Investigator initiated clinical trial to validate usefulness of specific system for endoscopic ultrasound guided hepaticogastrostomy (HG01) in malignant biliary obstructio

Not Applicable

• Conditions: Biliary obstruction due to unresectable malignant tumors; Malignant biliary obstruction, Endoscopic ultrasound, Biliary drainage, Hepatocogastrostomy; D001660

• Registration Number: JPRN-jRCT2052210020
• Lead Sponsor: Kitano Masayuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

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
(11) Poor general condition and estimated prognosis of less than 2 months
(12) Hemorrhagic diathesis including fetal aneurisms or severe coagulation disorder
(13) Participating in the other clinical trials (except non-intervention)
(14) Women who may possibly be pregnant or wants to be pregnant
(15) Metal allergy to nickel-titanium
(16) Know allergy to iodine contrast agents according to anaphylaxis guideline
(17) Patients whom the investigators decide inappropriate to participate in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified