Fluorescent Cholangiography During Acute Cholecystitis

NCT ID: NCT04145869

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2025-03-01

Brief Summary

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

Detailed Description

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Conditions

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Acute Cholecystitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fluorescent cholangiography

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

Group Type EXPERIMENTAL

Cholangiography

Intervention Type PROCEDURE

All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography

X-ray cholangiography

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

Group Type ACTIVE_COMPARATOR

Cholangiography

Intervention Type PROCEDURE

All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography

Interventions

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Cholangiography

All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillerod Hospital, Denmark

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars Lang Lehrskov

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northzealand Hospiral Hillerød

Hillerød, Danmark, Denmark

Site Status

Hvidovre University Hospital

Hvidovre, Danmark, Denmark

Site Status

Zealand University Hospital Køge

Køge, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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IFC3

Identifier Type: -

Identifier Source: org_study_id

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