Acute Acalculous CholecystitisNCT06191471
Hepatitis A Virus Induced Acute Acalculous Cholecystitis Diagnosed Postoperatively: Case Report
An observational study of Acute Acalculous Cholecystitis, run by University of Balamand at 1 site in Lebanon.
Trial summary
41-year-old previously healthy patient presented with right upper quadrant abdominal pain. Pain started two days prior to presentation when an abdominal ultrasound in a peripheral hospital showed a 10 mm gallbladder stone with normal laboratory tests; however, her pain was resolved on analgesics. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Acute Acalculous Cholecystitis
- What is being tested?
- Laparoscopic cholecystectomy for hepatitis A induced acute acalculous cholecystitis
- How many people
- 1 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Nov 2023to 10 Dec 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 to 90 years
- Women only
- Adult, Older adult
Study population: Patients presenting with symptoms of acute acalculous cholecystitis
Who may be able to join
- acalculous cholecystitis
Who cannot join
- calculous cholecystitis
Trial locations and contacts
1 site in 1 country.
About this study
41-year-old previously healthy patient presented with right upper quadrant abdominal pain. Pain started two days prior to presentation when an abdominal ultrasound in a peripheral hospital showed a 10 mm gallbladder stone with normal laboratory tests; however, her pain was resolved on analgesics. Now the pain was persistent and associated with vomiting and laboratory tests showed elevated bilirubin. Laparoscopic cholecystectomy with intraoperative cholangiography was done that showed inflamed gallbladder but with no stones and normal cholangiography. Day one post-operation, while the pain resolved, labs showed elevated liver function tests and hepatitis workup showed acute HAV infection attributing her presentation to HAV induced AAC.
Read the detailed description
Introduction: acute acalculous cholecystitis (AAC) is defined as gallbladder inflammation without the presence of stones. Contrary, hepatitis A virus (HAV) causes acute hepatitis A and can present with different symptoms; however, HAV causing and presenting as AAC is rare.
Case presentation: 41-year-old previously healthy patient presented with right upper quadrant abdominal pain. Pain started two days prior to presentation when an abdominal ultrasound in a peripheral hospital showed a 10 mm gallbladder stone with normal laboratory tests; however, her pain was resolved on analgesics. Now the pain was persistent and associated with vomiting and laboratory tests showed elevated bilirubin. Laparoscopic cholecystectomy with intraoperative cholangiography was done that showed inflamed gallbladder but with no stones and normal cholangiography. Day one post-operation, while the pain resolved, labs showed elevated liver function tests and hepatitis workup showed acute HAV infection attributing her presentation to HAV induced AAC.
Discussion: AAC is usually caused by stasis of the gallbladder due to different causes; however, HAV as the cause of AAC has been reported. While cholecystectomy is the mainstay treatment for AAC, this might not be the case for HAV induced AAC. For instance, unless there is necrotic gallbladder or persistence of symptoms, the AAC can be managed conservatively in this case. Even though our diagnosis was cleared post-operatively, had we know the diagnosis of HAV induced AAC before, we would still opt for surgery due to the severity and persistence of pain.
Conclusion: More cases should be reported and more studies should be done to further define the presentation and management of HAV induced AAC.
- Conditions
- Acute Acalculous Cholecystitis
- Being tested
- Laparoscopic cholecystectomy for hepatitis A induced acute acalculous cholecystitis
- Keywords
- Acute acalculous cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomy for hepatitis A induced acute acalculous cholecystitisOther
Laparoscopic cholecystectomy for hepatitis A induced acute acalculous cholecystitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis A induced acute acalculous cholecystitis
Laparoscopic cholecystectomy for hepatitis A induced acute acalculous cholecystitis
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Nov 2023
- Primary completion10 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Acalculous 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 only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Balamand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Tabbikha, University of Balamand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191471
- Sponsor's protocol ID
- UBalamandAAC
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publishing a case report
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis A Virus Induced Acute Acalculous Cholecystitis Diagnosed Postoperatively: Case Report
- ClinicalTrials.gov ID
- NCT06191471
- Acronym / sponsor ID
- UBalamandAAC
- Conditions
- Acute Acalculous Cholecystitis
- Keywords
- Acute acalculous cholecystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of BalamandUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 5 Jan 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.
41-year-old previously healthy patient presented with right upper quadrant abdominal pain. Pain started two days prior to presentation when an abdominal ultrasound in a peripheral hospital showed a 10 mm gallbladder stone with normal laboratory tests; however, her pain was resolved on analgesics. Now the pain was persistent and associated with vomiting and laboratory tests showed elevated bilirubin. Laparoscopic cholecystectomy with intraoperative cholangiography was done that showed inflamed gallbladder but with no stones and normal cholangiography. Day one post-operation, while the pain resolved, labs showed elevated liver function tests and hepatitis workup showed acute HAV infection attributing her presentation to HAV induced AAC.
Detailed description
Introduction: acute acalculous cholecystitis (AAC) is defined as gallbladder inflammation without the presence of stones. Contrary, hepatitis A virus (HAV) causes acute hepatitis A and can present with different symptoms; however, HAV causing and presenting as AAC is rare.
Case presentation: 41-year-old previously healthy patient presented with right upper quadrant abdominal pain. Pain started two days prior to presentation when an abdominal ultrasound in a peripheral hospital showed a 10 mm gallbladder stone with normal laboratory tests; however, her pain was resolved on analgesics. Now the pain was persistent and associated with vomiting and laboratory tests showed elevated bilirubin. Laparoscopic cholecystectomy with intraoperative cholangiography was done that showed inflamed gallbladder but with no stones and normal cholangiography. Day one post-operation, while the pain resolved, labs showed elevated liver function tests and hepatitis workup showed acute HAV infection attributing her presentation to HAV induced AAC.
Discussion: AAC is usually caused by stasis of the gallbladder due to different causes; however, HAV as the cause of AAC has been reported. While cholecystectomy is the mainstay treatment for AAC, this might not be the case for HAV induced AAC. For instance, unless there is necrotic gallbladder or persistence of symptoms, the AAC can be managed conservatively in this case. Even though our diagnosis was cleared post-operatively, had we know the diagnosis of HAV induced AAC before, we would still opt for surgery due to the severity and persistence of pain.
Conclusion: More cases should be reported and more studies should be done to further define the presentation and management of HAV induced AAC.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with symptoms of acute acalculous cholecystitis
Key inclusion criteria (1 listed)
- acalculous cholecystitis
Key exclusion criteria (1 listed)
- calculous cholecystitis
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 |
|---|---|---|
| Laparoscopic cholecystectomy for hepatitis A induced acute acalculous cholecystitisLaparoscopic cholecystectomy for hepatitis A induced acute acalculous cholecystitis | Other | – |
Primary outcome
Hepatitis A induced acute acalculous cholecystitis
Time frame: 1 month
Laparoscopic cholecystectomy for hepatitis A induced acute acalculous cholecystitis
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 5 Jan 2024.
- Individual participant dataSharing planned: No. Publishing a case report
Related trials for Acute Acalculous Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
Cholecystitis, Acute, Biliary Diseases
Recruiting
Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage
Acute Cholecystitis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Acalculous Cholecystitis, run by University of Balamand at 1 site in Lebanon.
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 1 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 5 Jan 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 Lebanon. 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?
Hepatitis A induced acute acalculous cholecystitis (time frame: 1 month). 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 5 Jan 2024.