The Role of Ultrasound in Cholecystitis

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.

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

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