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Bioluminescent Cholangiography. “ Enhancing Patient Safety”. Background. 750,000 patients undergo laparoscopic cholecystectomy/year USA Increased rate of common bile duct injury in laparoscopic vs. traditional open operation well documented

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bioluminescent cholangiography
Bioluminescent Cholangiography

“ Enhancing Patient Safety”

background
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
bile duct injury
Bile duct injury

Strasberg Classification

bile duct injury4
Bile duct injury

Strasberg Classification

bile duct injury5
Bile duct injury

Strasberg Classification

bile duct injury6
Bile duct injury

Strasberg Classification

slide7
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 ...

slide8
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.

cholangiography
Cholangiography

Advantages

  • Cholangiography is proven to lower the rate of CBD injury
  • Cholangiography gives information about surgical anatomy (and stones)
cholangiography13
Cholangiography

Disadvantages

  • Time consuming and cumbersome
  • Operator dependent, interpretation important
  • Cost/benefit questionable as a routine procedure
causes and prevention of laparoscopic bile duct injuries
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

causes and prevention of laparoscopic bile duct injuries16
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
causes and prevention of laparoscopic bile duct injuries17
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
causes and prevention of laparoscopic bile duct injuries18
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
causes and prevention of laparoscopic bile duct injuries19
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”

simple cholangiography
Simple Cholangiography
  • GET RID OF RADIOLOGY!
  • CANNULATE THE GALLBLADDER NOT CYSTIC DUCT
  • USE CHOLANGIOGRAPHY THROUGHOUT THE OPERATION

Neff et al., BioLume

cholangiography21
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
cholangiography22
Cholangiography

Proposal:

Develop Bioluminescent Cholangiography

cholangiography23
Cholangiography

Proposal:

Develop Bioluminescent Cholangiography

Theoretical Advantages

  • Potential to meet criteria of ideal cholangiography (simple, no radiology)
  • Use current laparoscopic equipment
bioluminescence
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)
bioluminescent cholangiography27
Bioluminescent Cholangiography

Goal:Define biliary anatomy and make cholecystectomy safer.

assessment of bioluminescent cholangiography
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

assessment of bioluminescent cholangiography29
Assessment of Bioluminescent Cholangiography:
  • Autopsy study using bioluminescent cholangiography and video-cameras and laparoscopic equipment
assessment of bioluminescent cholangiography30
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
assessment of bioluminescent cholangiography31
Assessment of Bioluminescent Cholangiography:

LABORATORY MODELS

  • Human Cadaver open with video-camera
  • Human Cadaver with laparoscopy
  • Pig Lab with laparoscopy
bioluminescent cholangiography33
Bioluminescent Cholangiography
  • Bioluminescence– can be used with many types of laparoscopes
  • The equipment will have to be modified optimized for bioluminescence
bioluminescent cholangiography34
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!)
bioluminescent cholangiography35
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