Fluorescent Cholangiography and Bile Duct Stones

NCT03530241 | Withdrawn DMC

• 1 other identifier: IFC4
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gall Stones, Common Bile Duct

Keywords

fluorescence; cholangiography; cholecystectomy, laparoscopic

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity

  Sensitivity and specificity of visualization of bile duct stones by intraoperative fluorescent cholangiography

  120mins

Secondary Outcomes (1)

• Visualization

  120mins

Study Arms (2)

MRCP positive

EXPERIMENTAL

Diagnostic Test: Presence of bile duct stones

MRCP negative

ACTIVE COMPARATOR

Diagnostic Test: Non-presence of bile duct stones

Interventions

Presence of bile duct stones DIAGNOSTIC_TEST

MRCP verified gall stones in the bile ducts

MRCP positive

Non-presence of bile duct stones DIAGNOSTIC_TEST

MRCP without bile duct stones

MRCP negative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Holte, Danmark, 2840, Denmark

Location

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars L Lehrskov, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: March 25, 2019
• Primary Completion: October 31, 2020
• Study Completion: August 1, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

DK (1)