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

Sponsor

Intuitive Surgical (Industry)

Overall Status

Completed

CT.gov ID

NCT01410734

Collaborator

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria (Other), University Hospital, Geneva (Other)

Enrollment

Locations

Arm

17.1

Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gallbladder Disease Biliary Colic Gallstones	Drug: Indocyanine green (ICG)	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Indocyanine green (ICG) 2.5mg indocyanine green (ICG) will be administerly (IV injection) 30 minutes before surgery

Arm

Intervention/Treatment

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.

Drug: Indocyanine green (ICG)

2.5mg indocyanine green (ICG) will be administerly (IV injection) 30 minutes before surgery

Outcome Measures

Primary Outcome Measures

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). [intra-operatively]

Secondary Outcome Measures

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) [within 2 weeks post-operatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SS Antonio e Biagio e Cesare Arrigo	Alessandria	AL	Italy	15100
2	Hospital University Geneva	Geneva		Switzerland

Sponsors and Collaborators

Intuitive Surgical
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Intuitive Surgical

ClinicalTrials.gov Identifier:

NCT01410734

Other Study ID Numbers:

Fluorescence Bliliary ID

First Posted:

Aug 5, 2011

Last Update Posted:

Dec 20, 2012

Last Verified:

Dec 1, 2012

Keywords provided by Intuitive Surgical

cholecystectomy

chronic right upper quadrant pain

Additional relevant MeSH terms:

Gallstones

Gallbladder Diseases

Study Results

No Results Posted as of Dec 20, 2012