The Role of Ultrasound in Cholecystitis

February 25, 2019 updated by: Camilla Gustafsson, Karolinska Institutet

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).

Study Overview

Status

Completed

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

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Stockholms LAN
      • Stockholm, Stockholms LAN, Sweden, S-11883
        • Södersjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

  • Acute cholecystitis according to the Tokyo Guidelines 2013 criteria

Exclusion Criteria:

  • Difficulties to communicate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Ultrasound
All included patients will be examined with ultrasound

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
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.
Through study completion, one year

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
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.
Through study completion, one year
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.
Through study completion, one year

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Anders Sonden, Docent, Karolinska Instistutet Södersjukhuset

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholecystitis, Acute

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