Calculous CholecystitisNCT05712733
Cholecystitis From a Microbiological and Histopathological Perspective
An observational study of Calculous Cholecystitis and Antibiotic Resistant Infection, run by Organkirurgisk afdeling, sygehus lillebælt, Kolding at 1 site in Denmark.
Trial summary
The aim of this project is to investigate the presence of bacteria in the gallbladder wall and the bile in patients undergoing cholecystectomy, to determine if the standard empirical antibiotic treatment used currently is effective against the most common pathogens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Calculous Cholecystitis, Antibiotic Resistant Infection, Gallbladder Inflammation
- What is being tested?
- Microbiological and histopathological investigation of bile and gallbladder wall specimens.
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2023to Oct 2025
- How long will I take part?
- 14 Days
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The following data will be collected for all included patients: * Age * Sex * Weight * Height * BMI * Smoking * Alcohol * Diabetes * Cardiovascular disease * Preoperative blood samples * Use of antibiotic within the last year - what type and duration of treatment * Number of days with symptoms prior to the cholecystectomy * Vitals (blood pressure, pulse, saturation, respiratory rate, temperature) * Blood culture prior to the procedure in the case group
Who may be able to join
- Age above 18 years
- Signed consent form
- Patients having cholecystectomy performed at the Department of Surgery, Sygehus Lillebælt, Kolding.
Who cannot join
- Administration of any type of antibiotics one month prior to surgery in the control group.
- Previous instrumentation of the bileducts
- Previous clinical acute cholecystitis treated conservatively with antibiotics
- Patients will be precluded from the studypopulation in cases of pPerioperative perforation of the gallbladder, or conversion to open cholecystectomy or in cases of failed attempts to extract bile or samples from the gallbladder wall.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Sygehus Lillebælt
Kolding, 6000
Malene Børgager Dissing, 76360456, malene.borgager@rsyd.dk
About this study
The aim of this project is to investigate the presence of bacteria in the gallbladder wall and the bile in patients undergoing cholecystectomy, to determine if the standard empirical antibiotic treatment used currently is effective against the most common pathogens.
Read the detailed description
The investigators will compare two groups of patients; patients with acute calculous cholecystitis undergoing acute laparoscopic cholecystectomy and patients without cholecystitis undergoing elective laparoscopic cholecystectomy.
Secondly, the investigators wish to investigate if the presence of bacteria correlates with the grade of inflammation, and whether this can predict when cholecystitis is caused by infection.
In a clinical setting, this can provide important knowledge regarding the choice of antibiotics currently used to treat and prevent infection in the gallbladder.
The investigators will conduct two studies, one investigating the bacteria in bile and in the gallbladder wall and the resistens of the bacteria to antibiotics and another study investigating the histopathology of the gallbladder wall to see if the bacteria present is the cause of inflammation or an actual infection.
- Being tested
- Microbiological and histopathological investigation of bile and gallbladder wall specimens.
- Medical subject headings
- Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological and histopathological investigation of bile and gallbladder wall specimens.Other
Bile and gallbladder wall specimens will be taken from all patients included in the study. The material will be sent for microbiological and histopathological investigation.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Patients suffering from acute calculous cholecystitis undergoing subacute laparoscopic cholecystectomy.
Samples of bile and gallbladder wall specimens will be taken during surgery and will be sent for microbiological and pathological investigation Receives: Other: Microbiological and histopathological investigation of bile and gallbladder wall specimens. | |
| Control group | Patients suffering from painattacks due to gallstones, who have not symptoms of cholecystitis. The patients will undergo elective laparoscopic cholecystectomy.
Samples of bile and gallbladder wall specimens will be taken during surgery and will be sent for microbiological and pathological investigation Receives: Other: Microbiological and histopathological investigation of bile and gallbladder wall specimens. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial colonization in bile and gallbladder wall samples
Microbiological investigation of microorganisms present in the bile and in the gallbladder wall.
Bile samples will be collected by puncturing the gallbladder either perioperatively or immediate after extraction of the gallbladder from the abdomen. This is done in a sterile manner using a syringe.
The gallbladder wall specimens are collected immediately after extraction of the gallbladder from the abdomen. Three samples will be taken from macroscopic normal looking parts of the posterior wall in the fundus area using a sterile 4 mm punch biopsy.
Bile samples and punch biopsies sent to the Department of Clinical Microbiology, SLB, will be cultured on selected agar growth media and incubated under aerobic, microaerophilic, and anaerobic conditions.
Bacterial colonies will be identified and quantified using routine laboratory methods.
Measured: 36-72 hours
Antibiotic resistans
Microbiological investigation of antibiotic resistans of the bacteria, if any, present in bile and gallbladder wall specimens.
Antimicrobial susceptibility testing will be performed using the disk diffusion method.
To determine the possible presence of inhibitory concentrations of antibiotics in the bile samples, a droplet of bile from each sample will be added to an agar plate inoculated with the E. coli ATCC 25922-strain. After incubation, the appearance of a growth inhibition zone will be measured.
Measured: 36-72 hours
Histopathology of the gallbladder
Histopathological investigation of the gallbladder to investigate if there is either inflammation or an actual infection and correlate these findings to the bacterial colonization.
The gallbladder from all included patients will be sent to the Department of Pathology, SLB, for evaluation of the grade of inflammation.
After formalin fixation sections from the cystic duct, the corpus and the fundus area will be sampled. The sections will be embedded in paraffin and will be cut into thin slices, which will be dyed with hematoxylin and eosin. The grade of acute inflammation will be assessed in a semi quantitative manner:
Grade 1: superficial ulceration of the mucosa concomitant with light infiltration by neutrophile granulocytes Grade 2: infiltration by granulocytes, spreading into the deeper layers of the gallbladder wall.
Grade 3: profound necrosis, extending through the entire gallbladder wall.
Measured: 3-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Apr 2023
- Primary completionJun 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Calculous CholecystitisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Organkirurgisk afdeling, sygehus lillebælt, Kolding
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Malene Borgager Dissing, Organkirurgisk afdeling, sygehus lillebælt, Kolding
- Investigators
- Malene B Dissing, MD, Principal investigator, Organkirurgisk afdeling, sygehus lillebælt, Kolding
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712733
- Sponsor's protocol ID
- MBDissing
- Status last verified
- Apr 2024
- First submitted
- 16 Jan 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kimura Y, Takada T, Kawarada Y, Nimura Y, Hirata K, Sekimoto M, Yoshida M, Mayumi T, Wada K, Miura F, Yasuda H, Yamashita Y, Nagino M, Hirota M, Tanaka A, Tsuyuguchi T, Strasberg SM, Gadacz TR. Definitions, pathophysiology, and epidemiology of acute cholangitis and cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):15-26. doi: 10.1007/s00534-006-1152-y. Epub 2007 Jan 30.
PubMed 17252293Indar AA, Beckingham IJ. Acute cholecystitis. BMJ. 2002 Sep 21;325(7365):639-43. doi: 10.1136/bmj.325.7365.639. No abstract available.
PubMed 12242178Halpin V. Acute cholecystitis. BMJ Clin Evid. 2014 Aug 20;2014:0411.
PubMed 25144428Lou MA, Mandal AK, Alexander JL, Thadepalli H. Bacteriology of the human biliary tract and the duodenum. Arch Surg. 1977 Aug;112(8):965-7. doi: 10.1001/archsurg.1977.01370080063010.
PubMed 195558Fukunaga FH. Gallbladder bacteriology, histology, and gallstones. Study of unselected cholecystectomy specimens in Honolulu. Arch Surg. 1973 Feb;106(2):169-71. doi: 10.1001/archsurg.1973.01350140033011. No abstract available.
PubMed 4346851Sianesi M, Berri T. [Bacteriological studies on the bile in different conditions of surgical interest]. Chir Ital. 1976 Aug;28(4):341-55. Italian.
PubMed 1009648Brody LA, Brown KT, Getrajdman GI, Kannegieter LS, Brown AE, Fong Y, Blumgart LH. Clinical factors associated with positive bile cultures during primary percutaneous biliary drainage. J Vasc Interv Radiol. 1998 Jul-Aug;9(4):572-8. doi: 10.1016/s1051-0443(98)70324-0.
PubMed 9684825Siegman-Igra Y, Schwartz D, Konforti N, Perluk C, Rozin RR. Septicemia from biliary tract infection. Arch Surg. 1988 Mar;123(3):366-8. doi: 10.1001/archsurg.1988.01400270106016.
PubMed 3341915Park JW, Lee JK, Lee KT, Lee KH, Sung YK, Kang CI. How to interpret the bile culture results of patients with biliary tract infections. Clin Res Hepatol Gastroenterol. 2014 Jun;38(3):300-9. doi: 10.1016/j.clinre.2014.02.005. Epub 2014 Mar 24.
PubMed 24674840Rupp C, Bode K, Weiss KH, Rudolph G, Bergemann J, Kloeters-Plachky P, Chahoud F, Stremmel W, Gotthardt DN, Sauer P. Microbiological Assessment of Bile and Corresponding Antibiotic Treatment: A Strobe-Compliant Observational Study of 1401 Endoscopic Retrograde Cholangiographies. Medicine (Baltimore). 2016 Mar;95(10):e2390. doi: 10.1097/MD.0000000000002390.
PubMed 26962768Suh SW, Choi YS, Choi SH, Do JH, Oh HC, Kim HJ, Lee SE. Antibiotic selection based on microbiology and resistance profiles of bile from gallbladder of patients with acute cholecystitis. Sci Rep. 2021 Feb 3;11(1):2969. doi: 10.1038/s41598-021-82603-8.
PubMed 33536564Capoor MR, Nair D, Rajni, Khanna G, Krishna SV, Chintamani MS, Aggarwal P. Microflora of bile aspirates in patients with acute cholecystitis with or without cholelithiasis: a tropical experience. Braz J Infect Dis. 2008 Jun;12(3):222-5. doi: 10.1590/s1413-86702008000300012.
PubMed 18839486Gipson KS, Nickerson KP, Drenkard E, Llanos-Chea A, Dogiparthi SK, Lanter BB, Hibbler RM, Yonker LM, Hurley BP, Faherty CS. The Great ESKAPE: Exploring the Crossroads of Bile and Antibiotic Resistance in Bacterial Pathogens. Infect Immun. 2020 Sep 18;88(10):e00865-19. doi: 10.1128/IAI.00865-19. Print 2020 Sep 18.
PubMed 32661122Kwon W, Jang JY, Kim EC, Park JW, Han IW, Kang MJ, Kim SW. Changing trend in bile microbiology and antibiotic susceptibilities: over 12 years of experience. Infection. 2013 Feb;41(1):93-102. doi: 10.1007/s15010-012-0358-y. Epub 2012 Nov 21.
PubMed 23180506Begley M, Gahan CG, Hill C. The interaction between bacteria and bile. FEMS Microbiol Rev. 2005 Sep;29(4):625-51. doi: 10.1016/j.femsre.2004.09.003.
PubMed 16102595
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholecystitis From a Microbiological and Histopathological Perspective
- ClinicalTrials.gov ID
- NCT05712733
- Acronym / sponsor ID
- MBDissing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Organkirurgisk afdeling, sygehus lillebælt, KoldingResearch network
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 3 Feb 2023 (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 aim of this project is to investigate the presence of bacteria in the gallbladder wall and the bile in patients undergoing cholecystectomy, to determine if the standard empirical antibiotic treatment used currently is effective against the most common pathogens.
Detailed description
The investigators will compare two groups of patients; patients with acute calculous cholecystitis undergoing acute laparoscopic cholecystectomy and patients without cholecystitis undergoing elective laparoscopic cholecystectomy.
Secondly, the investigators wish to investigate if the presence of bacteria correlates with the grade of inflammation, and whether this can predict when cholecystitis is caused by infection.
In a clinical setting, this can provide important knowledge regarding the choice of antibiotics currently used to treat and prevent infection in the gallbladder.
The investigators will conduct two studies, one investigating the bacteria in bile and in the gallbladder wall and the resistens of the bacteria to antibiotics and another study investigating the histopathology of the gallbladder wall to see if the bacteria present is the cause of inflammation or an actual infection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Microbiological and histopathological investigation of bile and gallbladder wall specimens.Patients suffering from acute calculous cholecystitis undergoing subacute laparoscopic cholecystectomy. Samples of bile and gallbladder wall specimens will be taken during surgery and will be sent for microbiological and pathological investigation |
| Control group | – | Other: Microbiological and histopathological investigation of bile and gallbladder wall specimens.Patients suffering from painattacks due to gallstones, who have not symptoms of cholecystitis. The patients will undergo elective laparoscopic cholecystectomy. Samples of bile and gallbladder wall specimens will be taken during surgery and will be sent for microbiological and pathological investigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The following data will be collected for all included patients: * Age * Sex * Weight * Height * BMI * Smoking * Alcohol * Diabetes * Cardiovascular disease * Preoperative blood samples * Use of antibiotic within the last year - what type and duration of treatment * Number of days with symptoms prior to the cholecystectomy * Vitals (blood pressure, pulse, saturation, respiratory rate, temperature) * Blood culture prior to the procedure in the case group
Key inclusion criteria (3 listed)
- Age above 18 years
- Signed consent form
- Patients having cholecystectomy performed at the Department of Surgery, Sygehus Lillebælt, Kolding.
Key exclusion criteria (4 listed)
- Administration of any type of antibiotics one month prior to surgery in the control group.
- Previous instrumentation of the bileducts
- Previous clinical acute cholecystitis treated conservatively with antibiotics
- Patients will be precluded from the studypopulation in cases of pPerioperative perforation of the gallbladder, or conversion to open cholecystectomy or in cases of failed attempts to extract bile or samples from the gallbladder wall.
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 |
|---|---|---|
| Microbiological and histopathological investigation of bile and gallbladder wall specimens.Bile and gallbladder wall specimens will be taken from all patients included in the study. The material will be sent for microbiological and histopathological investigation. | Other | Case group, Control group |
Primary outcome
Bacterial colonization in bile and gallbladder wall samples
Time frame: 36-72 hours
Microbiological investigation of microorganisms present in the bile and in the gallbladder wall. Bile samples will be collected by puncturing the gallbladder either perioperatively or immediate after extraction of the gallbladder from the abdomen. This is done in a sterile manner using a syringe. The gallbladder wall specimens are collected immediately after extraction of the gallbladder from the abdomen. Three samples will be taken from macroscopic normal looking parts of the posterior wall in the fundus area using a sterile 4 mm punch biopsy. Bile samples and punch biopsies sent to the Department of Clinical Microbiology, SLB, will be cultured on selected agar growth media and incubated under aerobic, microaerophilic, and anaerobic conditions. Bacterial colonies will be identified and quantified using routine laboratory methods.
Antibiotic resistans
Time frame: 36-72 hours
Microbiological investigation of antibiotic resistans of the bacteria, if any, present in bile and gallbladder wall specimens. Antimicrobial susceptibility testing will be performed using the disk diffusion method. To determine the possible presence of inhibitory concentrations of antibiotics in the bile samples, a droplet of bile from each sample will be added to an agar plate inoculated with the E. coli ATCC 25922-strain. After incubation, the appearance of a growth inhibition zone will be measured.
Histopathology of the gallbladder
Time frame: 3-21 days
Histopathological investigation of the gallbladder to investigate if there is either inflammation or an actual infection and correlate these findings to the bacterial colonization. The gallbladder from all included patients will be sent to the Department of Pathology, SLB, for evaluation of the grade of inflammation. After formalin fixation sections from the cystic duct, the corpus and the fundus area will be sampled. The sections will be embedded in paraffin and will be cut into thin slices, which will be dyed with hematoxylin and eosin. The grade of acute inflammation will be assessed in a semi quantitative manner: Grade 1: superficial ulceration of the mucosa concomitant with light infiltration by neutrophile granulocytes Grade 2: infiltration by granulocytes, spreading into the deeper layers of the gallbladder wall. Grade 3: profound necrosis, extending through the entire gallbladder wall.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Background: PubMed 17252293Kimura Y, Takada T, Kawarada Y, Nimura Y, Hirata K, Sekimoto M, Yoshida M, Mayumi T, Wada K, Miura F, Yasuda H, Yamashita Y, Nagino M, Hirota M, Tanaka A, Tsuyuguchi T, Strasberg SM, Gadacz TR. Definitions, pathophysiology, and epidemiology of acute cholangitis and cholecystitis: Tokyo Guidelines. J Hepatobiliary Pancreat Surg. 2007;14(1):15-26. doi: 10.1007/s00534-006-1152-y. Epub 2007 Jan 30.
- Background: PubMed 12242178Indar AA, Beckingham IJ. Acute cholecystitis. BMJ. 2002 Sep 21;325(7365):639-43. doi: 10.1136/bmj.325.7365.639. No abstract available.
- Background: PubMed 25144428Halpin V. Acute cholecystitis. BMJ Clin Evid. 2014 Aug 20;2014:0411.
- Background: PubMed 195558Lou MA, Mandal AK, Alexander JL, Thadepalli H. Bacteriology of the human biliary tract and the duodenum. Arch Surg. 1977 Aug;112(8):965-7. doi: 10.1001/archsurg.1977.01370080063010.
- Background: PubMed 4346851Fukunaga FH. Gallbladder bacteriology, histology, and gallstones. Study of unselected cholecystectomy specimens in Honolulu. Arch Surg. 1973 Feb;106(2):169-71. doi: 10.1001/archsurg.1973.01350140033011. No abstract available.
- Background: PubMed 1009648Sianesi M, Berri T. [Bacteriological studies on the bile in different conditions of surgical interest]. Chir Ital. 1976 Aug;28(4):341-55. Italian.
- Background: PubMed 9684825Brody LA, Brown KT, Getrajdman GI, Kannegieter LS, Brown AE, Fong Y, Blumgart LH. Clinical factors associated with positive bile cultures during primary percutaneous biliary drainage. J Vasc Interv Radiol. 1998 Jul-Aug;9(4):572-8. doi: 10.1016/s1051-0443(98)70324-0.
- Background: PubMed 3341915Siegman-Igra Y, Schwartz D, Konforti N, Perluk C, Rozin RR. Septicemia from biliary tract infection. Arch Surg. 1988 Mar;123(3):366-8. doi: 10.1001/archsurg.1988.01400270106016.
- Background: PubMed 24674840Park JW, Lee JK, Lee KT, Lee KH, Sung YK, Kang CI. How to interpret the bile culture results of patients with biliary tract infections. Clin Res Hepatol Gastroenterol. 2014 Jun;38(3):300-9. doi: 10.1016/j.clinre.2014.02.005. Epub 2014 Mar 24.
- Background: PubMed 26962768Rupp C, Bode K, Weiss KH, Rudolph G, Bergemann J, Kloeters-Plachky P, Chahoud F, Stremmel W, Gotthardt DN, Sauer P. Microbiological Assessment of Bile and Corresponding Antibiotic Treatment: A Strobe-Compliant Observational Study of 1401 Endoscopic Retrograde Cholangiographies. Medicine (Baltimore). 2016 Mar;95(10):e2390. doi: 10.1097/MD.0000000000002390.
- Background: PubMed 33536564Suh SW, Choi YS, Choi SH, Do JH, Oh HC, Kim HJ, Lee SE. Antibiotic selection based on microbiology and resistance profiles of bile from gallbladder of patients with acute cholecystitis. Sci Rep. 2021 Feb 3;11(1):2969. doi: 10.1038/s41598-021-82603-8.
- Background: PubMed 18839486Capoor MR, Nair D, Rajni, Khanna G, Krishna SV, Chintamani MS, Aggarwal P. Microflora of bile aspirates in patients with acute cholecystitis with or without cholelithiasis: a tropical experience. Braz J Infect Dis. 2008 Jun;12(3):222-5. doi: 10.1590/s1413-86702008000300012.
- 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. This study is not recruiting at the moment.
Malene B Dissing, MD principal investigator
Organkirurgisk afdeling, sygehus lillebælt, Kolding
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 Calculous Cholecystitis and Antibiotic Resistant Infection, run by Organkirurgisk afdeling, sygehus lillebælt, Kolding at 1 site in Denmark.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Apr 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Malene B Dissing, MD (004528745840, malene.borgager@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial colonization in bile and gallbladder wall samples (time frame: 36-72 hours). The study lists 3 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 NCT05712733, which also lists 28 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 15 Apr 2024.