CholecystitisNCT01146743
Prospective Trial for Endoscopic Ultrasound Guided Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
A study testing EUS-guided gallbladder drainage and percutaneous transhepatic gallbladder drainage in people with Cholecystitis, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The investigators would like to conduct a prospective, randomized non-inferiority study to compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis
- What is being tested?
- EUS-guided gallbladder drainage and percutaneous transhepatic gallbladder drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2010to Mar 2011
- 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
- high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)
Who cannot join
- Age below 18 years
- Pregnancy
- When the risks of endoscopy to patient are judged to outweigh the most favorable benefits of the procedure.
- Unstable or unwilling to comply with follow-up
- When a perforated viscus is known or suspected
- Simultaneously participating in another investigational drug or device study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial for Endoscopic Ultrasound Guided and Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
The investigators would like to conduct a prospective, randomized non-inferiority study to compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis patients.
Read the detailed description
The primary outcome is to compare clinical resolution rate of EUS-guided gallbladder drainage versus percutaneous transhepatic gallbladder drainage in acute cholecystitis patients with high risk.
The secondary outcome is to compare complications, conversion rate to open cholecystectomy during laparoscopic cholecystectomy.
- Conditions
- Cholecystitis
- Being tested
- EUS-guided gallbladder drainage, percutaneous transhepatic gallbladder drainage
- Keywords
- EUS-guided transmural cholecystostomy
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided gallbladder drainageProcedure or surgery
Also called EUS-guided transmural drainage
EUS-guided gallbladder drainage was performed with a linear-array echoendoscope. The initial puncture was performed at the antrum of the stomach or bulb of the duodenum and was chosen to access the gallbladder body or neck and avoid visible vessels. After removal of the needle, a 6F or 7F bougie were inserted and then removed to dilate the tract. Afterward, nasobiliary drainage tube or stent was placed.
percutaneous transhepatic gallbladder drainageProcedure or surgery
Also called percutaneous cholecystostomy
Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.
| Study group | Role | What they receive |
|---|---|---|
| EUS-guided | Active comparator | EUS-guided gallbladder drainage in acute cholecystitis with high risk patients Receives: Procedure: EUS-guided gallbladder drainage |
| percutaneous transhepatic | Active comparator | percutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients Receives: Procedure: percutaneous transhepatic gallbladder drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate
Definition of clinical response rate within 72 hours from procedure was improvement of local signs and systemic signs of inflammation.
Measured: Within 72 hours from procedure
Secondary outcomes (2)
Complication rate
Complication was defined as any procedure-related complications during the procedure or within 1 week, including bile leakage, pneumoperitoneum, bleeding, and etc.
Measured: Complications during the procedure or within 1 weeks
Conversion rate
Conversion was defined as conversion to open cholecystectomy during laparoscopic cholecystectomy.
Measured: During laparoscopic cholectstectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- SangSoo Lee, M.D., Study director, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146743
- Sponsor's protocol ID
- EUS_GB1
- Status last verified
- Mar 2011
- First submitted
- 9 Jun 2010
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee SS, Park DH, Hwang CY, Ahn CS, Lee TY, Seo DW, Lee SK, Kim MW. EUS-guided transmural cholecystostomy as rescue management for acute cholecystitis in elderly or high-risk patients: a prospective feasibility study. Gastrointest Endosc. 2007 Nov;66(5):1008-12. doi: 10.1016/j.gie.2007.03.1080. Epub 2007 Sep 4.
PubMed 17767933
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial for Endoscopic Ultrasound Guided and Percutaneous Transhepatic Gallbladder Drainage for Acute Cholecystitis in High Risk Patients
- ClinicalTrials.gov ID
- NCT01146743
- Acronym / sponsor ID
- EUS_GB1
- Conditions
- Cholecystitis
- Keywords
- EUS-guided transmural cholecystostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 22 Jun 2010 (estimated)
- 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 investigators would like to conduct a prospective, randomized non-inferiority study to compare clinical outcome between endoscopic ultrasound (EUS) guided gallbladder drainage and percutaneous transhepatic gallbladder drainage (PTGBD) in high risk acute cholecystitis patients.
Detailed description
The primary outcome is to compare clinical resolution rate of EUS-guided gallbladder drainage versus percutaneous transhepatic gallbladder drainage in acute cholecystitis patients with high risk.
The secondary outcome is to compare complications, conversion rate to open cholecystectomy during laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-guided | Active comparator | Procedure: EUS-guided gallbladder drainageEUS-guided gallbladder drainage in acute cholecystitis with high risk patients |
| percutaneous transhepatic | Active comparator | Procedure: percutaneous transhepatic gallbladder drainagepercutaneous transhepatic gallbladder drainage in acute cholecystitis with high risk patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- high risk for general anesthesia and emergency operation (American Society of Anesthesiologists, ASA grade III or IV)
Key exclusion criteria (6 listed)
- Age below 18 years
- Pregnancy
- When the risks of endoscopy to patient are judged to outweigh the most favorable benefits of the procedure.
- Unstable or unwilling to comply with follow-up
- When a perforated viscus is known or suspected
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 drainageAlso: EUS-guided transmural drainageEUS-guided gallbladder drainage was performed with a linear-array echoendoscope. The initial puncture was performed at the antrum of the stomach or bulb of the duodenum and was chosen to access the gallbladder body or neck and avoid visible vessels. After removal of the needle, a 6F or 7F bougie were inserted and then removed to dilate the tract. Afterward, nasobiliary drainage tube or stent was placed. | Procedure or surgery | EUS-guided |
| percutaneous transhepatic gallbladder drainageAlso: percutaneous cholecystostomyUnder ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route. | Procedure or surgery | percutaneous transhepatic |
Primary outcome
Clinical response rate
Time frame: Within 72 hours from procedure
Definition of clinical response rate within 72 hours from procedure was improvement of local signs and systemic signs of inflammation.
2 secondary outcomes
Complication rate
Time frame: Complications during the procedure or within 1 weeks
Conversion rate
Time frame: During laparoscopic cholectstectomy
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 17 Mar 2011.
- Background: PubMed 17767933Lee SS, Park DH, Hwang CY, Ahn CS, Lee TY, Seo DW, Lee SK, Kim MW. EUS-guided transmural cholecystostomy as rescue management for acute cholecystitis in elderly or high-risk patients: a prospective feasibility study. Gastrointest Endosc. 2007 Nov;66(5):1008-12. doi: 10.1016/j.gie.2007.03.1080. Epub 2007 Sep 4.
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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.
SangSoo Lee, M.D. study director
Asan Medical Center
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 and percutaneous transhepatic gallbladder drainage in people with Cholecystitis, run by Asan Medical Center 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 1 inclusion and 6 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 17 Mar 2011. 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?
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 response rate (time frame: Within 72 hours from procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01146743, which also lists 1 linked publication.
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 17 Mar 2011.