Acute cholecystitis Acute cholecystitis
Conditions
Interventions
The mechanism of acute cholecystitis following FCSEMS placement is considered to be obstruction of the cystic duct orifice by the stent. This study will evaluate whether attempting EGBS at the time of
EGBS
Sponsors
Oda Takayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years or older at the time of registration. 2. Patients diagnosed with malignant distal biliary obstruction due to pancreatic cancer, distal bile duct cancer, ampullary cancer, or other malignant tumors such as lymph node metastasis, resulting in obstructive jaundice. 3. Patients without a history of cholecystectomy. 4. Patients expected to have a prognosis of at least 4 months. 5. Patients who have provided written informed consent for participation in this study, either by themselves or through a legal representative.
Exclusion criteria
Exclusion criteria: 1. Patients who have already undergone gallbladder drainage by PTGBD, EUS-GBD, or EGBS at the time of registration. 2. Patients with surgically reconstructed intestines other than Billroth I reconstruction. 3. Patients in whom imaging studies such as CT or MRI indicate, in the judgment of the physician, that FCSEMS placement will not occlude the cystic duct orifice. 4. Patients in whom ERCP is considered difficult due to gastrointestinal obstruction caused by duodenal invasion of the tumor. 5. Patients with upper gastrointestinal perforation, for whom ERCP is contraindicated. 6. Patients who are pregnant, may be pregnant, or wish to become pregnant during the study period. 7. Patients expected to have difficulty attending an in-person follow-up visit by the attending physician 30 days after FCSEMS placement. 8. Patients participating in another clinical trial or investigational study of a drug or medical device concurrently with this trial, or within 30 days prior to enrollment. 9. Patients deemed otherwise inappropriate for inclusion in this study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of cholecystitis within 30 days after FCSEMS placement in all cases in which EGBS was attempted | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Success rate of EGBS 2. Incidence of adverse events related to EGBS 3. Incidence of cholecystitis after SEMS placement in cases with successful EGBS 4. Incidence of cholecystitis occurring after 31 days following FCSEMS placement | — |
Contacts
Public ContactTakayuki Oda
Yokohama City University Hospital
Outcome results
None listed