NOSCAR 2010 SOLID ORGAN n SOLID ORGAN Opportunity

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NOSCAR 2010 SOLID ORGAN

NOSCAR 2010 SOLID ORGAN

n SOLID ORGAN Opportunity for clinical utilization n Procedure n Benefits and risks n

n SOLID ORGAN Opportunity for clinical utilization n Procedure n Benefits and risks n Operator n Volume n Timeline n Obstacles for adoption n Enable technology needed?

SOLID ORGAN n Opportunity for clinical utilization n Procedures – Organ removal n n

SOLID ORGAN n Opportunity for clinical utilization n Procedures – Organ removal n n Nephrectomy, Spleenectomy, (already published) Hepatectomy, pancreatectomy (tail), adrenalectomy… n n Actually feasible with hybrid approach and use of rigid instruments Real benefits for specimen removal and optics site on natural orifice n n n Mainly transvaginal Progress to real NOTES relay on tech development like Flexible staplers and platforms Potential use of combined approach

SOLID ORGAN n Opportunity for clinical utilization n Benefits and risks –Organ removal n

SOLID ORGAN n Opportunity for clinical utilization n Benefits and risks –Organ removal n Benefits n n n Removal using natural orifices reduces abdominal wall damages of larger incisions Natural orifices are really near to target organs Risks n Major challenges coming of bleeding from larger vessels

SOLID ORGAN n Opportunity for clinical utilization n Operator – Organ removal n n

SOLID ORGAN n Opportunity for clinical utilization n Operator – Organ removal n n Those are complex surgical procedures generally done by specialists Keys to development n Identify the target groups n Enrol them on NOTES training

SOLID ORGAN n Opportunity for clinical utilization n Timeline – Organ removal n Actually

SOLID ORGAN n Opportunity for clinical utilization n Timeline – Organ removal n Actually – Vaginal access n n n Up to 3 y n n Hybrid technique with rigid instruments make it feasible and seems to be safe (nephrectomy and splenectomy) Competes with single-site laparoscopy More use of combined approach Reduce the use of transabdominal rigid instrumentation n New long steerable instruments ? n Magnets? Development of flexible stapling n Specific designed to vessel control with smaller diameter Over 3 y n Platform development will allow progression toward NOTES

SOLID ORGAN n Opportunity for clinical utilization n Obstacles for adoption – Organ removal

SOLID ORGAN n Opportunity for clinical utilization n Obstacles for adoption – Organ removal n Competes with single-site surgery n Lack of large vessels control (flexible stapling) n Scaling (not so many procedures done) n Procedures done by “specialists” that are note involved with NOTES

SOLID ORGAN n Opportunity for clinical utilization n Enable technology needed – Organ removal

SOLID ORGAN n Opportunity for clinical utilization n Enable technology needed – Organ removal n Flexible stapling (vessels orientated) n Long steerable instruments n Magnets n NOTES surgical platforms

SOLID ORGAN n Opportunity for clinical utilization n Procedures -Diagnostic and non-organ removal n

SOLID ORGAN n Opportunity for clinical utilization n Procedures -Diagnostic and non-organ removal n Biopsy – Hepatic biopsy as killer app n Tumor ablation n n Actually not on the highlight Real benefits in competing with transabdominal approach in selected cases in-witch it can not reach the target or is ‘too risky” to do it n Enables large volume caseload n Could make transgastric approach feasible and “popular”

SOLID ORGAN n Opportunity for clinical utilization n Benefits and risks –Diagnostic and non-organ

SOLID ORGAN n Opportunity for clinical utilization n Benefits and risks –Diagnostic and non-organ removal n n Benefits n Potential use for sedation / endoscopic suites n Smaller diameter scopes can be used n Enrol the gastroenterologists on this process n Real visualization / Reach the target Risks n Potential risks of the transgastric closure

SOLID ORGAN n Opportunity for clinical utilization n Operator – Diagnostic and non-organ removal

SOLID ORGAN n Opportunity for clinical utilization n Operator – Diagnostic and non-organ removal n Gastroenterologists for diagnoses n Surgeons for ablation n Keys to development n n Find a simple and safe way to do the gastrotomy and to close it “ 10 min procedure for hepatic biopsy”

SOLID ORGAN n Opportunity for clinical utilization n Timeline – Diagnostic and non-organ removal

SOLID ORGAN n Opportunity for clinical utilization n Timeline – Diagnostic and non-organ removal n Actually n n Up to 1 -2 y n n n Not seeing as a target for the ones interested on NOTES Technology is available Still looking for different ways to do the gastrectomy and how to close it Define and standardize the method (grastrotomy) Run and maybe sponsor a bases trials Over 3 y n Adoption based on trial results

SOLID ORGAN n Opportunity for clinical utilization n Obstacles for adoption – Diagnostic and

SOLID ORGAN n Opportunity for clinical utilization n Obstacles for adoption – Diagnostic and non-organ removal n n n Lack of clinical knowledge about the safety of gastrotomy closure A simple and fast way to do that The established culture of image guided transcutaneous access to intra-abdominal biopsy and ablation

SOLID ORGAN n Opportunity for clinical utilization n Enable technology needed – Organ removal

SOLID ORGAN n Opportunity for clinical utilization n Enable technology needed – Organ removal n “Gastrotomy access kit” n To open and close n Flexible biopsy instruments for solid organs n Flexible ablation instrumentation