Patients with unresectable malignant biliary stricture planned for EUS-HGS malignant biliary stricture
Conditions
Interventions
Sponsors
Kitano Masayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients aged 20 years or older at the time of consent. (2) Patients who have been pathologically diagnosed with malignancy or are strongly suspected of having malignancy based on imaging studies. (3) Patients scheduled to undergo EUS-guided hepaticogastrostomy (EUS-HGS) for unresectable malignant biliary stricture. (4) Patients expected to survive for more than 3 months after treatment. (5) Patients who undergo EUS-HGS as the initial drainage treatment or as a secondary drainage treatment following failure of the initial procedure. (6) Patients who have provided written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients judged to be unsuitable for endoscopic treatment. (2) Patients with a history of left hepatic lobectomy. (3) Patients who have undergone total gastrectomy. (4) Patients diagnosed with perihilar cholangiocarcinoma classified as Bismuth type 3b or 4. (5) Patients with an ECOG Performance Status of 4. (6) Patients with uncontrolled ascites. (7) Patients with severe comorbidities (cardiac, pulmonary, renal, or hepatic diseases), generally corresponding to ASA Physical Status > 4 or higher. (8) Patients with bleeding tendency (defined as PT-INR >1.5 or platelet count < 50,000/uL) (9) Patients with PTBD tubes in place at the time of consent (10) Patients deemed inappropriate for inclusion by the principal or sub-investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recurrent biliary obstruction (TRBO) until 180 days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Technical success rate (2) Clinical success rate (3) The cumulative incidence of RBO during the overall survival (4) Time to RBO during the overall survival (5) Adverse event rate (6) Procedure time (7) Re-intervention success rate (8) Overall survival (OS) (9) Rate of chemotherapy administration after biliary drainage (10) Total medical costs related to treatment for biliary obstruction | — |
Contacts
Public ContactMasahiro Itonaga
Wakayama Medical University Hospital
Outcome results
None listed