BPD-DS & Sleeve Gastrectomy Journal Club Goal: To review 4 important and clinically relevant papers from 2010 on BPD-DS or Sleeve Gastrectomy 4 papers; x4 min each

Article #1 British Journal of Surgery 2010;97(2):

Background Long-term follow-up studies of super-obese patients (BMI >50) have shown high weight loss failure rates following RYGB. Lap. BPD with duodenal switch (LDS): – Surgical option for super-obesity – But …. technically more complex & higher nutritional complications Operative safety, weight loss and long-term complications of the two procedures have not been evaluated in a randomized trial.

Aim To conduct a prospective, 2-centre randomized trial, comparing LRYGB vs. LDS for super-obese patients Endpoints Primary: Weight loss (at 1 yr) Secondary: Early (< 30 days) & late (up to 1 yr) complications, changes in body composition, co- morbidities, nutritional status & quality of life

Methods 2 centers, equally high volume units: 1.Oslo University Hospital 2.Sahlgrenska University Hospital, Gothenburg Inclusion criteria: – BMI kg/m 2, Age years Exclusion criteria – Previous bariatric or major abdominal surgery – Severe cardiopulmonary disease, malignancy, steroids, substance abuse or psych. illness All patients underwent same pre-op preparation incl kcal/day diet x3 weeks. Same peri-op routine for all (anesthesia, analgesia, fluid management)

Methods Patients randomized to LRYGB or LDS (stratified acc to surgical centre, sex, age & BMI) Results of randomization known only doctors enrolling patients, and schedulers. Patients informed 1 wk prior to procedure LRYGB: linear staplers, 25 ml pouch, antecolic antegastric gastrojejunostomy, 150cm alimentary limb LDS: Sleeve gastrectomy (30-32F), duodenum transected 4cm distal to pylorus, 200cm alimentary limb, 100cm common channel Post-op follow-up with surgeon & dietician: – 6 weeks, 6 months, 1 year – LRGYB patients prescribed additional vitamin B12

Results CONSORT diagram

Results

Peri-operative results (<30 days ) No mortality Mean (SD) operative time: – LRYGB:91 (33) min – LDS:206 (47) min ….. (p<0.001) Conversion rates: 1 LDS procedure, 0 LRYGB Complications: – LRYGB n=4 – LDS n=7.…. (p=0.327) Median (range) LOS – LRYGB 2 (2-15) days – LDS 4 (2-43) days.…. (p<0.001)

Results

Late complications: – LRYGB: n=4 – LDS:n=9 ….. p=0.121 Severe metabolic effects: – LRYGB:n=0 – LDS:n=2 (Hypoalbuminemia, iron def)

Results Weight loss:

Discussion Inexperience with procedure High complication rate with bypass Long term follow up

Conclusion Large difference in BMI at 1 year (6 kg/m 2 lower in LDS group), and stability of weight loss after DS shown by other groups, suggest that LDS is better at promoting short- and long-term weight loss in super-obese patients

Article #2 Biertho et al, SOARD 2010;6(5):

Background Of all bariatric procedures, DS known to offer some of the best long-term weight loss results Usually reserved for super-obese (BMI >50) because of increased risk of nutritional complications Safety and efficacy of DS in patients with BMI<50 have not been well established …… as a primary procedure, or a secondary procedure in patients who have reduced their BMI to <50

Aim To determine safety & efficacy of DS as a primary weight loss procedure in patients with BMI < 50 kg/m 2

Methods 810 consecutive patients, all with BMI <50 kg/m 2, underwent DS at single institution from June 1992 to May 2005 All procedures performed open – 250-cm 3 sleeve gastrectomy created – Duodenum transected about 4 cm distal to the pylorus and anastomosed to a 250-cm alimentary limb, with a 100-cm common channel. – Routine cholecystectomy and appendectomy

Methods Follow-up: – Patients usually seen at 3, 6, 9, and 12 months postoperatively. Thereafter, annual review (clinical & biochemical data collected) – Determined patient satisfaction every 5 years via mailed questionnaire

Results 810 consecutive patients – 637 women (78.6%) – Mean age:41.1 years – Mean preop BMI:44.2 kg/m 2 (Range 33-49) – Comorbidities: DM28% (n=227) Hypertension37% Sleep apnea25% – Mean follow-up:103 months (Range ) – Mean hospital stay:6.9 ± 5.4 days

Results Complications: Intra-op: 0.7% (n=7) – Liver laceration (1) – Splenic injuries (6) Major post-op: 4.9% (n=40) – 5 operative deaths (<30 days) Minor complications: 8% (n=66) – Wound infections – Resp infections – Intestinal disturbance * * * *

Results Long-term outcomes Weight loss: – At mean of 8.6 years: EWL 76% ± 22.3% Only 11% had EWL <50% BMI was <35 in 92%, and < 30 in 71%

Results Comorbidity status postoperatively: – DM:92.5% ‘cured’ (requiring no medications) – Hypertension:60% no longer requiring anti-hypertensives – Sleep apnea:Only 2% still require an apparatus Patient satisfaction 63% very satisfied with weight loss 91% very satisfied with overall outcome

Results Long-term complications – Rehospitalization required in 15.8% (n=127)

Results Long-term complications – Nutritional status Albumin: ↓ significantly postop – (41.6mg/dL preop to 40.7 mg/dL postop, p<0.001) – Severe hypoalbuminemia (<30mg/dL): 0.6% preop and in 1.1% postop (p=0.5) Anemia: more prevalent postoperatively – 0.1% vs. 1.6%, p=0.006 Vitamin A and Calcium deficiencies also more prevalent postoperatively (p=0.04 and p=0.0009, respectively) Long-term mortality rate 3% (n=25) 2 deaths related to bariatric surgery …. One at 18 months (malnutrition), another 3 years post DS (intestinal obstruction)

Discussion Significant decreases in albumin, hemoglobin, folic acid, B12 calcium Complication rate is significant Why < 5% of surgeries

Conclusion DS is highly efficient in terms of weight loss in non super-obese patients, bringing great satisfaction to patients Long-term risks of malnutrition and nutritional deficiencies exist, but are usually manageable with medical treatment & only seldom require reoperation

10/12/2015 Ann of Surg, 248, 5, Nov Article #3 Annals of Surgery 2010;252(2):

Study Overview Laparoscopic sleeve gastrectomy (LSG) was originally intended as a bridging procedure for super obese patients awaiting definitive bariatric intervention. After early promising results, sleeve gastrectomy was proposed as a potential definitive treatment for morbid obesity Long-term efficacy of LSG remains to be determined

Aim To determine mid- and long-term efficacy (6 years results), and possible side effects of LSG as a treatment for morbid obesity

Methods 53 patients underwent LSG between Nov 2001 & Oct 2002 Inclusion criteria: – NIH guidelines for bariatric surgery – Restrictive procedure chosen according to an institutional algorithm 1 Follow-up: – Regular follow-up until 3 years postoperatively – Telephone questionnaire administered on 6 th postop year LSG procedure: – 34 F bougie, antrum spared 1 Cadière GB et al. Atlas of Laparoscopic Obesity Surgery 2007.

Methods Outcomes measured: – Weight loss (change in BMI and %EWL) – Adverse events – Quality of Life (determined using BAROS score^) ^ Bariatric Analysis And Reporting Outcome System score

Results Patient characteristics – Complete 6 yr data available in 78% (n=41) – 73% female, median age 44 years (Range 28-71) – Median preop BMI 39.0 kg/m 2 (31-57) – Comorbidities: 1 patient with DM 5 with hypertension 1 patient with GERD 11 of the 41 patients underwent a 2 nd stage DS for weight regain, between 3-6 yrs post LSG. 2 other patients underwent a ‘re-sleeve’ operation Subgroup analysis performed

Results Efficacy EWL at 3 years 72.8%, and at 6 years 57.3%

Results

Comorbidity status – The single diabetic pt had resolution of the disease – Hypertension resolved in 2 of 5 Quality of life – 43.4% (23 of original 53 patients) were either lost to follow-up, refused to respond to questionnaire, or needed another procedure …. All were considered ‘dissatisfied’ with LSG – Median BAROS score after 6 yrs was 5 (range 2-9)

Results Failure rate – Patients who did not achieve 50% EWL, & those 23 who were unavailable for follow-up or needed a 2 nd operation, were considered failures. – At 3 yrs: 47% – At 6 yrs:64% Postoperative morbidity – Major: 12.2% (n=5) Leak (2), stenosis (1), bleeding (1), incisional hernia (1) – GERD reported by 26% (overall group) at 6 yrs – No surgery related mortality 1 death from colon ca 4 yrs post LSG

Discussion Discussion about “neo fundus” and grehlin is interesting but speculative Weight regain is actually under reported by ”intention to treat” definition

Conclusions LSG is a safe, effective, and well accepted bariatric procedure But appears to be associated with weight regain, & quite often associated with GERD symptoms, in longer term follow-up Weight regain but not GERD may be managed by a completion DS procedure after LSG

10/12/2015 Ann of Surg, 248, 5, Nov Article #4 Surgery 2010;147(5):

Study Overview Laparoscopic sleeve gastrectomy (LSG) is emerging as a promising therapy for the treatment of obesity and T2DM LSG has been shown to produce better weight loss than gastric banding, and seems to be less invasive than gastric bypass with comparative outcomes. Therefore, LSG has been proposed as the recommended bariatric procedure for lower BMIs Mechanisms accounting for beneficial effects of LSG on glucose homeostasis are not well understood and remain speculative

Aims To assess the efficacy of LSG for T2DM treatment in non-severely obese subjects with poorly controlled diabetes under current medical treatment

Methods 20 Asians with T2DM underwent LSG – Female 70% – Mean preop BMI31.0 (±2.9) kg/m 2 – Mean age 46.3 (±8.0) years – Mean HbA1C 10.1 (±2.2) % Inclusion criteria: – years old – T2DM for 6 months, poorly controlled (A1C>7.5%) – BMI kg/m 2 – C-peptide >1ng/mL – No irreversible major organ damage related to DM

Methods Serial measurements of insulin secretion using OGTT; at 1, 4, 12, 26, 52 wks postop Early insulin secretory response to a specific glycemic response was measured by the ‘insulinogenic index’ Resolution of DM defined as: – Fasting glucose < 126mg/dL, & A1C<6.5% – Without use of oral hypoglycemics or insulin ∆ Insulin ∆ Glucose ….. at 30 min during OGTT

Results N=20 All pts on multiple medications 4 taking Insulin (20%) Mean op time 127 min (75-140) Mean LOS 2.1 days (1-5) No major complications

Results

DM remission postop: – 1 wk0% – 4 wks 20% – 12 wks 30% – 26 wks 40% – 52 wks 50% Mean HbA1C reduction at 52 wks: 3.0%

Results Insulin secretion during OGTT Preop: typical delayed insulin secretion Normal insulin peak at 30 min

Results AUC (uIU.min/mL) Preop 3,135 1 wk 2,989 4 wks 2, wks 1, wks 3, wks 3,351 Insulinogenic Index Preop wk wks wks wks wks 0.2 ∆ Insulin ∆ Glucose ….. at 30 min during OGTT * No significant difference compared to preop AUC * * * Significantly higher compared to preop index * * *

Results C-peptide (ng/ml) ↓ postop Preop3.3 1 wk1.7 4 wks wks wks wks1.6 DM remission & C-peptide: C-peptide <3:1/7 remitted C-peptide 3-6:7/11 remitted C-peptide >6:2/2 remitted …… p<0.05

Discussion Not any significant conclusions as no gut hormones were measured (neither was gastric emptying) No control groups

Conclusions LSG resulted in DM remission in up to 50% of non- morbidly obese poorly controlled T2DM patients at 1 year. The mechanism was associated with a decrease in insulin resistance, and an increase in early insulin response, rather than with an increase in total insulin secretion C-peptide >3 ng/mL appeared to be the most important predictor for a successful treatment.

Other papers of interest BPD-DS & Sleeve Gastrectomy

Marceau et al, Obes Surg 2010;20(12):

Prachand et al, J Gastrointest Surg 2010;14(2):