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

Gallstones Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410734
• Other study ID #: Fluorescence Bliliary ID
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: December 19, 2012
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2012
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Biliary Colic
• Gallbladder Disease
• Gallbladder Diseases
• Gallstones

Intervention

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

Locations

Country	Name	City	State
Italy	SS Antonio e Biagio e Cesare Arrigo	Alessandria	AL
Switzerland	Hospital University Geneva	Geneva

Sponsors (3)

Lead Sponsor	Collaborator
Intuitive Surgical	Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo, University Hospital, Geneva

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes