Promising Initial Experience With Intra-operative Fluorescent Cholangiography

NCT02136095 | Completed

• 1 other identifier: IFC_Feasibility_study
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is a recently developed method for non-invasive visualisation of the relevant anatomy during laparoscopic cholecystectomy. The objective of this study was to assess the time required by routine-use of IFC and to evaluate success-rate of the procedures. Methods Thirty-five patients scheduled for laparoscopic cholecystectomy and operated by the same surgeon were consecutively enrolled. A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy. Intra-operative time-registration and exposure of predefined anatomical structures were recorded.

Conditions

Gall Stone Disease

Keywords

Fluorescent cholangiography; Laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Time expenditure of IFC with concomitant angiography.

  Intra-operative fluorescent-imaging-mode-time was registered by a study-nurse during the operations (performed between september and december 2013)

  Four months

Secondary Outcomes (1)

• Success-rate of the IFC-procedures.

  Four months

Study Arms (1)

IFC-group

EXPERIMENTAL

The investigators included patients undergoing laparoscopic cholecystectomy by a single surgeon between September and December 2013 at a single centre university department with unrestricted referral of patients. The included patients represented all patients undergoing laparoscopic cholecystectomy by one surgeon during the study period. All patients underwent intra-operative fluorescent cholangiography (IFC) with concomitant angiography, according to a standardized protocol, during their laparoscopic cholecystectomy.

Procedure: Intraoperative fluorescent cholangiography (IFC)

Interventions

Intraoperative fluorescent cholangiography (IFC) PROCEDURE

A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy.

IFC-group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Scheduled for acute- or elective laparoscopic cholecystectomy
• Informed consent

You may not qualify if:

• Known iodine-hypersensitivity
• Liver- or renal insufficiency
• Known thyrotoxicosis
• Pregnancy or lactation

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Hvidovre, DK-2650, Denmark

Location

Related Publications (1)

• Larsen SS, Schulze S, Bisgaard T. Non-radiographic intraoperative fluorescent cholangiography is feasible. Dan Med J. 2014 Aug;61(8):A4891.

  PMID: 25162446 DERIVED

Study Officials

• Søren Larsen, MD, PhD

  Gastroenheden, Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 12, 2014
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

DK (1)