Biliary ObstructionNCT06287112
Prevention of Acute Cholecystitis With ETGBD
A study testing Endoscopic transpapillary gallbladder drainage (ETGBD) in people with Biliary Obstruction and Acute Cholecystitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Biliary Obstruction, Acute Cholecystitis
- What is being tested?
- Endoscopic transpapillary gallbladder drainage (ETGBD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2024to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Patients with acute cholecystitis, acute pancreatitis
- Patients who underwent cholecystectomy
- Patients with a life expectancy of less than 3 months
- Patients who are otherwise unable to undergo endoscopic retrograde cholangiopancreatography
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Woo Hyun Paik, MD, PhD, +82220722228, iatrus@snu.ac.kr
About this study
Official title: Efficacy of ETGBD Parallel Insertion With Fully Covered Self-expandable Metal Stent for Preventing Acute Cholecystitis in Patients With Low Cystic Duct Insertion
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.
- Conditions
- Biliary Obstruction, Acute Cholecystitis
- Being tested
- Endoscopic transpapillary gallbladder drainage (ETGBD)
- Keywords
- Malignant biliary obstruction, Fully covered self expandable metal stent, Endoscopic transpapillary gallbladder drainage, Preventive Effect, Acute cholecystitis
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic transpapillary gallbladder drainage (ETGBD)Device
Fully covered self-Expandable metal stent with Endoscopic transpapillary gallbladder drainage (ETGBD) in patient with cystic duct low insertion
| Study group | Role | What they receive |
|---|---|---|
| PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD) | Experimental | Not described Receives: Device: Endoscopic transpapillary gallbladder drainage (ETGBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of acute cholecystitis
Diagnosis of Acute cholecystitis will be based on the Tokyo Guidelines 2018
Measured: 2 months from the date of stent placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start20 Jun 2024
- Primary completion20 Feb 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary ObstructionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Hyun Paik, Seoul National University Hospital
- Investigators
- Woo Hyun Paik, MD., PhD., Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287112
- Sponsor's protocol ID
- PAC-ETGBD
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2024
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ETGBD Parallel Insertion With Fully Covered Self-expandable Metal Stent for Preventing Acute Cholecystitis in Patients With Low Cystic Duct Insertion
- ClinicalTrials.gov ID
- NCT06287112
- Acronym / sponsor ID
- PAC-ETGBD
- Conditions
- Biliary Obstruction, Acute Cholecystitis
- Keywords
- Malignant biliary obstruction, Fully covered self expandable metal stent, Endoscopic transpapillary gallbladder drainage, Preventive Effect, Acute cholecystitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD) | Experimental | Device: Endoscopic transpapillary gallbladder drainage (ETGBD) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
- Patients with acute cholecystitis, acute pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic transpapillary gallbladder drainage (ETGBD)Fully covered self-Expandable metal stent with Endoscopic transpapillary gallbladder drainage (ETGBD) in patient with cystic duct low insertion | Device | PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD) |
Primary outcome
Incidence rate of acute cholecystitis
Time frame: 2 months from the date of stent placement
Diagnosis of Acute cholecystitis will be based on the Tokyo Guidelines 2018
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Woo Hyun Paik, MD., PhD. study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic transpapillary gallbladder drainage (ETGBD) in people with Biliary Obstruction and Acute Cholecystitis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Myeong Hwan Lee, MD. (+82-10-7733-6494, dlaudghks01@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of acute cholecystitis (time frame: 2 months from the date of stent placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.