WithdrawnNot Applicable

Fluorescent Cholangiography and Bile Duct Stones

Stopped: No funding

Denmark0Started 2019-03-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Sensitivity and specificity

Timeframe: 120mins

Trial details

NCT IDNCT03530241

SponsorHvidovre University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-31

View on ClinicalTrials.gov More Gall Stones, Common Bile Duct trials