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Combination of ERCP plus EUS-guided hepaticogastrostomy versus PTBD for biliary drainage in malignant hilar biliary obstruction: a prospective controlled trial

Phase 3
Completed
Conditions
Malignant Hilar Obstruction secondary to Cholangiocarcinoma
Malignant hilar biliary obstruction&#44
Hilar Cholangiocarcinoma&#44
Klatskin&#39
s Tumor&#44
Perihilar Cholangiocarcinoma&#44
Endosonography&#44
Endoscopic Ultrasonography&#44
ERCP&#44
EUS&#44
Registration Number
TCTR20180711004
Lead Sponsor
King Chulalongkorn Memorial Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
19
Inclusion Criteria

a. Patients aged 18-85
b. Jaundiced patients with bile duct obstruction due to cholangiocarcinoma
c. Clinical symptoms and findings that suggest that cholangiocarcinoma is the cause of
obstruction
d. Results of evaluation showing that they were not cured by surgery (unresectable
tumors)
e. Patients consented to endoscopic drainage

Exclusion Criteria

a. Pregnant patients
b. Patients with contraindication to endoscopy

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rate of recurrent biliary obstruction of the CERES procedure 3 months Number of subjects with recurrent biliary obstruction at month 3
Secondary Outcome Measures
NameTimeMethod
Time to biliary reinterventions about 3-12 months Duration from successful CERES procedure to biliary reintervention procedure
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