Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.
Acute Cholecystitis
About this trial
This is an interventional prevention trial for Acute Cholecystitis focused on measuring endoscopic ultrasound, acute cholecystitis, cholangiocarcinoma, gallbladder drainage, metallic stents
Eligibility Criteria
Inclusion Criteria:
- Above 18 years old.
- Obtained written consent for procedures
- Unresectable malignant biliary obstruction diagnosed by Endoscopic Ultrasound and confirmed by confocal laser endomicroscopy (CLE) during cholangioscopy and histopathology.
- Tumor involvement to the orifice of the cystic duct.
- Self-expandable metallic plastic stent deployment as palliative therapy for distal biliary obstruction.
Exclusion Criteria:
- Under 18 years old.
- Refuse to sign written informed consent.
- Pregnancy
- Previous cholecystectomy
- Acute cholecystitis prior enrollment
- Severe ascites that increases the distance between gastric or duodenal and gallbladder walls.
- Large vessel between the gallbladder and gastric-duodenal wall.
- Coagulopathy
- Intrahepatic cholangiocarcinoma
- Previous gallbladder drainage by percutaneous or endoscopic techniques.
Sites / Locations
- Instituto Ecuatoriano de Enfermedades Digestivas
Arms of the Study
Arm 1
Arm 2
Other
Other
EUS-guided gallbladder drainage
Non EUS-guided gallbladder drainage
In one arm, Endoscopic Ultrasound-Gallbladder Drainage (EUS-GBD) will be performed by using a 3,8 mm therapeutic echoendoscope and a lumen apposing metal stent ( Hot AXIOS™ Stent and Electrocautery Enhanced Delivered System; Boston Scientific Corporation, Natick, MA, USA) after conventional biliary drainage with self-expandable metallic stents during endoscopic retrograde cholangiopancreatography (ERCP). All procedures will be performed under general anesthesia.
In the other arm, patients will undergo conventional biliary drainage with self-expandable metallic stent placement during ERCP evaluation without prophylactic EUS-GBD and will be considered as a Non EUS-guided gallbladder drainage. All procedures will be performed under general anesthesia.