- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03470220
The Role of Ultrasound in Cholecystitis
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).
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Stockholms LAN
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Stockholm, Stockholms LAN, Sweden, S-11883
- Södersjukhuset
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Acute cholecystitis according to the Tokyo Guidelines 2013 criteria
Exclusion Criteria:
- Difficulties to communicate
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Ultrasound
All included patients will be examined with ultrasound
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Does the gallbladder wall thickness in acute cholecystitis change over time?
Time Frame: Through study completion, one year
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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.
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Through study completion, one year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Does the gallbladder volume in acute cholecystitis change over time?
Time Frame: Through study completion, one year
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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.
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Through study completion, one year
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Does the presence of oedema in the gallbladder wall change over time?
Time Frame: Through study completion, one year
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The presence of oedema in the gallbladder wall will be examined and noted daily.
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Through study completion, one year
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Does any of the ultrasound variables contribute to predict difficult surgery in acute cholecystitis?
Time Frame: Through study completion, one year
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Patients with acute cholecystitis who undergo surgery at the same admission will be included for further analysis. The operating surgeon (a specialist in general surgery) will classify the operation as easy, intermediate or difficult. Associations between difficult surgery, all the above listed variables and time from onset of symptoms will be calculated using a regression model (GEE or mixed model). |
Through study completion, one year
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Anders Sonden, Docent, Karolinska Instistutet Södersjukhuset
Publications and helpful links
General 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.
- Kiriyama 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.
- Takada 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/1222-31/2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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