation) | |
2. Elevated liver tests with serum bilirubin at least three times above the upper limit of normal (1.2 mg/dl) Dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or US | |
3. Karnofsky index > 30% | |
4. ASA score < IV, and | |
5. Provision of informed consent | |
Exclusion criteria (any of the following) | |
1. Hilar obstruction | |
2. Uncorrectable coagulopathy and/or thrombocytopenia | |
3. Age < 18 | |
4. Liver metastasis > 30% of the liver volume | |
5. Liver cirrhosis with portal hypertension or ascites | |
6. Prior biliary sphincterotomy or stent placement | |
7. Surgically altered anatomy | |
8. Patient with clinical and radiological evidence of gastric outlet obstruction |
Patient identification and consent
Randomization
Treatment protocol
EUS-BD
ERCP
Endpoints
Meeting one or more of the following criteria: | |
□ Suspected cholangitis [13] | |
□ Definite cholangitis [13] | |
□ 50% increase in bilirubin from the lowest level post index procedure | |
□ 20% increase in bilirubin from the lowest level post index procedure AND evidence of obstruction on imaging (US/CT/MRI) | |
AND: | |
□ Endoscopic or radiological re-intervention confirming stent blockage or migration needing stent cleaning, stent change, and/or additional stent insertion |
2. Clinical success defined as 50% decrease in bilirubin < 2 weeks post-stent insertion or less than 25% of pre-procedure bilirubin level within 4 weeks post stent insertion [6] | |
3. Stent patency defined as mean time to stent obstruction or migration (patient will be censored at last-follow-up or death) | |
4. Proportion of patients with interruptions in chemotherapy treatment due to recurrent stent dysfunction | |
5. Early adverse events (within 14 days of index procedure) as defined per the ASGE lexicon for endoscopic adverse events [18], including post-procedural pancreatitis, bleeding, intestinal perforation, and cholangitis | |
6. Delayed adverse events (greater than 14 days of index procedure until last follow-up or death) | |
7. Cost-effectiveness analysis | |
Additional outcomes | |
1. Median number of days in delayed chemotherapy treatment if interrupted | |
2. Procedure time defined as from insertion of the endoscope to endoscope withdrawal1 | |
3. Fluoroscopy time | |
4. Rate of hospitalization and length of stay | |
5. Mortality |
Data collection
Follow-up
Statistical aspect
Sample size calculation
Analyses
Cost-effectiveness analysis
Trial management
Adverse event reporting
Definition of adverse event (AE)
Definition of Serious Adverse Event (SAE)
- Results in death
- Is immediately life-threatening
- Requires in-patient hospitalization or prolongation of existing hospitalization
- Results in persistent or significant disability or incapacity
- Is a congenital abnormality or birth defect
- Is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above
Coordinating Center
- Subject ID number, and initials
- Date of the event
- Description of the event
- Description of site’s response to the event
- Assessment of the subject’s condition
- Subject’s status on the study (on study, off study, etc.)