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

JRCT ID: jRCT2052210020

Registered date:10/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Biliary obstruction due to unresectable malignant tumors
• Date of first enrollment: 14/05/2021
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Endoscopic ultrasound guided hepaticogastrostomy

Outcome(s)

• Primary Outcome: Clinical success rate

Secondary Outcome

- Technical success rate
- Adverse events rate
- Procedure time
- Technical success rate using this device alone
- Stent patency 30 and 60 days after treatment
- Technical success rate of re-intervention after stent dysfunction and the method for re-intervention
- Patient survival 60 days after treatment
- Stent migration 1, 14, 30 and 60 days after treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kitano Masayuki
• Source(s) of Monetary Support: ZEON CORPORATION