1. 2010 NOTES ® Summit Working Group Report Transgastric cholecystectomy July 8-10, 2010 Chicago, IL

2. Published cases: Zorron et al 2010 – 29 hybrid (Salinas et al – 27 cases hybrid): Endoscopic or laparoscopic dissection Operator: Surgeon predominance Access – lap visualization, sphincterotome, balloon dilation Laparoscopic closure of gastrotomy with 2 or 3 trocars (3 or 5mm) OR time: 111 min, anesthesia time 154, complications 24%, LOS 1.5 days 3 conversions to lap: epiploic bleeding, stone extraction Dallemagne et al – 10 hybrid Pre-op antibiotics (Ancef 2g) and lovenox (40U) Endoscopic and laparoscopic dissection Operator : Surgeon Access : lap visualization, needle knife, balloon 4/10 with extra 2mm trocar Lap closure of gastrotomy using 2mm scope and 3mm needle driver side by side through umbilical incision OR time 150 minutes No major complication Other known cases: Swanstrom (Legacy) – 12, Hungness (Northwestern) – 4, Horgan (UCSD) -8 (6 Argentina, 2 US), Neto – 16 (Brazil), Perretta – 1 additional

3. Initial questions/statements: Are there any true advantages of TG chole over lap chole? Should we be doing this at all? Published complication rates too high – mainly related to extraction of large GB. Esophageal perforation and mediastinitis – convert to lap; thoracic drainage Esophageal hematoma and laceration (2 patients) Gastric access bleeding (epiploic vessels) – convert to open Umbilical wound infection Peritonitis (Strep faecalis, no gastric leak) – lap reoperation, Esophageal hematoma Lap chole still not perfect return to normal activity 1 week, need to get to 1 day Risk of incisional hernia How to make TG chole “perfect” – margin of improvement is small

4. GOAL: Eliminate abdominal incisions particularly the transabdominal extraction site Potential Benefits: Reduce post-op pain Quicker return to normal activity (work, etc) Decrease incisional hernia Decrease incidence of wound infection Reduce health care costs (conscious sedation, endoscopy suite) Improve cosmesis Potential Risks: Bleeding Infection Gastric leak – peritonitis Esophageal leak – mediastinitis Bile tract injury Bowel injury

5. CURRENT STATUS OF TG CHOLECYSTECTOMY (Mini-laparoscopy with specimen extraction – based on safety): Indications Cholelithiasis Biliary dyskinesia GB polyp <1cm Contraindications Prior upper abdominal surgery Esophageal disease Large gallstones - >1.5 cm “bag of stones” – inability to measure largest stone size on U/S Acute cholecystitis Suspicion of GB carcinoma

6. Procedure Antibiotics Systemic - yes Luminal – no PPI – off for 2 weeks DVT prophylaxis – standard Operator Access – surgeon +/- gastroenterologist Dissection - surgeon Closure – surgeon +/- gastroenterologist Access 5mm umbilical port with laparoscopic visualization for all gastric access Optimal placement to reach GB Avoid bleeding Needle knife and balloon dilation recommended Pre-placement of suture to create gastric valve may facilitate closure Overtube

7. Visualization Liberal use of laparoscope Insufflation gas – CO2 via laparoscopic port Retraction 1 or 2 additional 2 or 3mm retraction ports/instruments EndoGrab Suture retraction Dissection Critical view of safety necessary Liberal laparoscopic assistance Cystic artery/duct control Laparoscopic clip Current commercially endoscopic clips should NEVER be used

8. Liver dissection- ESD techniques (saline injection) may facilitate Specimen retrieval – into overtube Cholangiogram – percutaneous if needed Closure Must be full thickness Laparoscopic closure recommended Pre-placement of suture to create gastric valve may help maintain gastric distention and facilitate endoscopic suturing/anchor deployment Use of balloon dilator helpful to maintain gastric distention and facilitate endoscopic suturing/anchor deployment Conversion to lap or open Bleeding Suspicion of bile tract injury Bowel injury

9. OBSTACLES TO ADOPTION: Surgeon: Safety (Need more publications including NOSCAR trial demonstrating reduced complications) Training Equipment – lack of enabling technologies Cost ( USGI TransPort $3-4K) Industry Safety Cost (Development, Previous Investment) Regulatory (Need a NOTES indication, perhaps from ongoing IDE trial) Institution/Hospital Safety Cost Equipment (i.e. USGI TransPort $3-4K) OR time

10. FUTURE (IDEAL) including enabling technologies and time line: Indications All benign GB indications including acute cholecystitis Contraindications Prior upper abdominal surgery Suspicion of GB carcinoma Procedure Antibiotics – 1 pre-op IV dose PPI – off for 2 weeks DVT prophylaxis – standard Operator – NOTES surgeon

11. Access No laparoscopic visualization Optimal location of gastrotomy to reach retracted GB (Data from peritoneoscopy studies, Time line, 1-2 years) Incorporated overtube and closure device (Time line, 3-5 years) Visulization – off axis Magnetic anchoring – (Time line, 1-2 years) “Cobra” view with independent camera navigation (i.e. Endo Samurai Equivalent, Time line, 3-5 years) Insufflation – CO2 via overtube or endoscope Gallbladder Retraction No laparoscopic assistance Endoscopic retraction device (Time line, 1-2 years) Dissection Surgical paradigm – non-dominant arm retract, dominant arm dissect (Need flexible platform that retroflexes and locks or becomes rigid, i.e. Endo Samurai equivalent; Time line 3-5 years) Critical view of safety necessary always obtained

12. – – Cystic artery/duct control Multifire endoscopic clip/coil deployment (Time line, 1-2 years) Flexible vessel/duct sealing (Time line, 1-2 years) – – Bipolar electrocautery – – Thermal energy – – Liver dissection Surgical paradigm – non-dominant arm retract, dominant arm dissect (Need flexible platform (60F max diameter) that retroflexes and locks or becomes rigid, i.e. EndoSamurai equivalent; Time line 3-5 years) ESD techniques (saline injection)may facilitate – – Specimen retrieval Stones > 1.5cm or “bag of stones” : – – Open GB, crush large stones and let pass or individually remove stones <2cm with basket, retrieve GB » » Need intragastric stone crusher Mechanical, Time line 1-2 years Laser, Time line – now Lithotripsy: Time line, now – – Morcellate entire specimen » » Need endoscopic morcellator, Time line 1-2 years

13. Bile duct evaluation Intra-op endoscopic cholangiography Mini-endoscopic ultrasound Closure Easy and reliable endoscopic deployment (Time line, 1-2 years) Clip Stapler Plug Glue Integrated access and overtube (Time line, 3-5 years) Endoscopic leak test Leak rate < 1%

14. Summary Safety is main concern Current state Mini-laparoscopy with specimen extraction Future Surgical paradigm platform Integrated Access/Closure