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Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)

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ClinicalTrials.gov Identifier: NCT01410734
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : December 20, 2012
Sponsor:
Collaborators:
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
University Hospital, Geneva
Information provided by (Responsible Party):
Intuitive Surgical

August 3, 2011
August 5, 2011
December 20, 2012
July 2011
December 2012   (Final data collection date for primary outcome measure)
To identify biliary anatomy will be demonstrated by successful detection (90%) of one or more of the following biliary vessels: Cystic duct, common hepatic duct (CHD) or common bile duct (CBD). [ Time Frame: intra-operatively ]
Same as current
Complete list of historical versions of study NCT01410734 on ClinicalTrials.gov Archive Site
observe and report peri-operative safety outcomes, including but not limited to incidence of adverse events and allergic reactions (rare according to the current knowledge and applications) [ Time Frame: within 2 weeks post-operatively ]
Same as current
Not Provided
Not Provided
 
Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)
A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree
The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as identifying biliary vessels; either cystic duct, common hepatic duct (CHD) or common bile duct (CBD). Irradiation given to the patient during a classic cholangiography can be reduced.

Up to 40 patients will be prospectively enrolled in this multi-centre (up to 5 centres) single arm study. After given consent, patients will undergo minimally invasive cholecystectomy with da Vinci Fluorescence Imaging using Indocynine green (ICG) and near infra-red light (NIR) to identify the surgically relevant anatomy of the biliary tree during this procedure.

Efficacy endpoints The efficacy of the da Vinci Fluorescence Imaging Vision System to identify biliary anatomy will be demonstrated by successful detection (90%) of one or more of the following biliary vessels: Cystic duct, common hepatic duct (CHD) or common bile duct (CBD).

Safety endpoints To observe and report peri-operative safety outcomes, including but not limited to incidence of adverse events and allergic reactions (rare according to the current knowledge and applications). Safety endpoints will be met by affirming the safety profile of the procedure, compared to currently available literature.

Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Gallbladder Disease
  • Biliary Colic
  • Gallstones
Drug: Indocyanine green (ICG)
2.5mg indocyanine green (ICG) will be administerly (IV injection) 30 minutes before surgery
Experimental: ICG
Patient will received IV injection of ICG intra-operatively. Surgeon will view bile ducts under fluorescence imaging mode to see if ICG helps to identify biliary ducts.
Intervention: Drug: Indocyanine green (ICG)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
40
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Informed consent
  • Ages of 18 to 80 years.
  • Symptoms consistent with gallbladder disease including biliary colic or chronic right upper quadrant pain.
  • Ultrasound confirming gallstones

Exclusion Criteria:

  • Acute cholecystitis
  • Biliary pancreatitis
  • Suspicion of common bile duct stones.
  • Pregnancy.
  • Previous upper abdominal open surgeries.
  • Severe lack of cooperation by patient due to psychological or severe systemic illness.
  • The presence of medical conditions contraindicating general anesthesia or standard surgical approaches.
  • Subject has a previous history of adverse reaction or allergy to ICG, iodine products (or excipient), shellfish or iodine dyes
  • Surgery converted to non-robotic procedures, such as open surgery or laparoscopic surgery
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy,   Switzerland
 
 
NCT01410734
Fluorescence Bliliary ID
Yes
Not Provided
Not Provided
Intuitive Surgical
Intuitive Surgical
  • Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
  • University Hospital, Geneva
Not Provided
Intuitive Surgical
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP