Prevention of Acute Cholecystitis With ETGBD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital
About this trial
The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.
In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults 19 years of age or older
Patients requiring endoscopic retrograde cholangiography and drainage for therapeutic purposes.
Patients with imaging (CT, Cholangiogram) confirmed confluence of the cystic duct with the distal third of the common bile duct.
Patients who have voluntary informed consent to participate in the study.
Disqualifiers
Patients who have undergone percutaneous/surgical bile duct or gallbladder drainage prior to study enrollment.
Patients with anatomic deformity of the upper gastrointestinal tract after gastric or hepatobiliary surgery
Patients with concomitant gastric/duodenal obstruction
Patients with confirmed or suspected cystic duct obstruction on imaging studies
Trial design
Design model
Single group
Treatments tested in this trial
Endoscopic transpapillary gallbladder drainage (ETGBD)
DeviceFully covered self-Expandable metal stent with Endoscopic transpapillary gallbladder drainage (ETGBD) in patient with cystic duct low insertion
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence rate of acute cholecystitis
Diagnosis of Acute cholecystitis will be based on the Tokyo Guidelines 2018
Time frame
2 months from the date of stent placementSponsors and contacts
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Source ClinicalTrials.gov