NCT03470220

Brief Summary

The aim of this study is:

  1. 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. 2.To investigate if there is anything in the ultrasound picture that can predict a difficult operation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

November 28, 2017

Last Update Submit

February 25, 2019

Conditions

Cholecystitis, Acute

Outcome Measures

Primary Outcomes (1)

  • Does the gallbladder wall thickness in acute cholecystitis change over time?

    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 Outcomes (2)

  • Does the gallbladder volume in acute cholecystitis change over time?

    Through study completion, one year

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

    Through study completion, one year

Other Outcomes (1)

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

    Through study completion, one year

Study Arms (1)

Ultrasound

All included patients will be examined with ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Acute cholecystitis according to the Tokyo Guidelines 2013 criteria

You may not qualify if:

  • Difficulties to communicate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Södersjukhuset

Stockholm, Stockholm County, S-11883, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 23340953BACKGROUND

  • 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.

    PMID: 23307001BACKGROUND

  • 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.

    PMID: 23307006BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Anders Sonden, Docent

    Karolinska Instistutet Södersjukhuset

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Principal Investigator

Study Record Dates

First Submitted

November 28, 2017

First Posted

March 19, 2018

Study Start

October 23, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

SE(1)