Cholecystitis, AcuteNCT04874103
Hong Kong Follow up Protocol After EUS Gallbladder Drainage for Acute Cholecistitis
An observational study of Cholecystitis, Acute, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
This study evaluates the long-term safety and efficacy of the Hong Kong follow up protocol in patients who will undergo drainage of the gallbladder under endoultrasonography (EUS) guidance in patients with acute cholecistitis not suitable for surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Acute
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2020to 15 Sep 2023
- Phase
- Observational
- 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
Study population: This study concerns consecutive patients undergoing EGBD using LAMS as per decision of the on call surgeons of the Emergency Surgery Department with diagnosis of acute cholecystitis, who are unsuitable for early laparoscopic cholecystectomy due to poor premorbid conditions
Who may be able to join
- Consecutive patients with acute cholechystitis unsuitable for surgery
- age ≥ 18 years old
- Written informed consent from patient or guardian who is able to understand the nature and possible consequences of the study
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)
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
- Patients with liver cirrhosis, portal hypertension and/or gastric varices
- Abnormal coagulation (INR > 1.5 and/or platelets < 50.000/mm3)
- Contraindication to perform endoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Ultrasound-guided Gallbladder Drainage in High Surgical Risk Patients With Acute Cholecystitis: Prospective Evaluation of the Hong Kong Follow up Protocol
This study evaluates the long-term safety and efficacy of the Hong Kong follow up protocol in patients who will undergo drainage of the gallbladder under endoultrasonography (EUS) guidance in patients with acute cholecistitis not suitable for surgery.
Read the detailed description
Acute cholecystitis is a common surgical condition. However, in elderly patients or patients with significant comorbidity, emergency laparoscopic cholecystectomy can be associated with significant risk of morbidities. Thus, in these patients, percutaneous cholecystostomy (PC) could be employed for drainage of the gallbladder. However, complications including intrahepatic hemorrhage, pneumothorax, biliary peritonitis and pneumonia have been reported in a mean of 6.2% of patients (range 0-25%). Furthermore, PC has several other disadvantages including risk of bile leakage, recurrent cholecystitis, inadvertent tube removal and migration (0-25%), necessitating repeated procedures. In order to avoid nuisances associated with PC, studies looking at potential ways to achieve endoscopic gallbladder drainage have been performed. On the other hand, EUS-guided transmural drainage procedures are increasingly performed for management of a variety of conditions and has also been described for drainage of the gallbladder in patients that are not fit for surgery since 2007. Recently, a lumen-apposing metal stent (LAMS) has become available which allows easier deployement of the stent. A 9.8mm gastroscope or a 5mm ultrathin nasal endoscope can pass through the lumen of the stent and enter the gallbladder for stone removal or other interventions A recent study group from Hong Kong promoted a specific follow up for EUS guided gallbaldder drainage patients who underwent a follow-up cholecystoscopy after the procedure to check for clearance of stones. In patients with stones that were too large to pass out spontaneously, basket mechanical lithotripsy was employed to break down the stones, followed by laser lithotripsy if the latter was not successful. No data on the safety and efficacy of the Hong Kong follow up protocol in patients who underwent EGBD using LAMS coming from countries other than Asian are available, in which differences in etiological and pathogenic factors might not required such an intensive follow up protocol. To explore this important question we have designed a study aimed at evaluating the long-term safety and efficacy of the Hong Kong follow up protocol in patients undergoing EGBD performed using LAMS.
- Conditions
- Cholecystitis, Acute
- Keywords
- endoscopic ultrasound, eus, acute cholecistitis, gallbladder drainage
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EUS guided gallbladder drainage and cholecystoscopy | EUS-GBD will be performed using LAMS (such as Hot-AxiosTM device). A 10mm x 10mm stent system will be used if the largest gallstone is smaller than 10mm in size and a 15 x 10mm stent will be used if the largest gallstone is larger than 10mm. Colecystoscopy will be subsequently performed after at least 2 weeks using standard or therapeutic gastroscope. Lithotripsy will be performed using mechanical lithotripsy or laser lithotripsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events after EUS gallbladder drainage and cholecystoscopy
Percentage adverse events after the procedures. Adverse events will be considered major if they prevent completion of the scheduled procedure and/or resulted in prolongation of hospital stay, another therapeutic procedure (needing sedation/anesthesia), or subsequent medical consultation. Any potential adverse event such as pancreatitis, burns of the gastric or duodenal walls, bowel injury, or peritonitis will be recorded and graded according to the above-mentioned classification.
Measured: From date of treatment every 2-3 months, assessed until death or up to 2 years
Incidence of recurrent acute cholecystitis after EUS-GBD and cholecystoscopy
Percentage of patients with recurrent acute cholecystitis symptoms after EUS-GBD and cholecystoscopy with residual stone removal if present after resolution of the index episode.
Measured: From date of treatment, every 2-3 months, assessed until death or up to 2 years
Secondary outcomes (3)
Incidence of patients with resolution of acute cholecystitis symptoms after EUS-GBD
Percetange of patients achieving acute cholecystitis symptoms resolution after EUS-GBD demonstrated by normalization of clinical parameters of acute cholecystitis within 96 hours. Clinical parameters reported are abdominal pain evaluated by the patients on a 10-point visual analogue scale, temperature, white blood cell count and serum C-reactive protein concentration.
Measured: Within 96 hours after procedure
Need for advaced gallbladder interventions
Number of patients who will require more advanced gallbladder interventions during follow up such as colecystoscopy lithotripsy will be assessed by the numebr of patients who will require such treatments.
Measured: From date of treatment, every 2-3 months, assessed until death or up to 2 years
Need for ERCP
rate of patients who will require ERCP due to stones migration during colecystoscopy will be assessed by the number of patients who will require such intervention.
Measured: From date of treatment, every 2-3 months, assessed until death or up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start6 May 2020
- Primary completion15 Jul 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guido Costamagna, Catholic University of the Sacred Heart
- Investigators
- Alberto Larghi, MD, Phd, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874103
- Sponsor's protocol ID
- EUS-GBD Hong Kong
- Status last verified
- Feb 2024
- First submitted
- 27 Apr 2021
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 17767933Keus F, Gooszen HG, van Laarhoven CJ. Open, small-incision, or laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis. An overview of Cochrane Hepato-Biliary Group reviews. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD008318. doi: 10.1002/14651858.CD008318.
PubMed 20091665Kwan V, Eisendrath P, Antaki F, Le Moine O, Deviere J. EUS-guided cholecystenterostomy: a new technique (with videos). Gastrointest Endosc. 2007 Sep;66(3):582-6. doi: 10.1016/j.gie.2007.02.065.
PubMed 17725950Teoh AYB, Serna C, Penas I, Chong CCN, Perez-Miranda M, Ng EKW, Lau JYW. Endoscopic ultrasound-guided gallbladder drainage reduces adverse events compared with percutaneous cholecystostomy in patients who are unfit for cholecystectomy. Endoscopy. 2017 Feb;49(2):130-138. doi: 10.1055/s-0042-119036. Epub 2016 Nov 22.
PubMed 27875855
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Gallbladder Drainage in High Surgical Risk Patients With Acute Cholecystitis: Prospective Evaluation of the Hong Kong Follow up Protocol
- ClinicalTrials.gov ID
- NCT04874103
- Acronym / sponsor ID
- EUS-GBD Hong Kong
- Conditions
- Cholecystitis, Acute
- Keywords
- endoscopic ultrasound, eus, acute cholecistitis, gallbladder drainage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 5 May 2021 (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.
This study evaluates the long-term safety and efficacy of the Hong Kong follow up protocol in patients who will undergo drainage of the gallbladder under endoultrasonography (EUS) guidance in patients with acute cholecistitis not suitable for surgery.
Detailed description
Acute cholecystitis is a common surgical condition. However, in elderly patients or patients with significant comorbidity, emergency laparoscopic cholecystectomy can be associated with significant risk of morbidities. Thus, in these patients, percutaneous cholecystostomy (PC) could be employed for drainage of the gallbladder. However, complications including intrahepatic hemorrhage, pneumothorax, biliary peritonitis and pneumonia have been reported in a mean of 6.2% of patients (range 0-25%). Furthermore, PC has several other disadvantages including risk of bile leakage, recurrent cholecystitis, inadvertent tube removal and migration (0-25%), necessitating repeated procedures. In order to avoid nuisances associated with PC, studies looking at potential ways to achieve endoscopic gallbladder drainage have been performed. On the other hand, EUS-guided transmural drainage procedures are increasingly performed for management of a variety of conditions and has also been described for drainage of the gallbladder in patients that are not fit for surgery since 2007. Recently, a lumen-apposing metal stent (LAMS) has become available which allows easier deployement of the stent. A 9.8mm gastroscope or a 5mm ultrathin nasal endoscope can pass through the lumen of the stent and enter the gallbladder for stone removal or other interventions A recent study group from Hong Kong promoted a specific follow up for EUS guided gallbaldder drainage patients who underwent a follow-up cholecystoscopy after the procedure to check for clearance of stones. In patients with stones that were too large to pass out spontaneously, basket mechanical lithotripsy was employed to break down the stones, followed by laser lithotripsy if the latter was not successful. No data on the safety and efficacy of the Hong Kong follow up protocol in patients who underwent EGBD using LAMS coming from countries other than Asian are available, in which differences in etiological and pathogenic factors might not required such an intensive follow up protocol. To explore this important question we have designed a study aimed at evaluating the long-term safety and efficacy of the Hong Kong follow up protocol in patients undergoing EGBD performed using LAMS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS guided gallbladder drainage and cholecystoscopy | – | –EUS-GBD will be performed using LAMS (such as Hot-AxiosTM device). A 10mm x 10mm stent system will be used if the largest gallstone is smaller than 10mm in size and a 15 x 10mm stent will be used if the largest gallstone is larger than 10mm. Colecystoscopy will be subsequently performed after at least 2 weeks using standard or therapeutic gastroscope. Lithotripsy will be performed using mechanical lithotripsy or laser lithotripsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study concerns consecutive patients undergoing EGBD using LAMS as per decision of the on call surgeons of the Emergency Surgery Department with diagnosis of acute cholecystitis, who are unsuitable for early laparoscopic cholecystectomy due to poor premorbid conditions
Key inclusion criteria (3 listed)
- Consecutive patients with acute cholechystitis unsuitable for surgery
- age ≥ 18 years old
- Written informed consent from patient or guardian who is able to understand the nature and possible consequences of the study
Key exclusion criteria (8 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)
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of adverse events after EUS gallbladder drainage and cholecystoscopy
Time frame: From date of treatment every 2-3 months, assessed until death or up to 2 years
Percentage adverse events after the procedures. Adverse events will be considered major if they prevent completion of the scheduled procedure and/or resulted in prolongation of hospital stay, another therapeutic procedure (needing sedation/anesthesia), or subsequent medical consultation. Any potential adverse event such as pancreatitis, burns of the gastric or duodenal walls, bowel injury, or peritonitis will be recorded and graded according to the above-mentioned classification.
Incidence of recurrent acute cholecystitis after EUS-GBD and cholecystoscopy
Time frame: From date of treatment, every 2-3 months, assessed until death or up to 2 years
Percentage of patients with recurrent acute cholecystitis symptoms after EUS-GBD and cholecystoscopy with residual stone removal if present after resolution of the index episode.
3 secondary outcomes
Incidence of patients with resolution of acute cholecystitis symptoms after EUS-GBD
Time frame: Within 96 hours after procedure
Need for advaced gallbladder interventions
Time frame: From date of treatment, every 2-3 months, assessed until death or up to 2 years
Need for ERCP
Time frame: From date of treatment, every 2-3 months, assessed until death or up to 2 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 14 Feb 2024.
- 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.
- Background: PubMed 20091665Keus F, Gooszen HG, van Laarhoven CJ. Open, small-incision, or laparoscopic cholecystectomy for patients with symptomatic cholecystolithiasis. An overview of Cochrane Hepato-Biliary Group reviews. Cochrane Database Syst Rev. 2010 Jan 20;2010(1):CD008318. doi: 10.1002/14651858.CD008318.
- Background: PubMed 17725950Kwan V, Eisendrath P, Antaki F, Le Moine O, Deviere J. EUS-guided cholecystenterostomy: a new technique (with videos). Gastrointest Endosc. 2007 Sep;66(3):582-6. doi: 10.1016/j.gie.2007.02.065.
- Background: PubMed 27875855Teoh AYB, Serna C, Penas I, Chong CCN, Perez-Miranda M, Ng EKW, Lau JYW. Endoscopic ultrasound-guided gallbladder drainage reduces adverse events compared with percutaneous cholecystostomy in patients who are unfit for cholecystectomy. Endoscopy. 2017 Feb;49(2):130-138. doi: 10.1055/s-0042-119036. Epub 2016 Nov 22.
- Individual participant dataSharing planned: No
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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.
Alberto Larghi, MD, Phd principal investigator
Fondazione Policlinico Universitario Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, Acute, run by Catholic University of the Sacred Heart at 1 site in Italy.
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 3 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: finished, as of the sponsor's last update on 14 Feb 2024. 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 Italy. 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?
Incidence of adverse events after EUS gallbladder drainage and cholecystoscopy (time frame: From date of treatment every 2-3 months, assessed until death or up to 2 years). The study lists 2 primary outcomes in all. 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 NCT04874103, which also lists 4 linked publications.
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 14 Feb 2024.