Fluorescence Cholangiography During Cholecystectomy - a RCT

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02344654

Collaborator

(none)

120

Enrollment

Arms

39.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cholecystitis Gallstones	Drug: Indocyanine green Device: Near-infrared illumination Drug: Urografin Radiation: X-ray	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Fluorescence Cholangiography Versus X-ray Cholangiography During Laparoscopic Cholecystectomy for Complicated Gallstone Disease

Actual Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Aug 27, 2018

Actual Study Completion Date :

Aug 27, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Indocyanine green Device: Near-infrared illumination To see the fluorescence from indocyanine green
Active Comparator: 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.	Drug: Urografin Radiation: X-ray

Arm

Intervention/Treatment

Experimental: 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.

Drug: Indocyanine green

Device: Near-infrared illumination

To see the fluorescence from indocyanine green

Active Comparator: 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.

Drug: Urografin

Radiation: X-ray

Outcome Measures

Primary Outcome Measures

Visualization of the cystic duct - common hepatic duct - common bile duct junction [Intraoperative]

Secondary Outcome Measures

Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography [Intraoperative]
Surgeon satisfaction score (Measured on a 5 point VAS scale) [Intraoperative]
Measured on a 5 point VAS scale
Per-/postoperative adverse events as a measure of safety and tolerability [Intraoperative]
Total cost of operation incl fluorescent/conventional X-ray cholangiography [Admission to discharge from hospital (0-30 days)]