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2010 NOTES ® Summit Working Group Report

2010 NOTES ® Summit Working Group Report. Transgastric cholecystectomy. July 8-10, 2010 Chicago, IL. Published cases: Zorron et al 2010 – 29 hybrid (Salinas et al – 27 cases hybrid): Endoscopic or laparoscopic dissection Operator: Surgeon predominance

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2010 NOTES ® Summit Working Group Report

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  1. 2010 NOTES® SummitWorking Group Report Transgastric cholecystectomy July 8-10, 2010Chicago, 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

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