Promising Initial Experience With Intra-operative Fluorescent Cholangiography

Hvidovre University Hospital35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gall Stone Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: Four months

Secondary Outcomes

Success-rate of the IFC-procedures.

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.