Early Experience with Transgastric NOTES Cholecystectomy in Humans

Natural orifice transluminal endoscopic surgery has enjoyed an accelerated development, going from theory to clinical application in less than 4 years. Early concepts of NOTES procedures seldom included cholecystectomy as it was considered too complex and challenging to approach with current technology. An unprecedented evolution of flexible endoscopes and endoscopic tools changed this and currently cholecystectomy is the most commonly reported human case worldwide. To date, NOTES cholecystectomy has been done via a transvaginal approach in small numbers with apparently good results. For several reasons we prefer the transgastric approach, particularly for male patients. We report our early experience with hybrid transgastric NOTES performed at 2 collaborating institutions.

Methods: Four patients, (3F/1M) with symptomatic cholelithiasis by standard evaluation participated in an IRB approved NOTES study. By study protocol a minimum of 1 laparoscopic port was required to ensure procedure safety and to check the integrity of the endoluminal gastric closure. Additional ports were recommended as needed for safety and efficiency. The Transport (USGI Medical) endoscopic operating system (EOS) was used for all cases. Cases were done in the OR under general anesthesia. Gastrotomy, gallbladder dissection, per oral extraction and gastrotomy closure were performed with the flexible endoscope and endoscopic instruments. Outcomes measurements included: OR results, HRQOL, pain scoring and clinical outcomes.

Results: Mean operative time was 4.2 hours (3.5 – 5), numbers of laparoscopic ports (2 or 5 mm) used ranged from 1 to 3. Operative time was inversely related to the number of ports. EBL was 66 ml (5 – 200). There were no intraoperative complications and all gastrotomies were confirmed intact by methelyne blue gastric infusion or insufflation. Mean analog pain scores were 2.9/10, 2.5/10, 0/10 respectively, in Recovery, POD 1 and POD 14. Pain was primarily laparoscopic port related. Maximal pain was in the RUQ in 2, epigastric in 1 and pharyngeal in 1. There were no late complications.

Conclusion: Initial experience with human transgastric NOTES cholecystectomy show it to be feasible and safe with current advanced endoscopic instrumentation. Patients tolerated it well and may have had less pain than with a laparoscopic gallbladder surgery. NOTES chole is a complex and demanding procedure requiring advanced endoscopic surgical skills and mastery of flexible endoscopy.


Session: Podium Presentation

Program Number: S034

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