Gastric Bypass:Continuing Issues

Walter J. Pories, MD, FACSProfessor of Surgery, Biochemistry, Sport

and Exercise ScienceBrody School of MedicineEast Carolina University

Disclosures

• Grant support– NIH– Johnson & Johnson, Ethicon EndoSurgery– Glaxo Smith Kline– HRSA– Brody Brothers Foundation– Golden LEAF Foundation

• Surgical Review Corporation: Board of Directors

Gastric Bypass: A Summary• RYGB is a safe and effective operation• Durable remission of diabetes, hypertension, NASH,

GERD and other co-morbidities of severe obesity• Lowers morbidity and mortality rates• High rates of patient satisfaction• Long-term follow-up is required–Nutritional problems– Internal hernias–Psychologic challenges

Issue #1: What is a Gastric Bypass?

A lack of standardization makes comparisons difficult• Open? Laparoscopic? NOTES?• Gastric pouch: size? Vertical? horizontal?• Gastro-jejunostomy: hand sewn? Stapler: circular? or

linear?• Antecolic? retrocolic?• Length alimentary limb?• Length bilio-pancreatic limb?• Jejuno-jejunostomy: size? Stapled? Hand sewn?

Issue #1: What is a Gastric Bypass?

A lack of standardization makes comparisons difficult

• 16 variables: 131,072 variations ---difficult to defend

• Suggestion: • ASMBS Committee consider developing 3 – 4

standard models• Voluntary participation by surgeons• Assessment by BOLD

Issue #2: Should we settle for an 80% remission rate of T2DM after RYGB?• Observation: Remission rates of diabetes

following gastric bypass are lower in older patients and those who have had diabetes longer

A d j u s t a b l e G a s t r i cB a n d

G a s t r i cB y p a s s

D u o d e n a lS w i t c h

G a s t r i cS l e e v e

Is the 80.3% Remission Rate after RYGB limited by the destruction of the islets?

All articles in English, 1990 – 2006, 621 studies, 888 treatment arms, 135,246 patients

Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge, I. Meta-analysis of Bariatric Surgery and Diabetes, Am J Med (2009)122: 248 - 256

XS WT Loss 46.2% 57.9% ? 60% 63.6%Stop T2DM 56.7% 80.3% ? 60% 95.1%

A d j u s t a b l e G a s t r i cB a n d

G a s t r i cB y p a s s

D u o d e n a lS w i t c h

G a s t r i cS l e e v e

Is the 80.3% Remission Rate after RYGB limited by the destruction of the islets?

All articles in English, 1990 – 2006, 621 studies, 888 treatment arms, 135,246 patients

Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge, I. Meta-analysis of Bariatric Surgery and Diabetes, Am J Med (2009)122: 248 - 256

XS WT Loss 46.2% 57.9% ? 60% 63.6%Stop T2DM 56.7% 80.3% ? 60% 95.1%

Is the 20% failure rate

really due to exhaustion of

the islets?

A d j u s t a b l e G a s t r i cB a n d

G a s t r i cB y p a s s

D u o d e n a lS w i t c h

G a s t r i cS l e e v e

Is the 80.3% Remission Rate after RYGB limited by the destruction of the islets?

All articles in English, 1990 – 2006, 621 studies, 888 treatment arms, 135,246 patients

Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge, I. Meta-analysis of Bariatric Surgery and Diabetes, Am J Med (2009)122: 248 - 256

XS WT Loss 46.2% 57.9% ? 60% 63.6%Stop T2DM 56.7% 80.3% ? 60% 95.1%

A d j u s t a b l e G a s t r i cB a n d

G a s t r i cB y p a s s

D u o d e n a lS w i t c h

G a s t r i cS l e e v e

Is the 80.3% Remission Rate after RYGB limited by the destruction of the islets?

All articles in English, 1990 – 2006, 621 studies, 888 treatment arms, 135,246 patients

Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge, I. Meta-analysis of Bariatric Surgery and Diabetes, Am J Med (2009)122: 248 - 256

XS WT Loss 46.2% 57.9% ? 60% 63.6%Stop T2DM 56.7% 80.3% ? 60% 95.1%

No, actually, insulin

levels are high even in

advanced disease. The

islets are damaged but

able to respond

adequately.

A d j u s t a b l e G a s t r i cB a n d

G a s t r i cB y p a s s

D u o d e n a lS w i t c h

G a s t r i cS l e e v e

Is the 80.3% Remission Rate after RYGB limited by the destruction of the islets?

All articles in English, 1990 – 2006, 621 studies, 888 treatment arms, 135,246 patients

Buchwald H, Estok R, Fahrbach K, Banel D, Jensen MD, Pories WJ, Bantle JP, Sledge, I. Meta-analysis of Bariatric Surgery and Diabetes, Am J Med (2009)122: 248 - 256

XS WT Loss 46.2% 57.9% ? 60% 63.6%Stop T2DM 56.7% 80.3% ? 60% 95.1%

The rate of remission is “dose related”

to the exclusion of food from the gut.

To Rx advanced T2DM, more radical

Operations are needed.

Issue # 2: Is it time to consider adjusting bariatric surgery to our patients?

• Bands: BMI > 30 Moderate weight loss, few co-morbidities

• RYGB: BMI >35 with major co-morbidities• Duodenal Switch: Patients with diabetes who

are older, on insulin or had diabetes over eight years

• Perhaps BOLD might help us define the guidelines

Issue # 3: How long will we accept that our patients do not have access to the only effective therapy?

(*BMI ≥30, or ~ 30 lbs. overweight for 5’ 4” person)

No Data <10% 10%–14% 15%–19% 20%–24% 25%–29% ≥30%

Time to Change Strategies

• 39.8 million Americans are obese (BMI > 30• 15 million are severely obese (BMI > 35)• Bariatric operations in 2009: 180,000• 180,000/15,000,000 = 0.12%• What if we had a pill that could reverse

diabetes, severe obesity, crippling arthritis, etc.• Would 99.8% of the population accept denial?

Time to Change Strategies

• Educate the primary care colleagues?• Educate the endocrinologists?• Educate the carriers?• Educate Medicare and Medicaid?• Get real: They all know; they are threatened• Get real: none have much to gain• The common complaint:–No randomized, prospective clinical trials

Randomized, prospective trials are not required for proof of concept:

Where are the randomized, clinical trials of insulin vs. no insulin?

Oral

Should an IRB approve randomization between an effective proven therapy (RYGB)

vs. medical therapy?

Ethics of a randomized clinical trial:

Time to Change Strategies

• The demand for bariatric surgery will only increase when patients and their families become aware that they do not have to accept the ADA’s motto:

• “Living with Diabetes”• It’s time to let the patients know they are being

denied life-saving care, that they can live without diabetes.

• NOW!!