Fluorescence Cholangiography During Cholecystectomy - a RCT

Hvidovre University Hospital

Status: Completed

Conditions: Cholecystitis; Gallstones

Treatments: Radiation: X-ray; Drug: Urografin; Device: Near-infrared illumination; Drug: Indocyanine green

Study type: Interventional

Funder types: Other

Identifiers

NCT02344654

2015-HVH-LLS-01

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

Fluorescence cholangiography

Experimental group

Description:

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.

Treatment:

Device: Near-infrared illumination

Drug: Indocyanine green

X-ray cholangiography

Active Comparator group

Description:

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.

Treatment:

Drug: Urografin

Radiation: X-ray