Brief Title
The Role of Ultrasound in Cholecystitis
Official Title
The Role of Ultrasound in Cholecystitis
Brief 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.
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 Type
Observational
Primary Outcome
Does the gallbladder wall thickness in acute cholecystitis change over time?
Secondary Outcome
Does the gallbladder volume in acute cholecystitis change over time?
Condition
Cholecystitis, Acute
Study Arms / Comparison Groups
Ultrasound
Description: All included patients will be examined with ultrasound
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
120
Start Date
October 23, 2017
Completion Date
November 30, 2018
Primary Completion Date
November 30, 2018
Eligibility Criteria
Inclusion Criteria:
- Acute cholecystitis according to the Tokyo Guidelines 2013 criteria
Exclusion Criteria:
- Difficulties to communicate
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Anders Sonden, Docent, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT03470220
Organization ID
2017/1222-31/2
Responsible Party
Principal Investigator
Study Sponsor
Karolinska Institutet
Study Sponsor
Anders Sonden, Docent, Study Director, Karolinska Instistutet Södersjukhuset
Verification Date
February 2019