Fluorescent Cholangiography and Bile Duct Stones

Sensitivity and Specificity of Fluorescent Cholangiography to Detect Bile Duct Stones in Patients Undergoing Laparoscopic Cholecystectomy

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03530241

Enrollment

Registered

2018-05-21

Start date

2019-03-25

Completion date

2023-08-01

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gall Stones, Common Bile Duct

Keywords

fluorescence, cholangiography, cholecystectomy, laparoscopic

Brief summary

Background. X-ray cholangiography has a high sensitivity and specificity of detecting bile duct stones and is the gold standard. There are no studies describing the sensitivity and specificity of IFC for bile duct stone detection. Research question. What is the sensitivity of IFC to visualize bile duct stones? Method. Prospective study with 40 patients undergoing planned laparoscopic cholecystectomy with preoperative magnetic resonance cholangiopancreatography (MRCP) (gold standard) and intraoperative IFC, X-ray cholangiography and choledochuscopy in that order. Primary outcome. Sensitivity of visualization of bile duct stone by fluorescent cholangiography and secondary outcome is visualization of anatomy.

Interventions

DIAGNOSTIC_TESTPresence of bile duct stones

MRCP verified gall stones in the bile ducts

DIAGNOSTIC_TESTNon-presence of bile duct stones

MRCP without bile duct stones

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients suspected of having bile duct stones by either blood samples, MRCP or medical history (see definitions) * Patient age ≥ 18 years * Preoperative MRCP * Operation performed by a project surgeon

Exclusion criteria

* Open cholecystectomy (including conversion from laparoscopic to open) * Acute cholecytitis or cholangitis * Pancreatitis * Iodine or indocyanine green allergy * Liver or renal insufficiency * Thyrotoxicosis * Cholecystectomy not the primary surgical procedure * Pregnancy or lactation * Legally incompetent for any reason * Withdrawal of inclusion consent at any time

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity	120mins	Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography

Secondary

Measure	Time frame	Description
Visualization	120mins	Visualization of the extrahepatic bile ducts

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026