Fluorescent Cholangiography and Bile Duct Stones

Hvidovre University Hospital

Status: Withdrawn

Conditions: Gall Stones, Common Bile Duct

Treatments: Diagnostic Test: Presence of bile duct stones; Diagnostic Test: Non-presence of bile duct stones

Study type: Interventional

Funder types: Other

Identifiers

NCT03530241

IFC4

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

MRCP positive

Experimental group

Treatment:

Diagnostic Test: Presence of bile duct stones

MRCP negative

Active Comparator group

Treatment:

Diagnostic Test: Non-presence of bile duct stones