Tecniche open e laparoscopiche a confronto: a che punto siamo. Ruolo della chirurgia robotica Dr. Francesco Ricci

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1 Azienda Ospedaliera S. Maria Terni S.C. di Chirurgia Digestiva e d Urgenza Direttore Dr. Amilcare Parisi Tecniche open e laparoscopiche a confronto: a che punto siamo. Ruolo della chirurgia robotica Dr. Francesco Ricci

2 ROBOTIC SURGERY IN ITALY Robotic systems in Italy Number of robotic procedures in Italy per year

3 WHAT S NEW IN ROBOTIC SURGERY How Robotic Technology is Revolutionizing our Approach in Gastrointestinal Surgery? New robotic systems - Robot Xi Advanced robotic devices - Stapler - Vessel Sealer Integrated images - Ultrasound, Ct scan, Endoscopy, 3-D vision - Fluorescence Guided Surgery Teaching - Dual console - symulator Development of new techniques - Reconstruction after total gastrectomy - Intrathoracic esophagogastric anastomosis Continuing surgical research

4 WHAT S NEW IN ROBOTIC SURGERY The Xi System: A Mobile Tower-Based Robot The robotic console is designed to permit the operator to see the 3Dview of the operating field and ultrasound images simultaneously. The Xi robotic platform provides additional advantages, like integrated near-infrared fluorescence imaging. The Xi robot represents a fourthgeneration robotic system and evolution from the previous Si version. Easier and faster docking due to an automatic targeting system, the smaller 8mm camera s increased versatility, and improved arm movements are the main technological developments.

5 WHAT S NEW IN ROBOTIC SURGERY Robotic Devices Single Port Robotic Surgical System EndoWrist Vessel Sealer EndoWrist Stapler

6 WHAT S NEW IN ROBOTIC SURGERY Fluorescence Guided Surgery Development of a new concept of surgery: Navigation Surgery Targeted Surgery Study Proposal: Fluorescence Image-Guided Lymphadenectomy Using Indocyanine Green And Near Infrared Technology In Robotic Gastrectomy

7 WHAT S NEW IN ROBOTIC SURGERY Robotic Training Curriculum Skills Simulator contains a variety of exercises and scenarios specifically designed to give users the opportunity to improve their proficiency The development of the dualconsole da Vinci Surgical System (Si and Xi) has enabled modification of the training

8 STATE OF THE ART Investigation al treatments Minimally Invasive Surgery Robotic surgery

9 STATE OF THE ART ROBOTIC SURGERY LAPAROSCOPIC SURGERY The number of laparoscopic gastrectomies is increasing Laparoscopy has been evaluated as an alternative to open surgery with the potential benefits of decreased operative morbidity and reduced recovery times The benefit has only been shown by small comparative studies Meta-analyses confirm benefits in clinical outcomes, though some concerns remain regarding long-term outcomes and the possibility for reduced nodal harvest Robotic surgery is not even mentioned in the current guidelines

10 STATE OF THE ART What skills can be improved in gastric surgery? The robotic surgery system facilitates the process of performing laparoscopic surgery and provides: Three dimensional (3D)- image Motion scaling Tremor filtering Coaxial alignment of the eyes, hands, and tool tip image. An intuitive translation of the instrument handle to the tip movement, thus eliminating the mirror image effect. An internal articulated endoscopic wrist, providing an additional three degrees of freedom. This computer-enhanced surgical system thus allows surgeons to overcome various difficulties during endoscopic surgery: Lymphadenectomy include LN no. 8a, 9, 11p, 11d, 12a Isolation of diaphragmatic crura Lymphadenectomy in obese and bleeding control Esophagojejunal reconstruction

11 LITERATURE REVIEW Lymph-node dissection TYPE SAMPLES (NO.) D2 PROCEDURES (NO.) RETRIEVED LN (MEAN) P VALUE Kim KM RG Vs LG Vs OG 436 / 861 / 4542 Not reported 40,2 / 37,6 / 40,5 <0,001 Huang RG Vs LG Vs OG 39 / 64 / / 12 / / 26 / 34 <0,001 Caruso RG Vs OG 29 / / / ,02 Kim MC RG Vs LG Vs OG 16 / 11 / / 8 / / 37,4 / 43,3 0,3 Patriti RG Vs OG 14 / / 13 28,1 / 23,7 NS Pugliese RG Vs LG 31 / / / 52 not reported Woo RG Vs LG 236 / / / 37,4 0,3 Eom RG Vs LG 30 / / / ,1 Hyun RG Vs LG 38 / / 18 32,8 / 32,6 0,9 Junfeng RG Vs LG 120 / 394 Not reported 34,6 / 32,7 0,01 Kang RG Vs LG 100 / 282 Not reported Not reported Not reported Kim HI RG Vs LG 172 / / ,3 / 36,8 0,8 Noshiro RG Vs LG 21 / / / 40 0,2 Park RG Vs LG 30 / 120 Not reported 34 / 35 0,6 Son SY RG Vs LG 21 / 42 8 / 20 46,5 / 39,7 0,6 Son T RG Vs LG 51 / / 58 47,2 / 42,8 0,2 Song RG Vs LG 20 / 20 4 / 10 35,3 / 31,5 0,3 Suda RG Vs LG 88 / / / 38 0,1 Uyama RG Vs LG 25 / / ,3 / 43,2 0,7 Yoon RG Vs LG 36 / 65 Not reported 39,4 / 42,8 0,2

12 TECHNICAL NOTE Lymph-node dissection

13 RECONSTRUCTION The possibility of safely achieving intracorporeal anastomosis in place of extracorporeal procedures is currently being debated. Advantages and limits have not been highlighted by current studies. Robots can help surgeons because of the precise three-dimensional view and the instruments with seven degrees of freedom. Lack of scientific evidence

14 RECONSTRUCTION Reconstruction in Distal Gastrectomy

15 RECONSTRUCTION

16 LITERATURE REVIEW YEAR TYPE SUBJECT COUNTRY INSTITUTION PERIOD NO. Jiang 2015 Retrospective CS RAG China Nanjing University Medical College Kim KM 2012 nonrct RAG vslg vsog Son T nonrct RTG vs LTG Korea Yonsei University College of Medicine Woo 2011 nonrct RAG vs LG Song 2009 Prospective CS RAG Park 2013 Retrospective CS RAG Korea National Cancer Center Yoon 2012 nonrct RTG vs LTG Kang 2012 nonrct RAG vs LG Ajou University School of Medicine Korea Hur 2010 Retrospective CS RAG Hyun 2013 nonrct RAG vs LG Korea Korea University Anam Hospital Son SY 2012 nonrct RAG vs LG Korea Seoul University Bundang Hospital Junfeng 2014 nonrct RAG vs LG China Third Military Medical University Liu 2013 Prospective CS RAG China Subei People's Hospital of Jiangsu Giulianotti 2003 Retrospective CS RAG Italy 10 Misericordia Hospital of Grosseto Coratti 2015 Retrospective CS RAG Italy 38 D Annibale 2011 Retrospective CS RAG Italy S. Giovanni Addolorata Hospital Caruso 2011 nonrct RAG vs OG Italy Hospital of Spoleto Suda 2014 nonrct RAG vs LG Japan Fujita Health University Huang 2012 nonrct RAG vs LG vs OG Taiwan Taipei Veterans General Hospital Vasilescu 2012 Retrospective CS RAG Romania Fundeni Clinical Institute Zawadzki 2014 CR RAG Poland Wroclaw Medical University Parisi 2015 Prospective CS RTG Italy St. Mary s Hospital of Terni Parisi 2017 Prospective CS RTG Italy St. Mary s Hospital of Terni TOTAL

17 LITERATURE REVIEW Lymphadenectomy Robot - Assistance Stomach mobilization Reconstruction Type E-J Anastomosis Anastomosis performance Site of minilaparotomy Operative /Clinical Data Patient/ tumor details Jiang performed Performed Roux-en-Y EXTRA Circular stapler Not provided provided Provided Performed Roux-en-Y INTRA Robot-sewn Not provided Kim KM Not provided Not provided Not provided Roux-en-Y Not provided Not provided Not provided lack Lack Son T. performed Performed Roux-en-Y EXTRA Circular stapler Upper midline provided Provided Roux-en-Y INTRA LAP Circular stapler Left lower port Woo performed Performed Roux-en-Y EXTRA Not provided Not provided lack Lack Roux-en-Y INTRA LAP Not provided Not provided Song performed Performed Roux-en-Y EXTRA Circular stapler Upper midline lack Lack Roux-en-Y INTRA LAP Circular stapler Not provided Park performed Performed Roux-en-Y EXTRA Not provided Upper midline provided Lack Yoon performed Performed Roux-en-Y EXTRA Circular stapler Not provided provided Provided Kang performed Performed Roux-en-Y EXTRA Circular stapler Upper midline lack Lack Performed Roux-en-Y INTRA Robot-sewn Not provided Hur performed Performed Performed Roux-en-Y INTRA Robot-sewn Not provided lack lack Hyun performed Performed Roux-en-Y EXTRA Circular stapler Upper midline lack lack Not provided Roux-en-Y INTRA Not provided Umbilical port Son SY performed Performed Roux-en-Y EXTRA Not provided Not provided lack lack Junfeng performed Performed Roux-en-Y EXTRA Circular stapler Upper midline provided provided Liu performed Performed Performed Roux-en-Y INTRA Robot-sewn Camera port lack lack Giulianotti performed Performed Performed Roux-en-Y INTRA Circular stapler Not provided lack lack Coratti performed Performed Performed Roux-en-Y INTRA Robot-sewn Not provided provided provided D Annibale performed Performed Performed Roux-en-Y INTRA Circular stapler Suprapubic lack lack Caruso -Patriti performed Performed Performed Roux-en-Y INTRA Circular stapler Upper midline lack lack Suda performed Performed Performed Roux-en-Y INTRA Linear stapler Not provided provided provided Huang Performed Performed Roux-en-Y INTRA LAP Circular stapler Periumbilical lack lack Vasilescu performed Performed Performed Roux-en-Y INTRA Circular stapler Not provided Lack lack Parisi performed Performed performed Roux-en-Y INTRA Robot-sewn McBurney provided Provided

18 LITERATURE REVIEW SURGICAL STRATEGY FOR RECONSTRUCTION AFTER ROBOTIC TOTAL GASTRECTOMY 1. Surgical approach: Extracorporeal vs. Intracorporeal Mini-laparotomy robotic / laparoscopic 2. How to perform the Roux-en-y?

19 LITERATURE REVIEW Extracorporeal anastomoses Minilaparotomy (5-6 cm) through which the ends that need to be anastomosed are brought out and continuity of the digestive tract is reestablished usually with the aid of a circular stapler Son T. Woo Song Park Yoon Kang Hyun Son SY Jiang Junfeng Intracorporeal Anastomosis Avoid the laparotomy and imply performing anastomosis under video assistance by different solutions Laparoscopic assistance Son T. Woo Song Huang Robotic assistance Jiang Liu Parisi Kang Hur Hyun Giulianotti D annibale Patriti Suda Vasilescu

20 LITERATURE REVIEW End-to-Side Mechanical anastomosis Side-to-Side Entirely manual suturing Circular stapler Anvil placement Creation of the purse-string suture Linear stapler Jiang Liu Kang - Hur Parisi (Double Loop) Manual purse-string suture The anvil is introduced in the esophagus after performing a manual purse-string. The shaft of the stapler is introduced in the jejunal limb through an incision, and then the two sides are stapled together. Giulianotti D annibale Using the OrVil The anvil is delivered transorally and the anastomosis is performed using the shaft of a stapler introduced through the jejunal stump. Vasilescu Overlap technique The linear stapler is introduced through a jejunal incision and the esophagus. The two ends are stapled together and the remaining orifice is sewn manually. Suda Vasilescu

21 DOUBLE LOOP RECONSTRCUCTION APPROACH

22 DOUBLE LOOP RECONSTRCUCTION APPROACH The Double loop technique is a simplification of the traditional technique of construction of the Roux-limb: -The first loop of bowel is brought up antecolic and an End-to-Side esophago-jejunal anastomosis is performed with the robot. -A second loop of bowel, distal from the esophago-jejunal anastomosis is brought up to the afferent first loop and the enteroenteric anastomosis is performed manually or mechanically. -Finally the bowel is interrupted between the EJ and the EE anastomosis to create the Roux-en-Y. Procedure performed by Dr. Parisi at the St. Mary s Hospital of Terni Parisi, A., et al., Robotic Total Gastrectomy With Intracorporeal Robot-Sewn Anastomosis: A Novel Approach Adopting the Double-Loop Reconstruction Method. Medicine (Baltimore), (49): p. e1922 Parisi, A., et al., Robotic double-loop reconstruction method following total gastrectomy. Endoscopy, Suppl 1: p. E55-6

23 DOUBLE LOOP RECONSTRCUCTION APPROACH PRELIMINARY DATA Table 1: Table 2: Table 3:

24 DOUBLE LOOP RECONSTRCUCTION APPROACH PRELIMINARY DATA

25 DOUBLE LOOP RECONSTRCUCTION APPROACH Robotic total gastrectomy with double loop reconstruction is safe and feasible in our experience. This technique seems to overcome the difficulties and risks associated with other reconstruction procedures and in high BMI patients. Robotic technology facilitates the execution of hand sewn anastomosis and totally intracorporeal procedures, even in surgeries that require delicate and advanced sutures. Post-operative outcomes are satisfactory and functional recovery is immediate.

26 TECHNICAL NOTE Minimally Invasive Ivor-Lewis Esophagectomy: Robot-Sewn Anastomosis

27 ERAS MANAGEMENT

28 INFORMATION ACKNOWLEDGEMENTS JOIN THE STUDY

29 DATA FROM THE IMIGASTRIC STUDY

30 ROBOTIC GASTRECTOMY IN ITALY: DATA ANALYSIS Patients Characteristics Total No. 222 Age 68,76 ± 12,57 Sex (F/M) 98 / 124 BMI 24,58 ± 3,23 ASA I 33 (14,9%) II 122 (55,0%) III 67 (30,2%) Comorbidities 113 (50,9) Procedures details Distal 161 (74,19) Total 56 (25,81) Type of reconstruction Billroth II 74 (33,3) Roux-en-Y G-J 87 (39,2) Roux-en-Y E-J 57 (25,7) Pathology 0 4 (1,8) I A 56 (25,2) I B 37 (16,7) II A 39 (17,6) II B 23 (10,4) III A 31 (14,0) III B 20 (9,0) III C 12 (5,4) Undifferentiated 85 (54,8)

31 ROBOTIC GASTRECTOMY IN ITALY: DATA ANALYSIS Surgical Outcomes Operative time (min) 348,73±95,76 EBL (ml) 137,93±77,3 retrieved lns (no.) 27,47±12,72 intraop. complications 3 (1,4) intraop. transfusions 4 (1,8) R0 resections 217 (97,7) Clinical Outcomes Hospital Stay 8,74±4,84 Mobilization 1,20±1,00 Liquid Diet 3,12±2,24 Solid Diet 4,18±2,01 First Flatus 3,37±1,33 Drain Removal 5,35±2,57 Analgesic Use 3,12±1,55

32 ROBOTIC GASTRECTOMY IN ITALY: DATA ANALYSIS Complications Pts with complications (no.) 37 (16,7) Non-surgical related (%) 12 (29,3) Surgical-related (%) 29 (70,7) Clavien Dindo grade I+II 36 (87,8) IIIa 0 (0) IIIb 5 (12,2) V (Death) 0 (0) Reoperation 5 (2,3) Complications after Discharge 10 (4,5) Analysis of Leakage Site of leak BII duodenal stump 0 (0) E-J 1 (16,7) G-J 3 (50) Roux duodenal stump 2 (33,3) Leak-related reoperation 1 (16,7) Leak-related death 0 (0)

33 INFORMATION ACKNOWLEDGEMENTS JOIN THE STUDY