Promising Initial Experience With Intra-operative Fluorescent Cholangiography

• Sponsor: Hvidovre University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02136095
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 11.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gall Stone Disease	Procedure: Intraoperative fluorescent cholangiography (IFC)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Promising Initial Experience With Intra-operative Fluorescent Cholangiography
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Procedure: Intraoperative fluorescent cholangiography (IFC); A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy.

Outcome Measures

Primary Outcome Measures

1. Time expenditure of IFC with concomitant angiography. [Four months]

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

Secondary Outcome Measures

1. Success-rate of the IFC-procedures. [Four months]

   The operating surgeon completed a structured questionnaire immediately after each operation regarding anatomical identification by IFC (visible cystic duct, -common bile duct, -common hepatic duct, -right and left hepatic ducts, -cystic artery, -aberrant bile ducts, and/or other abnormalities). Successful IFC was defined as exposure of the junction between the cystic duct, common bile duct and common hepatic duct by IFC. Success-full fluorescent angiography was defined as adequate visualisation of the cystic artery within Calot´s triangle by the method.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hvidovre University Hospital	Hvidovre		Denmark	DK-2650

Sponsors and Collaborators

• Hvidovre University Hospital

Investigators

• Principal Investigator: Søren Larsen, MD, PhD, Gastroenheden, Hvidovre University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Søren S. Larsen, MD, PhD, Hvidovre University Hospital
• ClinicalTrials.gov Identifier: NCT02136095
• Other Study ID Numbers: IFC_Feasibility_study
• First Posted: May 12, 2014
• Last Update Posted: May 12, 2014
• Last Verified: May 1, 2014

• Keywords provided by Søren S. Larsen, MD, PhD, Hvidovre University Hospital: Fluorescent cholangiography; Laparoscopic cholecystectomy
• Additional relevant MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis

Study Results

No Results Posted as of May 12, 2014