Cholecystitis, AcuteNCT03470220
The Role of Ultrasound in Cholecystitis
An observational study of Cholecystitis, Acute, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this study is: 1. To describe the natural course of acute cholecystitis, by performing repeated ultrasound examinations from day of admission to hospital until day of surgery or discharge. 2. To investigate if there is anything in the ultrasound picture that can predict a difficult operation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholecystitis, Acute
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 23 Oct 2017to 30 Nov 2018
- 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: Patients admitted to the hospital, with confirmed acute cholecystitis according to the Tokyo Guidelines 2013 will be asked to participate in the study
Who may be able to join
- Acute cholecystitis according to the Tokyo Guidelines 2013 criteria
Who cannot join
- Difficulties to communicate
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is:
- To describe the natural course of acute cholecystitis, by performing repeated ultrasound examinations from day of admission to hospital until day of surgery or discharge.
- To investigate if there is anything in the ultrasound picture that can predict a difficult operation.
Read more
Patients will be prospectively enrolled. The ultrasound picture (ultrasound variables: gallbladder volume, gallbladder wall thickness, and presence of oedema in the gallbladder wall), will be compared to clinical variables (tenderness in right upper quadrant, WBC, CRP and temperature) and to the time (hours) from onset of symptoms. Statistical analyses will be made to see if statistically significant, and clinically relevant, associations between variables exist.
Furthermore, for participants receiving acute surgery, an upper GI surgeon will evaluate the operation as easy, intermediate or difficult. In extension, investigators will look at associations between difficult surgery and all the variables previously mentioned (both ultrasound variables, clinical variables and time).
Read the detailed description
Patients admitted to Stockholm South General Hospital's Surgery Department, with a confirmed diagnosis of acute cholecystitis (according to the Tokyo Guidelines 2013) will be considered eligible for the study and asked to participate. Informed consent will be obtained from all participants. Participants will be examined with ultrasound of the gallbladder daily, while receiving regular care for acute cholecystitis, which means either waiting for acute surgery or being treated conservatively for as long as inpatient care is needed.
The ultrasound examinations will be performed by a radiologist or a specialised certified ultrasound trained nurse as well as by an ultrasound trained surgeon. Measures of gallbladder volume (measured in cm3), gallbladder wall thickness (measured in mm:s) and presence of oedema in the gallbladder wall (noted as a binomial variable 'yes/no') are recorded in a case report form (no.1) together with body temperature, labs and information about onset of symptoms.
The operating surgeon (a specialist in surgery) will evaluate the operation and grade it from easy to difficult and fill in a case report form (no.2).
Data will be collected from the forms and analysed using a regression model (generalised estimated equation or a mixed model).
- Conditions
- Cholecystitis, Acute
- 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 |
|---|---|---|
| Ultrasound | All included patients will be examined with ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does the gallbladder wall thickness in acute cholecystitis change over time?
Measurement of the gallbladder wall thickness in mm will be measured daily. Association between the gallbladder wall thickness and time from onset of symptoms (hours) will be analyzed.
Measured: Through study completion, one year
Secondary outcomes (2)
Does the gallbladder volume in acute cholecystitis change over time?
Measurement of the gallbladder volume, in cm3 will be measured daily. Association between the gallbladder volume and time from onset of symptoms (hours) will be analyzed.
Measured: Through study completion, one year
Does the presence of oedema in the gallbladder wall change over time?
The presence of oedema in the gallbladder wall will be examined and noted daily.
Measured: Through study completion, one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start23 Oct 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Gustafsson, Karolinska Institutet
- Investigators
- Anders Sonden, Docent, Study director, Karolinska Instistutet Södersjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470220
- Sponsor's protocol ID
- 2017/1222-31/2
- Status last verified
- Feb 2019
- First submitted
- 28 Nov 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yokoe M, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Gomi H, Pitt HA, Garden OJ, Kiriyama S, Hata J, Gabata T, Yoshida M, Miura F, Okamoto K, Tsuyuguchi T, Itoi T, Yamashita Y, Dervenis C, Chan AC, Lau WY, Supe AN, Belli G, Hilvano SC, Liau KH, Kim MH, Kim SW, Ker CG; Tokyo Guidelines Revision Committee. TG13 diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):35-46. doi: 10.1007/s00534-012-0568-9.
PubMed 23340953Kiriyama S, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yokoe M, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan ST, Singh H, de Santibanes E, Gomi H, Kusachi S, Murata A, Chen XP, Jagannath P, Lee S, Padbury R, Chen MF, Dervenis C, Chan AC, Supe AN, Liau KH, Kim MH, Kim SW; Tokyo Guidelines Revision Committee. TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):24-34. doi: 10.1007/s00534-012-0561-3.
PubMed 23307001Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gomi H, Yoshida M, Mayumi T, Miura F, Gouma DJ, Garden OJ, Buchler MW, Kiriyama S, Yokoe M, Kimura Y, Tsuyuguchi T, Itoi T, Gabata T, Higuchi R, Okamoto K, Hata J, Murata A, Kusachi S, Windsor JA, Supe AN, Lee S, Chen XP, Yamashita Y, Hirata K, Inui K, Sumiyama Y; Tokyo Guidelines Revision Committee. TG13: Updated Tokyo Guidelines for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):1-7. doi: 10.1007/s00534-012-0566-y.
PubMed 23307006
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ultrasound in Cholecystitis
- ClinicalTrials.gov ID
- NCT03470220
- Acronym / sponsor ID
- 2017/1222-31/2
- Conditions
- Cholecystitis, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 19 Mar 2018 (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 study is:
- To describe the natural course of acute cholecystitis, by performing repeated ultrasound examinations from day of admission to hospital until day of surgery or discharge.
- To investigate if there is anything in the ultrasound picture that can predict a difficult operation.
Patients will be prospectively enrolled. The ultrasound picture (ultrasound variables: gallbladder volume, gallbladder wall thickness, and presence of oedema in the gallbladder wall), will be compared to clinical variables (tenderness in right upper quadrant, WBC, CRP and temperature) and to the time (hours) from onset of symptoms. Statistical analyses will be made to see if statistically significant, and clinically relevant, associations between variables exist.
Furthermore, for participants receiving acute surgery, an upper GI surgeon will evaluate the operation as easy, intermediate or difficult. In extension, investigators will look at associations between difficult surgery and all the variables previously mentioned (both ultrasound variables, clinical variables and time).
Detailed description
Patients admitted to Stockholm South General Hospital's Surgery Department, with a confirmed diagnosis of acute cholecystitis (according to the Tokyo Guidelines 2013) will be considered eligible for the study and asked to participate. Informed consent will be obtained from all participants. Participants will be examined with ultrasound of the gallbladder daily, while receiving regular care for acute cholecystitis, which means either waiting for acute surgery or being treated conservatively for as long as inpatient care is needed.
The ultrasound examinations will be performed by a radiologist or a specialised certified ultrasound trained nurse as well as by an ultrasound trained surgeon. Measures of gallbladder volume (measured in cm3), gallbladder wall thickness (measured in mm:s) and presence of oedema in the gallbladder wall (noted as a binomial variable 'yes/no') are recorded in a case report form (no.1) together with body temperature, labs and information about onset of symptoms.
The operating surgeon (a specialist in surgery) will evaluate the operation and grade it from easy to difficult and fill in a case report form (no.2).
Data will be collected from the forms and analysed using a regression model (generalised estimated equation or a mixed model).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | – | –All included patients will be examined with ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital, with confirmed acute cholecystitis according to the Tokyo Guidelines 2013 will be asked to participate in the study
Key inclusion criteria (1 listed)
- Acute cholecystitis according to the Tokyo Guidelines 2013 criteria
Key exclusion criteria (1 listed)
- Difficulties to communicate
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
Does the gallbladder wall thickness in acute cholecystitis change over time?
Time frame: Through study completion, one year
Measurement of the gallbladder wall thickness in mm will be measured daily. Association between the gallbladder wall thickness and time from onset of symptoms (hours) will be analyzed.
2 secondary outcomes
Does the gallbladder volume in acute cholecystitis change over time?
Time frame: Through study completion, one year
Does the presence of oedema in the gallbladder wall change over time?
Time frame: Through study completion, one year
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 26 Feb 2019.
- Background: PubMed 23340953Yokoe M, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Gomi H, Pitt HA, Garden OJ, Kiriyama S, Hata J, Gabata T, Yoshida M, Miura F, Okamoto K, Tsuyuguchi T, Itoi T, Yamashita Y, Dervenis C, Chan AC, Lau WY, Supe AN, Belli G, Hilvano SC, Liau KH, Kim MH, Kim SW, Ker CG; Tokyo Guidelines Revision Committee. TG13 diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):35-46. doi: 10.1007/s00534-012-0568-9.
- Background: PubMed 23307001Kiriyama S, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yokoe M, Kimura Y, Tsuyuguchi T, Itoi T, Yoshida M, Miura F, Yamashita Y, Okamoto K, Gabata T, Hata J, Higuchi R, Windsor JA, Bornman PC, Fan ST, Singh H, de Santibanes E, Gomi H, Kusachi S, Murata A, Chen XP, Jagannath P, Lee S, Padbury R, Chen MF, Dervenis C, Chan AC, Supe AN, Liau KH, Kim MH, Kim SW; Tokyo Guidelines Revision Committee. TG13 guidelines for diagnosis and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):24-34. doi: 10.1007/s00534-012-0561-3.
- Background: PubMed 23307006Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gomi H, Yoshida M, Mayumi T, Miura F, Gouma DJ, Garden OJ, Buchler MW, Kiriyama S, Yokoe M, Kimura Y, Tsuyuguchi T, Itoi T, Gabata T, Higuchi R, Okamoto K, Hata J, Murata A, Kusachi S, Windsor JA, Supe AN, Lee S, Chen XP, Yamashita Y, Hirata K, Inui K, Sumiyama Y; Tokyo Guidelines Revision Committee. TG13: Updated Tokyo Guidelines for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):1-7. doi: 10.1007/s00534-012-0566-y.
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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.
Anders Sonden, Docent study director
Karolinska Instistutet Södersjukhuset
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 Karolinska Institutet at 1 site in Sweden.
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 26 Feb 2019. 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 Sweden. 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?
Does the gallbladder wall thickness in acute cholecystitis change over time? (time frame: Through study completion, one year). 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 NCT03470220, which also lists 3 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 26 Feb 2019.