Fluorescent Cholangiography During Acute Cholecystitis

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Cholecystitis
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Brief Title

Fluorescent Cholangiography During Acute Cholecystitis

Official Title

Prospective Comparison of Intraoperative Fluorescent and X-ray Cholangiography for Visualisation of the Bile Duct Anatomy in Patients With Acute Cholecystitis

Brief Summary

      This study compares the visualizationrate of fluorescent and X-ray cholangiography during
      laparoscopic cholecystectomy for acute cholecystitis

Study Type

Interventional

Primary Outcome

Visualizationrate

Secondary Outcome

 Visualizationrate

Condition

Acute Cholecystitis

Intervention

Cholangiography

Study Arms / Comparison Groups

 Fluorescent cholangiography
Description:  Intraoperative fluorescent cholangiography using an intravenous injection of 5mg Indocyanine green

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

200

Start Date

April 1, 2020

Completion Date

March 1, 2025

Primary Completion Date

March 1, 2024

Eligibility Criteria

        Inclusion criteria

          -  Patient scheduled for acute laparoscopic cholecystectomy due to acute cholecystitis
             with ≤ 5 days of complaints (in Denmark the national consensus for surgical window)

        Exclusion criteria

          -  Laparoscopic operation converted to open operation prior to completed fluorescent and
             X-ray cholangiography

          -  Allergy towards iodine, Iohexol or indocyanine green

          -  Legally incompetent (any reason)

          -  Cholangitis (as defined above)15

          -  Withdrawal of inclusion consent at any time

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT04145869

Organization ID

IFC3

Responsible Party

Principal Investigator

Study Sponsor

Hvidovre University Hospital

Collaborators

 Hillerod Hospital, Denmark

Study Sponsor

, ,

Verification Date

April 2020