Promising Initial Experience With Intra-operative Fluorescent Cholangiography

NCT ID: NCT02136095

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

IFC-group

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.

Group Type: EXPERIMENTAL

Intraoperative fluorescent cholangiography (IFC)

Intervention Type: PROCEDURE

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

Interventions

Intraoperative fluorescent cholangiography (IFC)

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Søren S. Larsen

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Søren Larsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Gastroenheden, Hvidovre University Hospital

Locations

Hvidovre University Hospital

Hvidovre, Hvidovre, Denmark

Countries

Denmark

References

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

Reference Type: DERIVED

PMID: 25162446 (View on PubMed)

Other Identifiers

IFC_Feasibility_study

Identifier Type: -

Identifier Source: org_study_id