Bioluminescent Cholangiography

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Bioluminescent Cholangiography

• Enhancing Patient Safety

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Background

• 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

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Bile duct injury

• Strasberg Classification

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Bile duct injury

• Strasberg Classification

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Bile duct injury

• Strasberg Classification

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Bile duct injury

• Strasberg Classification

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• 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 ...

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• 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.

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Malpractice Insurance
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Malpractice Insurance
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Cholangiography

• Advantages
• Cholangiography is proven to lower the rate of
  CBD injury
• Cholangiography gives information about surgical
  anatomy (and stones)

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Cholangiography

• Disadvantages
• Time consuming and cumbersome
• Operator dependent, interpretation important
• Cost/benefit questionable as a routine procedure

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Causes 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

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Causes 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

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Causes 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

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Causes 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

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Causes 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

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Simple Cholangiography

• GET RID OF RADIOLOGY!
• CANNULATE THE GALLBLADDER NOT CYSTIC DUCT
• USE CHOLANGIOGRAPHY THROUGHOUT THE OPERATION
• Neff et al., BioLume

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Cholangiography

• Ideal Cholangiography
• No-radiology, no apron, no c-arm, no wait
• Simple (cholecystogram or Kumar clamp)
• Easy playback option available
• Repeatable throughout the case

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Cholangiography

• Proposal
• Develop Bioluminescent Cholangiography

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Cholangiography

• Proposal
• Develop Bioluminescent Cholangiography
• Theoretical Advantages
• Potential to meet criteria of ideal
  cholangiography (simple, no radiology)
• Use current laparoscopic equipment

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Bioluminescence

• 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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Bioluminescent Cholangiography

• Goal Define biliary anatomy and make
  cholecystectomy safer.

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Assessment 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

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Assessment of Bioluminescent Cholangiography

• Autopsy study using bioluminescent
  cholangiography and video-cameras and
  laparoscopic equipment

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Assessment 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

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Assessment of Bioluminescent Cholangiography

• LABORATORY MODELS
• Human Cadaver open with video-camera
• Human Cadaver with laparoscopy
• Pig Lab with laparoscopy

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Bioluminescent Cholangiography

• Bioluminescence can be used with many types of
  laparoscopes
• The equipment will have to be modified optimized
  for bioluminescence

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Bioluminescent 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!)

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Bioluminescent Cholangiography

• Future Clinical Studies
• Phase I study, assess toxicity (non-toxic)
• Phase II and III clinical human trials compare
  bioluminescent cholangiography with standard IOC