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Completed

NCT Number: NCT03470220

The Role of Ultrasound in Cholecystitis

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).

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Key information

Conditions

Cholecystitis, Acute Biliary Tract Diseases Cholecystitis Digestive System Diseases Gallbladder Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Södersjukhuset

Stockholm, Stockholm County, S-11883, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute cholecystitis according to the Tokyo Guidelines 2013 criteria

Exclusion criteria

  • Difficulties to communicate

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Does the gallbladder volume in acute cholecystitis change over time?

    Time frame: Through study completion, one year

    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.

  2. Does the presence of oedema in the gallbladder wall change over time?

    Time frame: Through study completion, one year

    The presence of oedema in the gallbladder wall will be examined and noted daily.

Other outcomes

  1. Does any of the ultrasound variables contribute to predict difficult surgery in acute cholecystitis?

    Time frame: Through study completion, one year

    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).

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 19, 2018
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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