Title: Bioluminescent Cholangiography
1Bioluminescent Cholangiography
2Background
- 750,000 patients undergo laparoscopic
cholecystectomy/year USA - Increased rate of common bile duct injury in
laparoscopic vs. traditional open operation well
documented - Most significant injury occurs when surgeon
misidentifies CBD as cystic duct and cuts this
structure
3Bile duct injury
4Bile duct injury
5Bile duct injury
6Bile duct injury
7- A Quick X-Ray Could Prevent Surgical Error
- BY DAVID ARMSTRONG
- Like thousands of other patients every year,
Katherine Adams learned that a commonly performed
surgery to remove the gallbladder can carry
serious risk. - The 48-year-old Illinois woman's bile duct was
severed during the operation, a mistake that
experts say happens far too often and can lead to
serious complications and death. It's also one of
the biggest causes of surgical malpractice
claims Ms. Adams herself won a judgment of more
than half a million dollars against her surgeon
and the hospital. - Now, mounting evidence suggests the hazard could
often be avoided if doctors performed a
relatively simple X-ray procedure to ...
8- A Quick X-Ray Could Prevent Surgical Error
- Doctors Split Over Procedure To Prevent Common
Injury In Gallbladder Removal . Lawrence Way, a
surgeon at the University of California San
Francisco who is an expert in repairing bile-duct
injuries, said broader use of an X-ray procedure
called an intraoperative cholangiogram that maps
out the ducts before surgery could avoid
accidental severing of the duct during surgery if
"adopted as a routine part of most surgeons'
practices." Dr. Way said the X-rays are not used
because they're expensive and hundreds of
cholangiograms would have to be performed to
avoid one bile-duct injury.
9Malpractice Insurance
10Malpractice Insurance
11Cholangiography
- Advantages
- Cholangiography is proven to lower the rate of
CBD injury - Cholangiography gives information about surgical
anatomy (and stones)
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13Cholangiography
- Disadvantages
- Time consuming and cumbersome
- Operator dependent, interpretation important
- Cost/benefit questionable as a routine procedure
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15Causes and Prevention of Laparoscopic Bile Duct
Injuries
- Analysis of 252 Cases From a Human Factors and
Cognitive Psychology Perspective - Way et al
- Ann Surg 2003
16Causes and Prevention of Laparoscopic Bile Duct
Injuries
- 97 cause of errors due to visual perceptual
illusion, faults in technical skill only 3 of
injuries - Misperception so compelling that in most cases
surgeon did not recognize a problem - There are only a few points during lap chole
where the complication causing errors occur
17Causes and Prevention of Laparoscopic Bile Duct
Injuries
- Solution 1
- Change in conduct of the operation top down
mobilization of gallbladder (haptic
perception helps guide the surgeon to the cystic
duct when it is difficult to see) - Easy to do open, not so laparoscopic
18Causes and Prevention of Laparoscopic Bile Duct
Injuries
- Solution 2
- Cholangiography is currently the most practical
technological aid for verifying the anatomy - Technology is a more likely source of help,
current practice is selective not routine use
19Causes and Prevention of Laparoscopic Bile Duct
Injuries
- We especially recommend cholangiography when
difficulties encountered - What is needed is an even simpler method of
locating the course of the ductal system during
the operation, something simpler than
cholangiography or ultrasonography
20Simple Cholangiography
- GET RID OF RADIOLOGY!
- CANNULATE THE GALLBLADDER NOT CYSTIC DUCT
- USE CHOLANGIOGRAPHY THROUGHOUT THE OPERATION
- Neff et al., BioLume
21Cholangiography
- Ideal Cholangiography
- No-radiology, no apron, no c-arm, no wait
- Simple (cholecystogram or Kumar clamp)
- Easy playback option available
- Repeatable throughout the case
22Cholangiography
- Proposal
- Develop Bioluminescent Cholangiography
23Cholangiography
- Proposal
- Develop Bioluminescent Cholangiography
- Theoretical Advantages
- Potential to meet criteria of ideal
cholangiography (simple, no radiology) - Use current laparoscopic equipment
24Bioluminescence
- Consider
- Non-heat producing light, enzymatic reaction
- Non-toxic
- Intra-abdominal cavity absolutely dark
- Used as reporter with higher sensitivity than
fluorescent dyes (less background)
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27Bioluminescent Cholangiography
- Goal Define biliary anatomy and make
cholecystectomy safer.
28Assessment of Bioluminescent Cholangiography
- A Postmortem Study of Surgical Anatomy
- Philip T Neff MD, Dept. Surgery ELMC, Bruce
Bryan MD, BioLume, Randall B. Murphy PhD BioLume - Approved Exempla IRB 200708
29Assessment of Bioluminescent Cholangiography
- Autopsy study using bioluminescent
cholangiography and video-cameras and
laparoscopic equipment
30Assessment of Bioluminescent Cholangiography
- Autopsy study using bioluminescent
cholangiography and video-cameras and
laparoscopic equipment - At time of open autopsy perform bioluminescent
cholangiography and video record
31Assessment of Bioluminescent Cholangiography
- LABORATORY MODELS
- Human Cadaver open with video-camera
- Human Cadaver with laparoscopy
- Pig Lab with laparoscopy
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33Bioluminescent Cholangiography
- Bioluminescence can be used with many types of
laparoscopes - The equipment will have to be modified optimized
for bioluminescence
34Bioluminescent Cholangiography
- Convergence of technology, bioluminescence and
laparoscopy - Public demands safety
- Malpractice companies request safety
- Surgical literature suggests that technological
advances will solve problem (but does not state
how!)
35Bioluminescent Cholangiography
- Future Clinical Studies
- Phase I study, assess toxicity (non-toxic)
- Phase II and III clinical human trials compare
bioluminescent cholangiography with standard IOC