MINI GASTRIC BY-PASS IN ITALY MULTICENTRE REVIEW 2006-2012 Università degli Studi di Napoli “Federico II” Dipartimento di Scienze Biomediche Avanzate Chirurgia Generale M. Musella M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Che intervento è? E’ lecito eseguirlo? E’ vantaggioso eseguirlo? Quali risultati? M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 12-14 cm long gastric pouch M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 200 – 220 cm from Treitz ligament M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 200 – 220 cm from Treitz ligament M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Che intervento è? E’ lecito eseguirlo? E’ vantaggioso eseguirlo? Quali risultati? M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 2001 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 2005 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 2005 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 2005 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 2008 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 2011 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 2011 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 2012 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 2012 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Biliary Gastritis Achloridria Mucosal chronic inflammation Nitrosoderivate activation Gastric stump cancer M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Biliary Gastritis Rutledge 2005 (2475 pts.) Carbajo 2005 (209 pts.) Chevallier 2008 (100 pts.) Noun 2012 (1000 pts) Lee 2012 (1163 pts.) 0.2% 0%* 2.0% 0%-5.1%** 3.7%*** M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Biliary Gastritis Johnson WH, Fernanadez AZ, Farrell TM, Macdonald KG, Grant JP, McMahon RL, Pryor AD, Wolfe LG, DeMaria EJ.(2007) Surgical revision of loop ("mini") gastric bypass procedure: multicenter review of complications and conversions to Roux-en-Y gastric bypass. Surg Obes Relat Dis. 2007 Jan-Feb;3(1):37-41. M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Gastric stump cancer Caygill CP, Hill MJ, Kirkham JS, Northfield TC (1986) Mortality from gastric cancer following gastric surgery for peptic ulcer. Lancet 1(8487):929-31. Viste A, Bjørnestad E, Opheim P, Skarstein A, Thunold J, Hartveit F, Eide GE, Eide TJ, Søreide O (1986) Risk of carcinoma following gastric operations for benign disease. A historical cohort study of 3470 patients. Lancet 2(8505):502-5. Lundegårdh G, Adami HO, Helmick C, Zack M, Meirik O (1988) Stomach cancer after partial gastrectomy for benign ulcer disease. N Engl J Med 319:195-200. M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Gastric stump cancer Fischer AB, Graem N, Jensen OM. Risk of gastric cancer after Billroth II resection for duodenal ulcer (1983) Br J Surg 70:552-4. Tokudome S, Kono S, Ikeda M, Kuratsune M, Sano C, Inokuchi K, Kodama Y, Ichimiya H, Nakayama F, Kaibara N, et al. (1984) A prospective study on primary gastric stump cancer following partial gastrectomy for benign gastroduodenal diseases. Cancer Res 44:2208-12. M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Gastric stump cancer M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Gastric stump cancer M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Gastric stump cancer Bassily R, Smallwood RA, Crotty B. (2000) Risk of gastric cancer is not increased after partial gastrectomy. J Gastroenterol Hepatol. Jul;15(7):762-5. The records of a total of 569 patients who had a partial gastrectomy for peptic ulcer disease at Repatriation General Hospital, Heidelberg, between 1957 and 1976 were reviewed. Duration of follow up was 17.3 years (range 1-41 years). The expected number of cancers in this population was 6.5. Assuming all survivors were free of gastric cancer, the standardized incidence ratio was 1.39 (95% confidence intervals 0.64-2.65, P=0.313). The risk of gastric cancer was not increased after partial gastrectomy in this Australian population. M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Esophago Gastric cancer M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Esophago Gastric cancer 33 esophagogastric cancers (ca) 4 ca (12.1%) following a loop bypass (not better described) 3 ca located in the excluded stomach 1 ca located in the gastric pouch following a 1980 surgery 15 ca (45.4%) following restrictive procedures (LAGB, SG, VBG) 14 ca (42.4%) following RYGBP (5 located in the excluded stomach) M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Che intervento è? E’ lecito eseguirlo? E’ vantaggioso eseguirlo? Quali risultati? M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 M. Musella - SICOB - Cagliari 04/13 M. Musella - SICOB - Cagliari 04/13 M. Musella - SICOB - Cagliari 04/13 M. Musella - SICOB - Cagliari 04/13 M. Musella - SICOB - Cagliari 04/13 M. Musella - SICOB - Cagliari 04/13 M. Musella - SICOB - Cagliari 04/13 M. Musella - SICOB - Cagliari 04/13 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Che intervento è? E’ lecito eseguirlo? E’ vantaggioso eseguirlo? Quali risultati? M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Dal 11/07/2006 al 31/12/2012 abbiamo valutato i risultati ottenuti dall’esecuzione del Mini Gastric Bypass laparoscopico, per la cura dell’obesità e di alcune comorbilità associate ad essa, eseguiti nei seguenti centri : Centers Patients Musella 52 Piazza 380 Greco 70 Susa 406 De Luca 45 Manno 21 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Sono stati eseguiti un totale di 974 interventi 475 pazienti maschi 499 pazienti femmine (28%) (71,69%) BMI medio = 48 ± 4,579 Età media della popolazione = 39,45 anni M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Main Preoperative Parameters Pts Number (%) Hypertensive Pts (%) Diabetic Pts (%) BMI < 30 2 (0.2) 0 2 (100) 30<BMI<35 54 (5.5) 13 (24.0) 30 (55.5) 35<BMI<40 192 (19.7) 38 (19.7) 38 (19.7) 40<BMI<50 416 (42.7) 90 (21.6) 53 (12.7) 50<BMI<60 257 (26.3) 116 (45.1) 89 (34.6) 53 (5.4) 34 (64.1) 12 (22.6) 974 (100) 291 (29.8) 224* (22.9) BMI > 60 Total M. Musella - SICOB - Cagliari 04/13 Calibre of the bougie : • 42 fr (380 patients) • 40 fr (70 patients) • 36 fr (524 patients) Loop lenght : 224.6 ± 23.2 cm M. Musella - SICOB - Cagliari 04/13 Size of the blue cartdrige linear stapler (gastrojejunal anastomosis): • 30 mm (70 patients) • 45 mm (451 patients) • 60 mm (453 patients) Stapler holes closure method: • Double layer running 2-0 suture (573 patients) • Single layer running 2-0 suture (21 patients) • Interrupted 2-0 stitches (380 patients) Reinforcement of the suture line: • Fibrin sealant (52 patients) • Oversewing (45 patients) M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 In 451 patients an anti-biliary reflux mechanism was provided. All 974 patients were checked by an intraoperative methylene blue test at the end of the procedure M. Musella - SICOB - Cagliari 04/13 TOTALE PAZIENTI DECEDUTI • 2/974 = 0,2% PAZIENTI DECEDUTI PER COMPLICANZE NON RELATIVE ALLA PROCEDURA • 1/974 = 0,1% •Trombo-embolia polmonare •Infarto del miocardio •Ischemia cerebrale •Insufficienza renale acuta 3 casi (0,3%) di cui 1 decesso (25%) 0 casi 1 caso (0,1%) 0 casi PAZIENTI DECEDUTI PER COMPLICANZE RELATIVE ALLA PROCEDURA: • 1/974 = 0,1% LEAK ANASTOMOSI = 3 casi (0,3%) di cui 1 decesso (33%) LEAK TUBULO GASTRICO= 5 casi (0,5%) LEAK MONCONE GASTRICO= 2 casi (0,2%) BLEEDING= 25 casi (2,5%) EMORRAGIE DIGESTIVE= 9 casi (0,9%) M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Peri-operative complications Pts Number (%) Pts/Days from Surgery Surgical revisions/Complications (%) 3*/974 (0.3) 2*/1d; 1/15d - Stroke 1/974 (0.1) 1/20d - Respiratory distress 1/974 (0.1) 1/1d - GJ Anastomosis leak 3*/974 (0.3) 1*/1d; 1/2d; 1/5d 1/3 Gastric pouch leak 5/974 (0.5) 4/2d; 1/3d 5/5 Gastric remnant leak 2/974 (0.2) 1/2d; 1/12d 0/2 Abdominal bleeding 25/974 (2.5) 25/1d 9/25 GI bleeding 9/974 (0.9) 5/3d; 3/5d; 1/9d 1/9 Gastric perforation 2/974 (0.2) 2/1d 2/2 Jejunal perforation 3/974 (0.3) 3/2d 2/2 Total 54/974 (5.5) PE M. Musella - SICOB - Cagliari 04/13 20/48 (41.6) Follow up outcome 12 months 36 months 60 months Pts in follow up/Pts operated 795/974 (81.0%) 510/974 (52.3%) 201/974 (20.6%) Weight (Kg) 91.5 ± 18.5 79.1 ± 8.55 81.7 ± 23.15 BMI 31.88 ± 4.91 27.5 ± 2.12 28 ± 2.25 EWL% 70.12 ± 8.35 81.5 ± 4.95 77 ± 5.14 diabetes pts in remission/ diabetes pts in follow up 175/201 (87.0%) 160/186 (86.0%) 87/103 (84.4%) hypertensive pts healed/ hypertensive pts in follow up 172/190 (90.5%) 132/155 (85.1%) 84/96 (87.5%) M. Musella - SICOB - Cagliari 04/13 Follow up complication rate Pts Number (%) Surgical revisions/Complications (%) Gastric pouch enlargment 4/974 (0.4) 0/4 Trocar hernia 1/974 (0.1) 1/1 EWL > 100% 1/974 (0.1) 1/1 Weight regain 2/974 (0.2) 1/2 Anastomotic ulcers 14/974 (1.4) 4/14 Biliary gastritis 8/974 (0.8) 0/8 Iron deficiency anemia 44/974 (4.5) - Total 74/974 (7.5) 7/30 (23.3) M. Musella - SICOB - Cagliari 04/13 Present study Rutledge(2) Noun(8) Carbajo(4) Chevallier(5) Lee(16) Operative time* 9551.6 37.5 8912.8 93.0^ 12937 115.324.6 Conversion rate 1.2% 0.17% - 0.9% - 0.1% Mortality 0.2% 0.08% - 0.9% - 0.17% Short term complications (STC) 5.5% 5.9% 2.7%^ 4.4% 7% 8.5% STC requiring surgical repair 2.0% 1.16% 0.2%^ 1.4% 6% 1.8% Long term complications (LTC) 7.4%° 11.6%° 4.1%^ 8.1%° 4% 2.8% LTC requiring surgical repair 0.7% 1.1% 3.4%^ - - 2.8% EWL% at 1 year 70.1±8.35 80 69.9±23.1 75 63±14 64.9±9.5(3) EWL% at 3 years 81.5±4.95 80 72.2±22 - - - EWL% at 5 years 77±5.14 80 68.6±21.9 - - 72.9±19.3 - - 93%(17) - - - T2DM resolution at 1 year 87% T2DM resolution at 3 years 86% 83% 85% M. Musella - SICOB - Cagliari 04/13 M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Conclusioni 1. E’ un intervento eseguibile senza rischi per il paziente 2. E’ un intervento vantaggioso per il paziente… 3. E’ un intervento che ha dimostrato una efficacia sovrapponibile e in alcuni parametri anche superiore al RYGBP M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Mail to: [email protected] M. Musella - SICOB - Cagliari 04/13 Mini Gastric Bypass in Italy 2006-2012 Il giorno 17/apr/2013, alle ore 09.46, Dr Rutledge ha scritto: Looks Great! May I advertise it, Please? Translation: 10:30 to 11:30 SESSION III MINIGASTRIC BYPASS: OPINION OF EXPERTS Chairman: C. Giardiello (Caserta) Moderators: L. Square (Catania), A. Susa (Rovigo) M. Musella - SICOB - Cagliari 04/13