Gastric outlet obstruction and biliary obstruction
Conditions
Interventions
Endoscopic duodenal stenting + EUS-HGS
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with biliary stricture(MBO)and duodenal stricture(GOO)due to unresectable malignancy. 2) Diagnosis of pancreatic cancer or cholangiocarcinoma by diagnostic imaging or cytological/histological diagnosis. 3) Patients must meet one of the following criteria, or in blood tests. 4) T-Bil >1.5mg/dL, 2) AST >100U/L, 3) ALT >100U/L 5) Duodenal stent is not implanted. 6) GOOSS is 0 or 1 point. 7) The location of the duodenal stricture is type.1 or type.2. 8) MBO precedes and the need for treatment of GOO arises later, and the biliary tract is reoccluded at the time of the appearance of GOO, and the need for treatment of MBO and GOO arises simultaneously. 9) When MBO and the need for treatment of GOO occur simultaneously. 10) The patient does not have Bismuth II or higher hilar bile duct stenosis. 11) There is no gastrointestinal obstruction in the small or large intestine anterior to the duodenum. 12) The patient is expected to improve with biliary drainage. 13) The patient does not have ascites of more than moderate degree. 14) P.S. (ECOG): 0, 1, 2 15) Age: 20 years or older 16) Written consent for participation in the study has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1) The physician judges that enrollment in this study is inappropriate. 2) The patient has moderate or severe acute cholangitis (diagnostic criteria and severity are in accordance with Tokyo Guidelines 2018).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Percentage of successful clinical reduction 2) Percentage of improvement in GOO scoring system 3) Percentage of adverse events 4) Percentage of procedural success 5) Stent patency period 6) Stent survival patency period 7) Re-intervention success rate 8) Incidence of adverse events related to Re-intervention | — |
Countries
Japan
Contacts
Public ContactHidetoshi Kitamura
National Cancer Center Hospital Department of Hepatobiliary and Pancreatic Oncology Division
Outcome results
None listed