JPRN-jRCT2052210020
Completed
未知
Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstruction - HG01
Kitano Masayuki0 sites40 target enrollmentMay 10, 2021
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Biliary obstruction due to unresectable malignant tumors
- Sponsor
- Kitano Masayuki
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Ages of more than 20 years old when obtaining informed consent
- •(2\) Malignancy of pathological diagnosis
- •(3\) Biliary obstruction due to unresectable malignant tumors
- •(4\) Failured, impossible or difficult in biliary drainage with ERCP
- •(5\) Serum bilirubin level of higher than 3\.0 mg/dl before enrollment
- •(6\) Obtaining the document for informed consent from the patient
Exclusion Criteria
- •(1\) Impossible to perform endoscopy
- •(2\) After total gastrectomy
- •(3\) After left hepatectomy
- •(4\) Bismuth classification for hilar biliary carcinoma : Type IIIb or Type IV
- •(5\) Liver cirrhosis
- •(6\) Ascites around the liver on CT
- •(7\) With PTBD tube at obtaining informed consent
- •(8\) Planned insertion of metal stent in the upper gastrointestinal tract within 7 days before treatment
- •(9\) Performance status 4
- •(10\) Severe other diseases in the heart, lund, kidney and/or liver. ASA 4 or higher
Outcomes
Primary Outcomes
Not specified
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