Fluorescence Cholangiography During Cholecystectomy

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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2018-08-27

Brief Summary

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The primary objective is to compare the success rates of intraoperative fluorescent cholangiography using indocyanine green versus conventional X-ray cholangiography for the identification of bile duct anatomy during laparoscopic cholecystectomy for complicated gallstone disease in a randomized design with 120 patients.

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Detailed Description

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Conditions

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Cholecystitis Gallstones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Fluorescence cholangiography

After induction of anaesthesia 2.5-7.5 mg of indocyanine green (0.05 mg/kg) is injected intravenously. The operation field is routinely inspected in the fluorescence imaging mode before dissection of Calot´s triangle. During dissection, the fluorescence imaging mode is used when needed, before division of any tubular structure and after division of the cystic duct and artery.

Group Type EXPERIMENTAL

Indocyanine green

Intervention Type DRUG

Near-infrared illumination

Intervention Type DEVICE

To see the fluorescence from indocyanine green

X-ray cholangiography

The cholangiography is performed after dissection of the cystic duct by cannulation of the cystic duct with a catheter using either a Kumar- or Olsen grasper. A mobile X-ray C-arm system is used, and the monochrome X-ray image is shown on a separate screen. After satisfactory identification of the extra-hepatic biliary ducts, the intraoperative cholangiography is discontinued and the gallbladder is removed in a standardized manner.

Group Type ACTIVE_COMPARATOR

Urografin

Intervention Type DRUG

X-ray

Intervention Type RADIATION

Interventions

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Indocyanine green

Intervention Type DRUG

Near-infrared illumination

To see the fluorescence from indocyanine green

Intervention Type DEVICE

Urografin

Intervention Type DRUG

X-ray

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Patient scheduled for planned laparoscopic cholecystectomy by one surgeon
* Complicated gallstone disease

Exclusion Criteria

* Open cholecystectomy
* Allergy towards iodine, urografin or indocyanine green
* Liver or renal insufficiency
* Thyrotoxicosis
* Pregnancy or lactation
* Legally incompetent for any reason
* Withdrawal of inclusion consent at any time

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No