Acute CholecystitisEGDBNCT04197908
EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.
A study testing EUS-guided gallbladder drainage (EGBD) in people with Acute Cholecystitis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- EUS-guided gallbladder drainage (EGBD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2019to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous cholecystitis indicated for laparoscopic cholecystectomy would be included.
Who cannot join
- Pregnancy
- Patients unwilling to undergo follow-up assessments
- Patients with suspected gangrene or perforation of the gallbladder
- Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
- Patients with duodenal obstruction
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
Show all 9Show fewer
- Patients with liver cirrhosis, portal hypertension and/or gastric varices
- Abnormal coagulation: international normalised ratio (INR) > 1.5 and/or platelets < 50.000/mm3
- Previous drainage of the gallbladder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Ultrasound (EUS)-Guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis: A Feasibility Study
To evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy.
Read the detailed description
The gold standard for treatment of acute calculous cholecystitis is laparoscopic cholecystectomy. Recently, gallbladder drainage with EUS-guided gallbladder drainage (EGBD) has been described as a treatment option. However, whether this is an effective treatment option in surgically fit patients are uncertain.
The aim of the current study is to evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy. The investigators hypothesis that the technique is safe and feasible.
- Conditions
- Acute Cholecystitis
- Being tested
- EUS-guided gallbladder drainage (EGBD)
- Keywords
- Acute cholecystitis, EUS-guided gallbladder drainage, Laparoscopic cholecystectomy, gallbladder polyp, gallstone
- Medical subject headings
- Cholecystitis, Acute, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided gallbladder drainage (EGBD)Device
As listed in the arms description
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided gallbladder drainage (EGBD) | Experimental | The procedure would be performed with a linear echoendoscope using a 10mm x 10mm or a 15 x 10mm stent. The distal flange of the stent would be deployed under EUS guidance, followed by deployment of the proximal flange under endoscopic guidance. Once deployed, the gallbladder would be completely emptied by suction and irrigation until the effluent through the stent is clean. Receives: Device: EUS-guided gallbladder drainage (EGBD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate
Complete resolution of acute cholecystitis as defined by resolution of fever, pain and change of white cell counts of 10%
Measured: 30 days
Secondary outcomes (6)
Technical success rate
Defined as successful placement of a metal stent between the gallbladder and the duodenum or the stomach
Measured: 30 days
30-day adverse events rate
Adverse events would be graded according to the lexicon of endoscopic adverse events
Measured: 30 days
Stone or polyp recurrences
An ultrasonography of the abdomen would also be arranged yearly to check for recurrence of stones or polyps.
Measured: 3 years
Quality of life scores: Gastrointestinal quality of life index
Gastrointestinal quality of life index
Measured: 3 years
Mortality rate
Death from any cause
Measured: 3 years
Reintervention rate
The number of patients requiring biliary related re-interventions within 3 years.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start29 Nov 2019
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Teoh, Chinese University of Hong Kong
- Investigators
- Anthony Teoh, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197908
- Sponsor's protocol ID
- CREC-2016.609
- Acronym
- EGDB
- Status last verified
- Mar 2026
- First submitted
- 6 Dec 2019
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound (EUS)-Guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04197908
- Acronym / sponsor ID
- EGDB / CREC-2016.609
- Conditions
- Acute Cholecystitis
- Keywords
- Acute cholecystitis, EUS-guided gallbladder drainage, Laparoscopic cholecystectomy, gallbladder polyp, gallstone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Dec 2019 (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.
To evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy.
Detailed description
The gold standard for treatment of acute calculous cholecystitis is laparoscopic cholecystectomy. Recently, gallbladder drainage with EUS-guided gallbladder drainage (EGBD) has been described as a treatment option. However, whether this is an effective treatment option in surgically fit patients are uncertain.
The aim of the current study is to evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy. The investigators hypothesis that the technique is safe and feasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-guided gallbladder drainage (EGBD) | Experimental | Device: EUS-guided gallbladder drainage (EGBD)The procedure would be performed with a linear echoendoscope using a 10mm x 10mm or a 15 x 10mm stent. The distal flange of the stent would be deployed under EUS guidance, followed by deployment of the proximal flange under endoscopic guidance. Once deployed, the gallbladder would be completely emptied by suction and irrigation until the effluent through the stent is clean. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous cholecystitis indicated for laparoscopic cholecystectomy would be included.
Key exclusion criteria (9 listed)
- Pregnancy
- Patients unwilling to undergo follow-up assessments
- Patients with suspected gangrene or perforation of the gallbladder
- Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
- Patients with duodenal obstruction
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 |
|---|---|---|
| EUS-guided gallbladder drainage (EGBD)As listed in the arms description | Device | EUS-guided gallbladder drainage (EGBD) |
Primary outcome
Clinical success rate
Time frame: 30 days
Complete resolution of acute cholecystitis as defined by resolution of fever, pain and change of white cell counts of 10%
6 secondary outcomes
Technical success rate
Time frame: 30 days
30-day adverse events rate
Time frame: 30 days
Stone or polyp recurrences
Time frame: 3 years
Quality of life scores: Gastrointestinal quality of life index
Time frame: 3 years
Mortality rate
Time frame: 3 years
Reintervention rate
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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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. This study is not recruiting at the moment.
Anthony Teoh principal investigator
CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided gallbladder drainage (EGBD) in people with Acute Cholecystitis, run by Chinese University of Hong Kong at 1 site in China.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 20 Mar 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success rate (time frame: 30 days). 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 Mar 2026.