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![Page 1: Ninh T. Nguyen, MD Professor of Surgery Division of GI Surgery University of California, Irvine Medical Center Gastric Plication: Is it Ready for Prime.](https://reader036.fdocuments.net/reader036/viewer/2022062321/56649e875503460f94b8bc4e/html5/thumbnails/1.jpg)
Ninh T. Nguyen, MDProfessor of Surgery
Division of GI Surgery
University of California, Irvine Medical Center
Gastric Plication: Is it Ready for Prime Time? Con
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Disclosure SlideDisclosure Slide
Ninh T. Nguyen
Covidien Grant/speakerGore SpeakerSurgiquest ConsultantEthicon Speaker
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Why Gastric Plication is not Ready for Prime Time!
• Lack of scientific rationale
• Lack of data
• No evidence for metabolic effect
• Not recognized by ASMBS
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Why Gastric Plication is not Ready for Prime Time!
• Lack of scientific rationale
• Lack of data
• No evidence for metabolic effect
• Not recognized by ASMBS
![Page 5: Ninh T. Nguyen, MD Professor of Surgery Division of GI Surgery University of California, Irvine Medical Center Gastric Plication: Is it Ready for Prime.](https://reader036.fdocuments.net/reader036/viewer/2022062321/56649e875503460f94b8bc4e/html5/thumbnails/5.jpg)
Rationale for Gastric Plication?
• Improve weight loss and resolution of comorbidities?
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Rationale for Gastric Plication?
• Minimize complication associated with sleeve gastrectomy
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Rationale for Gastric Plication?
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Complications of Sleeve Gastrectomy
• Bleeding
• Leaks
• Obstruction
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Complications after Gastric Plication
• 135 pts underwent LGCP
• GI bleeding (1.5%)
• leaks (1.5%)
• Acute gastric obstruction (2.2%)
Skrekas et al. Obes Surg 2011
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Complications after Gastric Plication
• 100 pts underwent LGCP
• 3 yr, 57% EWL (n=11) for GCP
• Obstruction requiring reop (1%)
• Leaks (2%)
Talebpour et al. J Laparoendosc Adv Surg Tech 2007
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Complications after Gastric Plication
• 15 pts underwent LGCP
• 1 yr, 53% EWL (n=6) for GCP
• Acute gastric obstruction requiring reop (16.6%)
Brethauer et al. SOARD 2011
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Ideal Bariatric Operation
• Low morbidity & low mortality (risks)
• Good efficacy (benefits)
• Reproducible
• Low revisional rate
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Issues with Gastric Plication for Widespread Acceptance
• Variability in technique & not easily reproducible- Small margin for error (too small vs too large)
• Doesn’t appear to reduces perioperative complications
• Complicated for revisional
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Why Gastric Plication is not Ready for Prime Time!
• Lack of scientific rationale
• Lack of data
• No evidence for metabolic effect
• Not recognized by ASMBS
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Accumulating Data
• Perform under institutional IRB
• Courses on procedure should only be held specifically for investigators planning to participate in a multicenter trials of the new procedure
• Publish data for peer-review
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Sleeve Gastrectomy as bariatric ProcedureCIC of ASMBS
• First stage to reduce surgical risk
• 775 patients (15 reports)
• Single study with 3-year follow-up
• %EWL 33-83%, mortality: 0.39%
• The ASMBS recognizes sleeve may be an option for selected patients, particularly high-risk or super obese as a risk reduction strategy
SOARD 2007
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Updated Position Statement on Sleeve Gastrectomy as bariatric Procedure
• Overall 36 studies (2570 patients) - Primary procedure, 24 studies (1749 patients)
• For primary procedure, follow-up 3-36 mos., 60.6% EWL
• Conclusions:- Long-term data remain limited- ASMBS accepted SG as an approved bariatric procedure as a first stage for high-risk patients and possible obviate the need for a 2nd stage
SOARD 2010
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Is another Operation Needed to Improve to Outcomes of Sleeve?
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International Sleeve Gastrectomy Expert Panel Consensus Statement
Best Practice Guidelines Based on Experience of Over 12,000 Cases
Surgery for Obesity & Related Diseases. 8(1):8-19, 2012 Jan doi:10.1016/j.soard.2011.10.019
19
DSL#12-0041
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2011 INTERNATIONAL SLEEVE GASTRECTOMY EXPERT CONSENSUS
AUTHORS/PANEL EXPERTS
a Conference Chairman and Statement primary authorb Conference Co-Chairman
20
Surg Obes Relat Dis 8(1):8-19, 2012 Jan.
Aceves Alberto Mexico Jossart Gregg US
Arvidsson Dag Sweden Lakdawala Muffazal b India
Baker S. Randal US Mourad Haicam El Belgium
Basso Nicola Italy Nguyen Ninh T US
Bellanger Drake US Nocca David France
Boza Camilo Chile Pomp Alfons US
France Michael Australia Prager Gerhard Austria
Gagner Michel US Ramos Almino b Brazil
Galvao‐Neto Manoel Brazil Rosenthal Raul J a US
Higa Kelvin D US Shah Shashank India
Himpens Jacques b Belgium Vix Michel France
Jacobs Moises US Wittgrove Alan US
Jorgensen John O Australia Zundel Natan US/Colombia
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COLLECTIVE OUTCOMES DATA
In their sleeve gastrectomy practice: Preoperative age: 42 ± 3.8* years Preoperative BMI: 44 ± 4.5* Approximately 3 of every 4 are women Length of hospital stay: 2.5 ± 0.9* days. Only about 1 ± 2* % converted to open 1 ± 1* % leaks, <1% strictures, and 12 ± 9.0* %
GERD postoperatively.
21
Surg Obes Relat Dis 8(1):8-19, 2012 Jan.
* Mean and Standard Deviation
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Reduces Leaks or Improve Management of Leaks or Both
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Sleeve Complication
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Endoscopic Management of Sleeve Leaks
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Why Gastric Plication is not Ready for Prime Time!
• Lack of scientific rationale
• Lack of data
• No evidence for metabolic effect
• Not recognized by ASMBS
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Mechanisms of Sleeve gastrectomy
• Restriction
• Neurohormonal changes - Ghrelin- PYY- GLP-1
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First-phase insulin secretion, insulin sensitivity, ghrelin, GLP-1, and PYY changes 72 h after sleeve gastrectomy in
obese diabetic patients: the gastric hypothesis
• Insulin secretion and peripheral insulin sensitivity using the IVGTT were assessed in 18 obese type 2 diabetic and in 10 nondiabetic obese patients before and 3 days after SG
• In diabetic patients with disease less than 10.5 years, the first phase of insulin secretion promptly improved after SG, indicating an increased glucose-induced insulin secretion. The second phase of insulin secretion (late AUC) significantly decreased after SG in all groups, indicating an improved insulin peripheral sensitivity. In all groups, pre- and postoperatively, IVGTT determined a decrease in ghrelin values and an increase in GLP-1 and PYY values.
Basso et al. Surg Endosc 2011
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Why Gastric Plication is not Ready for Prime Time!
• Lack of scientific rationale
• Lack of data
• No evidence for metabolic effect
• Not recognized by ASMBS
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Surgeon & Innovation
Operation Technique Device Indications
Low BMI
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Why Systematic Process is Needed?
• Protection of patients
• Protection of our field
• Protection of the surgeon
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Systematic Pathway for Recognzing a New Bariatric Operation
• FDA approval
• Accumulate substantial peer-reviewed data demonstrating its safety & short and medium-term efficacy
• Recognized by ASMBS
• Obtaining coverage for the procedure
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Recognition by ASMBS• Statement development by the Clinical Issues committee
• Statement is reviewed by legal advisor
• Review by ECEC & EC
• Circulate through membership for comments
• Review again by EC for approval
• SOARD for publication
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Gastric Plication: Is it Ready for Prime Time?
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ASMBS Policy Statement on Gastric Plication
• 4 studies (<300 patients)
• Band & plication (1 study, 26 patients)
• Recommendations:- Gastric plication should be considered investigational performed under IRB review- Encourage data reporting- Marketing should include a statement that this is investigational- ASMBS does not support CME courses on investigational procedures & devices
10/6/2011
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Gastric Plication is not Ready for Prime Time!
• Lack of scientific rationale
• Lack of data
• No evidence for metabolic effect
• Not recognized by ASMBS
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Ninh T. Nguyen, MDProfessor of Surgery
Division of GI Surgery
University of California, Irvine Medical Center
Gastric Plication: Is it Ready for Prime Time? Con