CompletedNot Applicable

Primary EUS-GBD in Patients With Unresectable Malignant Biliary Obstruction and Cystic Duct Orifice Involvement.

Ecuador22 participantsStarted 2018-07-01

Plain-language summary

to determine if primary prophylaxis with Endoscopic Ultrasound-Gallbladder Drainage (EUS-GBD) in unresectable cancer patients with the orifice of the cystic duct (OCD) involvement is superior to conservative management (Non EUS-guided gallbladder drainage).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Ocurrence of acute cholecystitis

Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Trial details

NCT IDNCT03729882

SponsorInstituto Ecuatoriano de Enfermedades Digestivas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-27

View on ClinicalTrials.gov More Acute Cholecystitis trials