Laparoscopic Cholecystectomy

SPY IMAGING IN Laparoscopic Cholecystectomy

Each year in the United States, over 750,000 patients undergo laparoscopic gall bladder surgery also known as cholecystectomy, making it the most frequently performed abdominal surgery. Although the complication rates in cholecystectomy are low, when they do occur they can be quite critical. Massarweh and Flum reported that common bile duct (CBD) injury during cholecystectomy occurs with relative infrequency (1 in 200 to 400), but ranks among the leading sources of medical malpractice claims. Between 34% and 49% of surgeons are expected to cause such an injury during their career.

Repair of CBD is often complex, requires multiple procedures and has a substantial impact on quality of life, functional status and survival. Bile duct injury rates have increased since the introduction of laparoscopic cholecystectomy, occurring in about 3 per 1,000 procedures performed and bile duct injuries after cholecystectomy can be life altering complications leading to significant morbidity and cost.2  Podnos and fellow researchers at the University of California Irvine reported that in a retrospective review of patients referred for the management of bile duct injury over a four year period, patients with bile duct injuries incurred median hospital stays of 11.5 days at an average cost of $587,491. The average cost of those requiring reoperation was $669,134.

These facts led the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) to develop the Safe Cholecystectomy Program– Strategies for Minimizing Bile Duct Injuries: Adopting a Universal Culture of Safety in Cholecystectomy. NOVADAQ supports the SAGES initiative and as a corporate benefactor to the SAGES Foundation provides grants to support medical education and research to further the aims of the program. Based on the experiences of leading surgeons throughout the world and the published medical literature, PINPOINT can potentially contribute to a safer laparoscopic cholecystectomy for patients.

Highlights from the medical literature supporting the use of PINPOINT in laparoscopic cholecystectomy include, a case study in which the PINPOINT system was used to identify anomalous biliary anatomy during laparoscopic cholecystectomy in a 28-year-old female with a history of biliary colic and evidence of cholelithiasis was reported by Sherwinter. Anomalous biliary anatomy is common in up to 23% of patients. Intraoperative cholangiogram can be helpful in identifying anatomy, but radiation exposure, prolonged operative times and the potential for organ damage have led to its dwindling use. Sherwinter reported that PINPOINT provided similar anatomical detail without the previously described concerns.

In a recent study of 37 patients, Zarrinpar and colleagues at University of California Los Angeles similarly concluded that the dosage and timing of administration of ICG prior to intraoperative visualization [of hepatic, biliary and cystic ducts] are within a range where it can be administered in a practical, safe, and effective manner to allow intraoperative identification of extrahepatic biliary anatomy using NIRFC (PINPOINT).

Clinical References

1. Massarweh N and Flum D. Role of Intraoperative Cholangiography in Avoiding Bile Duct Injury. Journal Amer College of Surgeons, April 2007. Vol. 201, No. 4: 656-664

2. http://www.sages.org/safe-cholecystectomy-program/ 2016 Society of American Gastrointestinal and Endoscopic Surgeons

3. Podnos, et al., Is Intraoperative Cholangiography During Laparoscopic Cholecystectomy Cost Effective? Am J Surg

4. Sherwinter DA. Identification of Anomolous Biliary Anatomy Using Near-Infrared Cholangiography. J Gastrointest Surg. 2012 Jul 3. [Epub ahead of print] PubMed PMID: 22752550.

5. Zarrinpar A, Dutson EP, Mobley C, Busuttil RW, Lewis CE, Tillou A, Cheaito A, Hines OJ, Agopian VG, Hiyama DT. Intraoperative Laparoscopic Near-Infrared Fluorescence Cholangiography to Facilitate Anatomical Identification: When to Give Indocyanine Green and How Much. Surgical Innovation. 2016.