Unresectable malignant distal biliary obstruction
Conditions
Interventions
Endoscopic ultrasound hepatogastric anastomosis plus progressive bile duct stenting (EUS-HGAS) or endoscopic ultrasound hepatogastric stenting (EUS-HGS) for malignant biliary stricture that is difficu
Sponsors
Ishiwatari Hirotoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with malignant biliary strictures located at least 2 cm distal to the hepatic hilum. 2.Malignant biliary stricture diagnosed based on pathological findings or imaging studies. 3.Unresectability confirmed by imaging studies or patient-related factors (e.g., comorbidities, age). 4.Patients with jaundice or abnormal liver function. Jaundice is defined as a serum total bilirubin level of >-2.0 mg/dL. Abnormal liver function is defined as at least two of the following parameters (AST, ALT, ALP, y-GTP) exceeding twice the upper limit of the institution' s reference range. 5.Performance status (PS) of 0-2 according to the ECOG criteria. 6.Age of >-18 years at the time of informed consent. 7.Patients meeting either (i) or (ii): (i) ERCP-BD was attempted but failed to achieve deep biliary cannulation or traversal of the biliary stricture, or ERCP-BD was deemed difficult due to conditions such as duodenal stenosis or post-surgical altered anatomy. (ii) Imaging studies prior to ERCP-BD indicated that the procedure would likely be technically challenging. 8.Life expectancy estimated to be >-3 months. 9.Written informed consent obtained from the patient.
Exclusion criteria
Exclusion criteria: 1.A bile duct stent is in place. 2.Presence of a hilar biliary stricture classified as Bismuth type II or higher. 3.Maximum diameter of both B2 and B3 branches less than 1 mm. 4.History of biliary-enteric anastomosis (hepaticojejunostomy). 5.Gastrointestinal obstruction distal to the horizontal portion of the duodenum or placement of a gastrointestinal stent in this region. 6.Severe dysfunction of other organs, such as liver failure, renal failure, or heart failure. 7.Patients with a bleeding tendency defined as a platelet count -1.5 (patients may be eligible if these conditions improve with supportive care, such as transfusion or vitamin K administration). 8.Patients in whom antithrombotic therapy cannot be discontinued as per the guidelines of the Japan Gastroenterological Endoscopy Society. 9.Presence of massive ascites. 10.Patients with an allergy to nickel, titanium, or gold. 11.Any other conditions deemed unsuitable for participation in the study by the principal investigator or sub-investigator for ensuring the safety of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TRBO (time to RBO_ time to stent occlusion) | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Percentage of procedural success (2) Clinical success rate (3) Incidence of adverse events associated with stent placement (early and late) (4) Procedure time (5) Radiation time during the procedure (6) Non-RBO rate (3, 6 and 12 months) (7) Causes of RBO (8) Cost of treatment (total cost including initial treatment and readmission to hospital) (9) Duration of survival (10) Passage of the biliary stricture with the test stent during EUS-HGAS | — |
Contacts
Public ContactHiroki Sakamoto
Shizuoka Cancer Center
Outcome results
None listed