Fluorescent Cholangiography During Acute Cholecystitis

Hvidovre University Hospital

Status: Withdrawn

Conditions: Acute Cholecystitis

Treatments: Procedure: Cholangiography

Study type: Interventional

Funder types: Other

Identifiers

NCT04145869

IFC3

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Fluorescent cholangiography

Experimental group

Description:

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

Treatment:

Procedure: Cholangiography

X-ray cholangiography

Active Comparator group

Description:

Intraoperative X-ray cholangiography using an intraductal (cystic duct) injection of Iohexol

Treatment:

Procedure: Cholangiography