Fluorescence Cholangiography During Cholecystectomy - a RCT

Hvidovre University Hospital120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

120

Conditions

Cholecystitis Gallstones

Interventions

Indocyanine greenDRUG

Near-infrared illuminationDEVICE

To see the fluorescence from indocyanine green

UrografinDRUG

X-rayRADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Visualization of the cystic duct - common hepatic duct - common bile duct junction

Time frame: Intraoperative

Secondary Outcomes

Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography

Time frame: Intraoperative

Surgeon satisfaction score (Measured on a 5 point VAS scale)

Measured on a 5 point VAS scale

Time frame: Intraoperative

Per-/postoperative adverse events as a measure of safety and tolerability

Time frame: Intraoperative

Total cost of operation incl fluorescent/conventional X-ray cholangiography

Time frame: Admission to discharge from hospital (0-30 days)

Data from ClinicalTrials.gov

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