Opciones quirúrgicas válidas r cohen

Ricardo Cohen MD Novel GI procedures for low BMI T2DM The Center for the Surgical Treatment of Morbid Obesity and Metabolic Disorders. Hospital Oswaldo Cruz , Sao Paulo, Brazil President, Brazilian Society for Bariatric and Metabolic Surgery

Research Grant, Covidien Research Grant, GI Dynamics SAB, GI Dynamics Disclosures

Why address low BMI patients? What’s the background for novel procedures? Critical analysis of DJB and I T Do we need novel procedures?

Need to address the “real world” in investigational protocols 50 % of Diabetics in the world have BMI<35 Int J Clin Practice, 2007(NHANES and SHIELD) Dtsch Int Arztebl. 2010, 107 SOARD, 2010

RYGB tested in BMIs 30-35 with sustained ( 6 years) DM remission and weight loss. Why novel procedures? Cohen,2006; Cohen and Cummings, 2010

Do lower BMIs need massive weight loss? Do low BMI pts, with mild insulin resistance need the pylorus to conquer better glycemic/metabolic control?

BPD Scopinaro may achieve good long term glycemic/metabolic control in lower BMIs. But are the nutritional risks worth the operation? Scopinaro, 2011

Is there any phisiological importance for preserving the pylorus? Delaying gastric emptying proved to be an efficient mean of reducing postprandial glucose excursions in diabetics and healthy subjects secondary to incretin effect The higher the glucose loads pronounced decrease in gastric emptying Glucose excursions are dampened and prolonged, serving to avoid proximal bowel glucose overload Nauck, 1986; Pilichiewicz, 2007; Bagger, JCEM, March 2011 SO, PRESERVING THE PYLORUS MAY BE IMPORTANT TO DM CONTROL AFTER GI SURGERY

Ileal Transposition with sleeve gastrectomy and with or without duodenal exclusion without duodenal exclusion

What are the proposed novel procedures? Duodenal jejunal bypass

Text Not at new concept at all !! Studied back on early 80’s by Koopmans and Scalfani in animals. Very high mortality rates reported in animals

IT + SG +- Duodenal Exclusion IT + SG IT+ SG + Duodenal Exclusion 1) Surg Endosc, March 2008 2) Surg Endosc, Jun 2008 3)Surg Endosc, 2009 4)J Gastro Intest Surg, 2010 5) World J Surg, 2011 Almost Exclusively Championed by De Paula

Outcomes * A1c < 7 % #PTS Preop BMI(mean) TBWL % DM remission * FU (mean) Study 1,March2008 Both SGIT+DSGIT 39 30,1 22 86,9 7 mo Study 2,June 2008 Both SGIT+DSGIT 60 30,1 23 86,7 7,4 mo Study 3,2009 DSGIT ONLY 69 25,7 17,7 95,7 21,7mo Study 4,2010 Both SGIT+DSGIT 72 27 22 86,5 90% Lipid profile improvement 24,5 mo Study 5,2011 DSGIT ONLY 454 29,7 BMI to 25,9 @ 1 mo 1 mo study 1 mo study

DSGIT/SGIT Other outcomes Other outcomes Expressive lipid control Significant blood pressure control Reported improvement of macro and microalbumunuria

And Complications and Mortality? Major Complications(%) Intraop complications(%) Mortality(%) Study 1,March2008 Both SGIT+DSGIT 10,5 7,7 -30% related to ischemia of the transposed ileum 2,6 Study 2,June 2008 Both SGIT+DSGIT 11,7 5 0 Study 3,2009 DSGIT ONLY 7,7 5 0 Study 4,2010 Both SGIT+DSGIT 13,9 8,3 0 Study 5,2011 DSGIT ONLY 6,4 4 -50% related to ischemia of the transposed ileum 0,4

10 pts, mean BMI 33.8 kg/m2 9 mo follow up 70% remission(A1c<7) WL between 15 and 30% (TBWL) Mortality and complications not reported

Seems effective, but very complex : Expressive and rapid WL, that can be credited for short/mid term improvement Too many surgical variables: What works?( SG; IT or DE?) Peculiar intraoperative complications(ischemia of the transposed segment) happen in a relatively high number Difficult operation, difficult pts, ~ 10,1 % major complications Reported mortality of 2.6% ( 0.28% RYGB) Better designed studies needed

Time Post Surgery (month) Time Post Surgery (month) R Cohen et.al SOARD, 2007 4 9 8 7 6 5 0 1 2 3 4 5 6 7 8 9 HbA 1c (%) 26 30 29 28 27 0 1 2 3 4 5 6 7 8 9 BMI (kg/m2)

Classic DJB We tested the hypothesis that bypassing the UGI tract with a DJB, without marked weight loss or restriction, may have a role on glucose homeostasis and beta cell function compared to a matched NGT group. Cohen R & Klein S ,2011

Results - 20% of all med free with A1c<6.5% @ 12 mo. - Significant decrease in med score @ 6 and 12 mo Cohen R & Klein S ,2011 Mean preop BMI 27.8 WL 6.9+- 4.9% @ 3mo Most returned to baseline @12mo. 5 gained weight x baseline

Delta BMI x A1c Delta BMI HAS NO IMPACT in the negative variation of A1c from preop to 12 months

Beta cell function T2DM x NGT T2DM x NGT Cohen R & Klein S ,2011

Conclusions Glycemic control not related to WL Improvement of beta cell function- all indices of responsiveness to glucose ingestion increased 2-3 fold after DJB It does not normalize beta cell function, but it has significant effects over it Klein S&Cohen R

Sleeve Gastrectomy + Duodenal Jejunal Bypass Non restrictive SG Pylorus preserving duodenal exclusion ( 100 cm biliary and 150 cm alimentary limbs

What’s behind those changes? The role of Ghrelin- direct and counter regulatory diabetogenic effects The role of the biliary limb lenght - bile acids induced incretin secretion (?)

Sleeved DJB or Short DS First 50 pts @ 18 mo Follow up Mean preop BMI = 28.9 TBWL 6.8% +- 3.7% 27 insulin users * 8 ( 16 %) pts with A1c less than 6 100 % between Control &Resolution Follow-up Mean A1c Insulin Unchanged Control, A1c<7 Less meds Resolution No meds,A1c<7 18 mo 6.2+-0.5* NONE 0 - NO 32% (16 pts) 68% (34 pts)

NO malabsortive component? 100% of non significant fecal fat detection

Hb A1c preop to 18 months - * p<0,05 8..9+-0.9 7.3+-0.4 6.8+-0.6 6.4+-0.5*

FPG preop to 18 months - * p<0,05 8..9+-0.9 7.3+-0.4 6.8+-0.6 6.4+-0.5*

Post prandial preop to 18 months - *p<0,05 8..9+-0.9 7.3+-0.4 6.8+-0.6 6.4+-0.5*

Other Metabolic Outcomes Significant decrease in CIT (0,71±0,16 preop to 0,61±0,13* 12 mo) Significant decrease in SBP and DBP Significant decrease in LDL and TG

Duodenal Jejunal Bypass Seems to be effective Diabetes resolution/improvement without direct relation to weight loss Low major complication’s rate (1.5%) Known and simpler operation - Duodenal switch with shorter limbs, minimized nutritional risks

We are not alone Biliopancreatic Diversion Preserving the Stomach and Pylorus in the Treatment of Hypercholesterolemia and Diabetes Type II: Results in the First 10 cases Giuseppe Noya , 1999, Obesity Surgery Excellent reported results, 7 “controlled”pts

We are not alone 1.9% major complication rate

DJB-literature 1.3% major complication rate Remission Improvement Remission and Improvement LSG+DJB 93% 7% 100%

DJB-literature Modest decrease in BMI, with decrease in A1c @ 6 mo

What is the role of Duodenal Exclusion Per se on diabetes? Is Duodenal Exclusion per se Antidiabetic?

De Paula’s CT COMPARED IT + SG x IT+SG+ Duod Exclusion( only variable)

Adding a duodenal exclusion improves results

• GI Bypass Surgery (Duodenal Exclusion) Repair of underlying pathophysiologic mechanisms of diabetes?

Why Sleeved DJB? X No gastric remnant No dumping Pylorus-preserving Well known Easier ? BETTER THAN RNYGB?

T2DM surgery in lower BMIs Although we believe that we have several SILENT EVIDENCES , that point us that surgery may benefit T2DM in lower BMIs, we need to start speaking NATIVE CONTEMPORARY DIABETOLESE! RANDOMIZED CONTROLLED TRIALS!!! RYGB x Sleeved DJBxBest Med treatment in BMIs 26-35 Work in Progress !! RYGBxSGX Best Med Treatment im=n BMIs 26-35

Opciones quirúrgicas válidas r cohen

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Opciones quirúrgicas válidas r cohen