A Pilot Dosing and Timing Study to Optimize Imaging When Utilizing Endoscopic Fluorescence Imaging System During Laparoscopic Biliary and Hepatic Operations
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/7/2015 |
| Start Date: | January 2014 |
| Contact: | Ali Zarrinpar, MD PhD |
| Phone: | 310-825-1037 |
A Pilot Study to Optimize Imaging When Utilizing the PINPOINT Endoscopic Fluorescence Imaging System for Identification of Biliary Anatomy During Laparoscopic Biliary and Hepatic Operations
Operations on the liver, bile ducts, and gallbladders are some of the most commonly
performed abdominal operations in the United States. Cholecystectomy, removal of the
gallbladder, is the most common of these with more than 750,000 performed annually. Injury
to the common bile duct (CBD) during these procedures occur infrequently (approximately 0.1%
to 0.5%), but it is an important source of patient morbidity. Serious injuries often require
at least one surgical repair, and these repairs have variable long-term outcomes. Techniques
to allow the visualization of the bile ducts may prevent such an injury, by providing vital
information about the presence of gallstones in the CBD and show a surgical road map of the
ducts. Near-infrared (NIR) cholangiography has the advantage over standard cholangiography
of not exposing patients and healthcare providers to radiation. This technique also allows
the superimposition of the cholangiogram onto the normal image.
This study is being conducted to optimize an imaging technique called PINPOINT. Images will
be obtained during clinically necessary operations. The images will be evaluated to
determine the best method for locating and outlining the anatomy. The information learned
will guide the future use of PINPOINT in laparoscopic procedures.
performed abdominal operations in the United States. Cholecystectomy, removal of the
gallbladder, is the most common of these with more than 750,000 performed annually. Injury
to the common bile duct (CBD) during these procedures occur infrequently (approximately 0.1%
to 0.5%), but it is an important source of patient morbidity. Serious injuries often require
at least one surgical repair, and these repairs have variable long-term outcomes. Techniques
to allow the visualization of the bile ducts may prevent such an injury, by providing vital
information about the presence of gallstones in the CBD and show a surgical road map of the
ducts. Near-infrared (NIR) cholangiography has the advantage over standard cholangiography
of not exposing patients and healthcare providers to radiation. This technique also allows
the superimposition of the cholangiogram onto the normal image.
This study is being conducted to optimize an imaging technique called PINPOINT. Images will
be obtained during clinically necessary operations. The images will be evaluated to
determine the best method for locating and outlining the anatomy. The information learned
will guide the future use of PINPOINT in laparoscopic procedures.
Inclusion Criteria:
To be eligible for the study, subjects must fulfill all of the following criteria:
1. Subjects who are healthy men or women 18 years of age or older.
2. Subjects who are scheduled for laparoscopic biliary or hepatic operations.
3. Subjects who sign an approved informed consent form for the study.
4. Subjects who are willing to comply with the protocol.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
1. Subjects with a known allergy or history of adverse reaction to ICG, iodine or iodine
dyes.
2. Subjects who, in the Investigator's opinion, have any medical condition that makes
the subject a poor candidate for the investigational procedure, or interferes with
the interpretation of study results.
3. Subjects who are pregnant or lactating females.
4. Subjects, who are actively participating in another investigational clinical study
and who, in the Investigator's or Sponsor's opinion, should not be enrolled in this
study.
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