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

Not Applicable

Completed

• Conditions: Gallbladder Disease; Biliary Colic; Gallstones
• Interventions: Drug: Indocyanine green (ICG)

• Registration Number: NCT01410734
• Lead Sponsor: Intuitive Surgical

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.

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Status Verified: 2012-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICG	Indocyanine green (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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Hospital University Geneva; 🇨🇭 Geneva, Switzerland

SS Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, AL, Italy