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NCT02344654 Clinical Trial

Fluorescence Cholangiography During Cholecystectomy - a RCT

Cholecystitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02344654
Other study ID # 2015-HVH-LLS-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2015
Est. completion date August 27, 2018

Study information
Verified date February 2024
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date August 27, 2018
Est. primary completion date August 27, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Indocyanine green

Device:
• Near-infrared illumination
To see the fluorescence from indocyanine green
Drug:
• Urografin

Radiation:
• X-ray

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

References & Publications (1)

Lehrskov LL, Westen M, Larsen SS, Jensen AB, Kristensen BB, Bisgaard T. Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial. Br J Surg. 2020 May;107(6):655-661. doi: 10.1002/bjs.11510. Epub 2020 Feb — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Visualization of the cystic duct - common hepatic duct - common bile duct junction Intraoperative
Secondary Time spend for intraoperative fluorescent cholangiography/conventional X-ray cholangiography Intraoperative
Secondary Surgeon satisfaction score (Measured on a 5 point VAS scale) Measured on a 5 point VAS scale Intraoperative
Secondary Per-/postoperative adverse events as a measure of safety and tolerability Intraoperative
Secondary Total cost of operation incl fluorescent/conventional X-ray cholangiography Admission to discharge from hospital (0-30 days)
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