C.S.T.O. Who Would Have Thought It? Banded Gastric Bypass Works! MAL Fobi MD FACS, FICS, FACN...

C.S.T.O.C.S.T.O.

Who Would Have Thought It? Banded Gastric Bypass Works!Who Would Have Thought It? Banded Gastric Bypass Works!

MAL Fobi MD FACS, FICS, FACN MAL Fobi MD FACS, FICS, FACN

Medical DirectorCenter for Surgical Treatment of

ObesityLong Beach CA, USA

C.S.T.O.C.S.T.O.

Banded Gastric Bypass

Disclosures

President of Bariatec Corporation. A device Compny

I had a Banded Gastric Bypass

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Obesity, particularly Morbid Obesity, is a life long disease that is recalcitrant to any treatment, even surgical treatment.

Obesity, particularly Morbid Obesity, is a life long disease that is recalcitrant to any treatment, even surgical treatment.

Why the Banded Gastric Bypass?Why the Banded Gastric Bypass?

Obesity: A World EpidemicObesity: A World Epidemic

The exact method of genetic translation is not known at this time. The

Expression of obesity varies with social, cultural, environmental, economic

and psychological influences.

The exact method of genetic translation is not known at this time. The

Expression of obesity varies with social, cultural, environmental, economic

and psychological influences.

EATING DIS.

EATING DIS. HORMONAL

HORMONALIMBALANCE

IMBALANCE

PSYCHO-PSYCHO-LOGICALLOGICAL

DIS.DIS.

SOCI

O-

SOCI

O-

ECOM

OM

ICS

ECOM

OM

ICS

WIL

L

WIL

L

POWER

POWER

GENETIGENETIC C

Obesity is a disease with a Genetic Predisposition

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ECONOMICECONOMIC

MEDICALMEDICAL

SOCIALSOCIAL

PSYCHOLOGICALPSYCHOLOGICAL

Significant ramifications of obesity

Significant ramifications of obesity

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• Prolonged and sustained weight loss has not bee proven with drug therapy.

*• Published studies of medical approaches to treatment of obesity

include few reports or indications of efficacy in person with clinically severe obesity.

*• Evidence of long-term efficacy of behavior modification in

persons with clinically severe obesity is lacking.*

• VLDC's used under close medical supervision generally have not been successful for achieving permanent weight loss.

• Prolonged and sustained weight loss has not bee proven with drug therapy.

*• Published studies of medical approaches to treatment of obesity

include few reports or indications of efficacy in person with clinically severe obesity.

*• Evidence of long-term efficacy of behavior modification in

persons with clinically severe obesity is lacking.*

• VLDC's used under close medical supervision generally have not been successful for achieving permanent weight loss.

NIH Consensus Statements 1991

NIH Consensus Statements 1991

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Gastric Bypass/Banded Gastric bypassGastroplasty/Sleeve GastrectomyGastric BandingBilio-pancreatic Diversion with or without a Switch

Intestinal Bypass

Gastric Bypass/Banded Gastric bypassGastroplasty/Sleeve GastrectomyGastric BandingBilio-pancreatic Diversion with or without a Switch

Intestinal Bypass

Surgical Treatment is the only treatment that provides effective long-term controlSurgical Treatment is the only treatment that provides effective long-term control

Surgical Treatment and Management of ObesitySurgical Treatment and Management of Obesity

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INTESTINAL BYPASS

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GASTRIC BYPASS

Simple operation???

•As effective

•Less morbidity

•Less mortality

Mason Gastroplasty 1971Mason Gastroplasty 1971

Evolution of the Gastric BypassEvolution of the Gastric Bypass

Linner’s Banded Gastric Bypass

1984


Salmon’s Banded Vertical Gastroplasty Distal

RYGBP1986


Banded Gastric Bypass Fobi Modification

1986

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Banded Gastric BypassBanded Gastric Bypass

VS

3-4cm

Howard, Obesity Surgery, 1995Howard, Obesity Surgery, 1995

VBG VS. GBPVBG VS. GBP

Howard, Obesity Surgery, 1995Howard, Obesity Surgery, 1995

VBG VS. GBPVBG VS. GBP

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0.0

38.0

57.0

73.578.2 77.7 76.8 75.0

73.2 72.3 71.0

69.8

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0

80.0

90.0

0M 3M 6M 1Y 2Y 3Y 4Y 5Y 6Y 7Y 8Y 9Y

TIME POST-OP

PE

WL

(%)

ALL PTS

Average PEWL (All Pts.) Banded Gastric Bypass

Average PEWL (All Pts.) Banded Gastric Bypass

FobiObes. Surg.2005

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Why the Banded Gastric Bypass

Why the Banded Gastric Bypass

Historical and Experimental Data:

•There are eight series with long term (6-14years) follow-up documenting 70+ PEWL and weight loss maintenance in more patients, even the old and super obese

• Capella, USA, AJS; Fobi, USA, SOARD; White, New Zealand, Obes Surg; Salinas, Venuzuela SOARD; D.Margo, Obes Surg; Mali, Obes Surg; Cruz, Obes Surg; and Awad, Obesity Surgery 2012

•There are only six long term series reported with the non-banded gastric bypass with an average of 55 PEWL, except Sutter with 70+ PEWL

• Pories, Sutter, Dinitz, Christou, Higa, and the Swedish study

Historical and Experimental Data:

•There are eight series with long term (6-14years) follow-up documenting 70+ PEWL and weight loss maintenance in more patients, even the old and super obese

• Capella, USA, AJS; Fobi, USA, SOARD; White, New Zealand, Obes Surg; Salinas, Venuzuela SOARD; D.Margo, Obes Surg; Mali, Obes Surg; Cruz, Obes Surg; and Awad, Obesity Surgery 2012

•There are only six long term series reported with the non-banded gastric bypass with an average of 55 PEWL, except Sutter with 70+ PEWL

• Pories, Sutter, Dinitz, Christou, Higa, and the Swedish study

83,5(45-115)

61,5(27-109)

Awad et al Obes. Surg.2012

Presented at IFSO_LAC Congress Cartagenia, Columbia, March 2011

There is a significative difference in %EWL at 36-96 month. We followed the banded patients for 10 and 12 years and they maintained the same %EWL.

% EWL% EWLBanded vs Non Banded Gastric Bypass

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Banded Gastric Bypass vs. Non-Banded Gastric Bypass Banded Gastric Bypass vs.

Non-Banded Gastric Bypass

Dr. LemmensIFSO Dehli2012

Retrospective Review

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Prospective comparative evaluation of the Laparoscopically banded gastricbypass vs. the Laparoscopically non-banded gastric bypass.

Banded GBP Non-Banded GBP (n= 20) (n=20)

BMI 58.7 51.18

Age (years) 46 47

6 months %EWL 43.1 38.6

12 months %EWL 64.0 57.800

36 months %EWL 67.6 55.7Complications %(n) 20%(5) 35%.(7)

% of patients achieving 50%EWL 85% 65%

BGBP vs. GBP BGBP vs. GBP

Fobi et al IFSO 2011 Hamburg Germany

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Prospective comparative evaluation of the Laparoscopically banded gastric bypass vs. the Laparoscopically non-banded gastric bypass in the super obese.

Banded GBP Non-Banded GBP (n=46) (n=44)

BMI 59.4 59.7

Age (years) 40.6 42.6

6 months %EWL 43.1 24.7

12 months %EWL 64.0 57.8

24 months %EWL 64.2 57.1

38 months %EWL 73.4 57.7Complications %(n) 23.9 (11) 29.5 (13)

% of patients achieving 50%EWL 63% 45%His conclusion: It appears the banded gastric bypass produces more weight loss in more patients

Marc Bressler, SOARD, July/August 2007

Banded Gastric Bypass VS. Non Banded Gastric Bypass. Banded Gastric Bypass VS. Non Banded Gastric Bypass.

Schauer and Associates at the Cleveland Clinic

•Presented Prospective Evaluation with two year follow-up at IFSO Congress in Hamburg (2011)

•Showed more weight loss and maintenance with the BGBP


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Karcz et al. GaBP Ring European multicenter clinical trials.

IFSO, Dehli 2012



Herrera, Mexico, SOARD 2009

•Prospective Evaluation with two years follow-up•Showed no difference


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Published reports of band placement in failed gastric bypass document increased weight loss and waight loss maintenance

• Bressler M. Obes Surg 2005;15:1443-48 • Kyzer S. Obes Surg 2001;11:66-9• Gobble RM. Surg Edosc. 2008;22:1019-22• Heath D. Obes Surg 2009;19:1439-41• Himpens Obes Surg 2001, 11(4):528-31• Avinoah E. obes surg 2006; 6:213-15


Adjustable Band Placement for Revision of failed Gastric Bypass

Adjustable Band Placement for Revision of failed Gastric Bypass

BresslerObes. Surg.2005

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“Since Roux-en-Y Gastric Bypass is primarily a restriction operation, just as with VBG, it is

important that the outlet of the pouch does not stretch.”

( E.Mason, Obesity Surgery 1994; 4:66-72)

“Since Roux-en-Y Gastric Bypass is primarily a restriction operation, just as with VBG, it is

important that the outlet of the pouch does not stretch.”

( E.Mason, Obesity Surgery 1994; 4:66-72)

Banding the Pouch in GBPBanding the Pouch in GBP

C.S.T.O.C.S.T.O.

At this time, the most promising technique based on a large series is that described by Capella and Capella, the “Banded Gastric Bypass”

At this time, the most promising technique based on a large series is that described by Capella and Capella, the “Banded Gastric Bypass”

MacLean, J Am Coll Surg 97; 185:1-7


• Fisher after an in depth review concluded that “Long-term results suggest that a silastic ring encircling the stomach pouch proximal to the gastroenterostomy may improve the outcome following gastric bypass surgery, resulting in more weight loss by a greater number of patients sustained for a longer time”- Fisher BL, Barber AE, Eur J Gatroenterol Hepatol 1999; 11:93-97

Why the Band in the Gastric Bypass Operation

Why the Band in the Gastric Bypass Operation

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(* P < 0.05).

[O’Brien P.E.:Systemic review of mdium term-weight loss after bariatric surgery.; Obesity Surgery:2006; 16; 1032-40]

%EWL for standard RYGBP and its two hybrid forms of LL-RYGBP

and Banded RYGBP

%EWL for standard RYGBP and its two hybrid forms of LL-RYGBP

and Banded RYGBP

Banded Gastric Bypass Banded Gastric Bypass

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Reservoir sizeReservoir size

change with change with timetime

Non-banded Roux-en-Y GBPNon-banded Roux-en-Y GBP

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Non-banded Roux-en-Y GBPNon-banded Roux-en-Y GBP

C.S.T.O.C.S.T.O.

Reservoir sizeReservoir size

change with change with timetime

Banded Roux-en-Y GBPBanded Roux-en-Y GBP

C.S.T.O.C.S.T.O.


Ring Banded Gastric Bypass

Stubbs, Obes Surg; 2005

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Optimal Ring Size6.5 cm 2.07cm Diameter1.47cm functional diameter.

3-D Recon Image of Ring Banded Gastric Bypass

Mohit BhandariIndore, India 2012

French Catheter Size1 Fr. = 1/3 mm diameter34 Fr. = 1.13cm diameter40 Fr. = 1.33cm diameter60 Fr. = 2.0cm diameter

Ring or bandshould be loosearound the pouchat time of banding

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Band erosion: - 0-7%. Incident directly related totype of the device used, the diameter and size of the device and thepresence of contamination or infection.

Ring sizes < 6.5cm cause more erosion and dysphagiawithout increase in effectiveness.

Kinking or Slippage: - - 0-1%. Functional ObstructionTreated by endoscopic dilatation or laparoscopic re exploration

Solid Food intolerance: - 5-7 %. Not disabling.Treated by dietary counseling.Occasional need for Ring removal

Complications from Banding the Gastric Bypass



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Surgeons have used various devices to band the pouch

Surgeon fashioned devices

Marlex Mesh

Silastic Tubing

Ethibond Suture

Linea Alba Fascia

Porchine Graft

Bovine Graft

Commercially prefabricated devices

GaBP Ring. (Designed for use with the gastric bypass and sleeve gastrectomy)

IOC Band

AMI Band

Minimizer Band

Bioring

GaBP Ring Autolock™ and Gastrostomy Site Marker Clinical Research Study ProtocolIDE G050231

IPERSONNEL ---------------------------------------------------------------------------------------------------------2IISTUDY SYNOPSIS --------------------------------------------------------------------------------------------------3IIICLINICAL TRIAL --------------------------------------------------------------------------------------------------51.Introduction and Rationale -----------------------------------------------------------------------------------52.Study Objective ------------------------------------------------------------------------------------------------62.1Effectiveness Endpoints -----------------------------------------------------------------------------62.2Safety Endpoints --------------------------------------------------------------------------------------63.Study Design --------------------------------------------------------------------------------------------------74.Patient Population ---------------------------------------------------------------------------------------------84.1Exclusion Criteria -------------------------------------------------------------------------------------84.2Inclusion Criteria --------------------------------------------------------------------------------------95.Device Characterization -------------------------------------------------------------------------------------95.1Intended Use and Description ------------------------------------------------------------------------96.Study Methods -------------------------------------------------------------------------------------------------106.1Patient Entry and Pre-operative Evaluation -------------------------------------------------------106.2Device Installation and Intra-operative Evaluation -----------------------------------------------116.3Post-operative Care -----------------------------------------------------------------------------------116.4Post-operative Evaluation ----------------------------------------------------------------------------117.Study Procedures ----------------------------------------------------------------------------------------------138.Data Monitoring -----------------------------------------------------------------------------------------------138.1Data Reporting and Monitoring Procedures -------------------------------------------------------138.2Adverse Reaction and Adverse Event Reporting -------------------------------------------------159.Study Analysis -------------------------------------------------------------------------------------------------159.1Sample Sizes -------------------------------------------------------------------------------------------159.2Statistical Methods ------------------------------------------------------------------------------------1510.Bibliography --------------------------------------------------------------------------------------------------16IVAPPENDICES -------------------------------------------------------------------------------------------------------17Appendix 1:Consent to Act as a Human Research Subject -------------------------------------------------17Appendix 2:Device Design and Labeling --------------------------------------------------------------------27Appendix 3:Prior Clinical Investigations --------------------------------------------------------------------44Appendix 4:Surgical Procedure ------------------------------------------------------------------------------50Appendix 5:Device Removal Indications and Procedures --------------------------------------------------57Appendix 6:Examination Procedures, Study Equipment and Techniques -------------------------------58Appendix 7:Sponsor’s Commitments -------------------------------------------------------------------------60Appendix 8:Investigator’s Qualifications and Responsibilities -------------------------------------------61Appendix 9:Investigator’s Agreement ------------------------------------------------------------------------62Appendix 10:Investigator’s Financial Disclosure Declaration ---------------------------------------------65Appendix 11:Declaration of Helsinki/Protection of Human Subjects/Belmont Report/Institutional Review Board --------------------------------------------------------------------------------------66Appendix 12: Physician Information Letter --------------------------------------------------------------------96Appendix 13:Case Report Forms -------------------------------------------------------------------------------105

GaBP RingTM DeviceGaBP RingTM Device

GaBP Ring™ is a prefabricated, sterilized ring designed to band the proximal pouch of the sleeve gastrectomy and gastric bypass operations.

GaBP RingTM DeviceGaBP RingTM Device

Banded Gastric Bypass3,632 (100 %)

Primary3007

( 82.79 %)

Secondary405

( 11.15 %)

Revision220

( 6.06 %)

Band Erosion57 ( 1.89 %)

Band Erosion24 ( 5.92 %)

Band Erosion10 ( 4.54%)

Total Incidence of Band Erosion:91/ 3,632 (2.5 %)

Total Incidence of Band Erosion:91/ 3,632 (2.5 %)

Incidence of Band Erosion(May 1992 – May 2002)

Incidence of Band Erosion(May 1992 – May 2002)

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C.S.T.O.C.S.T.O.



Dr. LemmensIFSO Dehli2012

Retrospective Review

C.S.T.O.C.S.T.O.

Karcz et al. GaBP Ring European multicenter clinical trials.

IFSO, Dehli 2012



C.S.T.O.C.S.T.O.

1. Outlet Stenosis/vomiting/dysphagia

2. Stomal Ulcer/ pain/bleeding/melana

3. Pain, epigastric and or left shoulder

4. UGI Bleeding

5. Acute weight loss followed by

weight regain.

1. Outlet Stenosis/vomiting/dysphagia

2. Stomal Ulcer/ pain/bleeding/melana

3. Pain, epigastric and or left shoulder

4. UGI Bleeding

5. Acute weight loss followed by

weight regain.

Symptoms of Band ErosionSymptoms of Band Erosion

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1 - Expectant treatment- spontaneous extrusion

2 - Endoscopic removal

3 - Surgical Removal with revision. Band replacement vs. addition of mal absorption component

1 - Expectant treatment- spontaneous extrusion

2 - Endoscopic removal

3 - Surgical Removal with revision. Band replacement vs. addition of mal absorption component

Treatment of Band ErosionTreatment of Band Erosion

Endoscopic RemovalEndoscopic Removal

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Outlet Stenosis Requiring Dilatation

GBP 1-16%

BGBP 1-3%

Outlet Stenosis Requiring Dilatation

GBP 1-16%

BGBP 1-3%


C.S.T.O.C.S.T.O.

Reactive Hypoglycemia:

-Observed in patients with Band removal or band erosion.

Fobi et al. Presentation at OSSICON, 2004

-Treated with ring placement Kasper Z’Graggen. Obes Surg, 2008

Reactive Hypoglycemia:

-Observed in patients with Band removal or band erosion.

Fobi et al. Presentation at OSSICON, 2004

-Treated with ring placement Kasper Z’Graggen. Obes Surg, 2008


C.S.T.O.C.S.T.O.

CONCLUSION:

There is enough evidence that:“The banding the Gastric Bypass to standardize the restrictive effect:

• results in more weight loss• results in weight loss in more patients

even the super obese and • results in better weight loss maintenance”

CONCLUSION:

There is enough evidence that:“The banding the Gastric Bypass to standardize the restrictive effect:

• results in more weight loss• results in weight loss in more patients

even the super obese and • results in better weight loss maintenance”


C.S.T.O.C.S.T.O.

CONCLUSION:

There is evidence that banding the

gastric bypass also results in less

incidence of:

• outlet stenosis requiring dilatation,

• dumping syndrome

• reactive hypoglycemia

CONCLUSION:

There is evidence that banding the

gastric bypass also results in less

incidence of:

• outlet stenosis requiring dilatation,

• dumping syndrome

• reactive hypoglycemia


C.S.T.O.C.S.T.O.

BANDED GASTRIC BYPASS • Is an operation with weight loss outcome similar if not

better than the BPD and the Duodenal Switch operations without the associated metabolic consequences and complications?

• 1-7% Incidence of Band related complication is

observed.(erosion, slippage, obstruction, infection, and device coming apart)

BANDED GASTRIC BYPASS • Is an operation with weight loss outcome similar if not

better than the BPD and the Duodenal Switch operations without the associated metabolic consequences and complications?

• 1-7% Incidence of Band related complication is

observed.(erosion, slippage, obstruction, infection, and device coming apart)


Felipe De La Cruz, Handbook of Obesity Surgery, FD- Communications Inc 2010

C.S.T.O.C.S.T.O.

Who would Have Thought It?

Banded Gastric Bypass Works!


Center for Surgical Treatment of Obesity MAL Fobi MD FASMBS, FACS FICS, FACN.

www.bariatec.comwww.fobipouch.com

Center for Surgical Treatment of Obesity MAL Fobi MD FASMBS, FACS FICS, FACN.

www.bariatec.comwww.fobipouch.com

Thank You

Obrigado

MerciGracias

Merushi

Grazie

Dankeschön

C.S.T.O.C.S.T.O.

Hand Sewn Gastro-jejunostomy distal to GaBP Ring


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Ring placement forces use of a small tubular pouch with a standard stoma

C.S.T.O. Who Would Have Thought It? Banded Gastric Bypass Works! MAL Fobi MD FACS, FICS, FACN...

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