Laparoscopic Gastric Plication for the Treatment of Severe
Obesity
Stacy A. Brethauer, MD Bariatric and Metabolic Institute Cleveland
Clinic, Cleveland, OH Minimally Invasive Surgery Symposium February
25, 2011 Disclosures Ethicon Endo-Surgery Covidien Bard/Davol
Consultant
Scientific Advisory Board Speaker Covidien Bard/Davol Research
Support Objectives Preclinical studies Variations in
Technique
Clinical Outcomes Possibilities for the future Concept of Gastric
Plication
Achieve gastric restriction No Staple Line Cost Safety No
Prosthesis Serosa-to-serosa apposition Reversible/Revisable Given
the low penetrance of bariatric surgery into the obese population
worldwide, I think it is important to pursue new interventions that
may offer a safer alternative to our current procedures or have a
specific appeal to patients or referring physicians.The concept of
gastric plication is relatively new and there is limited data
available currently, but I think it does hold promise as a
bariatric procedure.The potential advantages of this type of
procedure is that it achieves gastric restriction immediately
without a prosthetic device and without gastric resection.This has
the advantage of a lower cost procedure that has a good safety
profile and could be reversible. The major difference between this
technique and some of the emerging endoluminal therapies is that
were apposing serosa to serosa rather than mucosa to mucosa and are
therefore creating a more durable plication.There are currently no
endoluminal devices capable of achieving this degree of gastric
infolding, but the data Ill present here provides some proof of
concept that may ultimatey have an endoluminal application. 4
Preclinical Studies Evaluation of Gastric Greater Curvature
Invagination for Weight Loss in RatsFusco et al. Obesity Surgery :
Some initial animal work with this concept was published in 2006 by
a group in Brazil and they divided 30 young Wistar rats into three
groups of a sham anesthesia, a sham laparotomy, and a greater
curvature gastric plication. The weight curves are shown here and
the there was a significant decrease in weight gain in the greater
curve rats at 21 days. 6 Comparison of Anterior Gastric Wall and
Greater Gastric Curvature Invaginations for Weight Loss in Rats
Fusco et al. Obesity Surgery : They followed that study up with
another rat study in which they compared 10 rats that underwent a
greater curve plication to 10 rats that underwent an anterior
plication without division of the greater curve vessels 7 Weight
difference significant only at 21 days
Comparison of Anterior Gastric Wall and Greater Gastric Curvature
Invaginations for Weight Loss in Rats Fusco et al. Obesity Surgery
: Weight difference significant only at 21 days No difference in
gastric volume measurement or epididymal fat pad wt at 28 days They
did not find a significant difference at 28 days between the two
groups in their weight gain or epididymal fat pat size 8 Gastric
plication: a preclinical study
of the durability of serosa-to-serosa apposition Menchaca et al.
Surg Obes Relat Dis. 2011;7:8-14 Schematic of T-Tags (left) and
buttressed T-Tags (right) Serosa to Serosa Apposition
3 Weeks Post Op: Serosa to Serosa apposition has healed together
through the creation of an adhesion 8 Weeks Post Op: Serosa to
Serosa appostion zone has been replaced with fibrous connective
tissue Figure 5 Photomicrograph of distal pyloric region. The
layers of the stomach wall (M = internal muscle tunic; m = external
muscle tunic; muscle stains pink) are folded.The apposed serosal
layers have healed together to form a 1-2 mm fibrous connective
tissue bridge (S; collagen stains blue.)Spaces with sutures are
shown (arrows.)Some sections of GVR sites with serosal abrasion
were similar in appearance.Massons trichrome stain.
confidential/for EES internal use Preclinical Durability
Studies
Questions: Can serosa-to-serosa healing be achieve in a controlled
manner? Is serosal treatment required? What type of fastener is
needed? What type of pattern is needed? Is this procedure
reversible or convertible? Acceleration plan increases cumm revenue
from LGCP in year 2016 to 41.40MM from and revenue in 2016 from to
23.78 confidential/for EES internal use Fastener Spacing and Number
of Rows
Braided Suture 3 Rows ~1cm spacing Braided Suture 1 Row ~2cm
spacing Titanium Staple 3 Rows Interior Rows: ~2cm spacing Outer
Row: ~1cm spacing confidential/for EES internal use Titanium Clip
vs. Suture
Device Equivalence Methods: 10 dogs (5 Staple, 5 Suture), 8 weeks
survival Mean procedure times for sutured and clip techniques were
53.5 and 25 minutes, respectively (p=0.028). Results: 100% of folds
intact under endoscopic visualization; No significant difference
observed between groups (p=0.317) Reversibility: All stapled
animals were reversed and recovered normally; one sutured animal
was reversed, but was not survived Results from the pre-clinical
comparative study between suture and stapling. confidential/for EES
internal use Reversibility 2 weeks Post-reversal Clinical
Studies-Technique Variations in Technique Laparoscopic Greater
Curvature Plication
Suture Type Suture Pattern Suture Spacing Depth of Fold Calibration
Use of Endoscopy Our Initial Technique for Greater Curvature
Plication
This video is not intended to be used as a surgical training guide.
Other surgeons may employ different techniques. The steps
demonstrated may not be the complete steps of the procedure. Before
using any medical device, including those demonstrated in this
video, review all relevant package inserts, with particular
attention to the indications, contraindications, warnings and
precautions, and steps for use of the device. 21 Endostitch Initial
Suture Row Intraoperative Endoscopy Final Plication Fastener
Technique Clinical Studies - Outcomes Mean weight loss 26.4 +/- 8.7
kg (13-51 kg)
Age y BMI kg/m2Mean=37.47Kg/m2 Results at 1 year: Meanweight loss
/- 8.7 kg (13-51 kg) Mean %EWL / (6.2 95.6) No reported
complication or mortality 70% of patients below 40 BMI Laparoscopic
Greater Curve Plication Ramos et al
Laparoscopic Greater Curve Plication Ramos et al. Obes Surg 2010
Jul;20(7):913-8 42 patients Mean BMI 41 kg/m2 Mean operative time
50 minutes Mean length of stay 36 hours No major complications Mean
62% EWL at 18 months OUTCOME OF LAPAROSCOPIC TOTAL VERTICAL GASTRIC
PLICATION IN MORBID OBESITYTalebpour M, Amoli B. J Laparo Adv Surg
Tech 2007; 17: N=150, Mean BMI 47 61% 60% 57% 57% 72p 51p 55% 94p
23p 10p OUTCOME OF LAPAROSCOPIC TOTAL VERTICAL GASTRIC PLICATION IN
MORBID OBESITYTalebpour et al.
Complications 1 liver hematoma Reoperation % 4 patients 1 leak from
suture line 1 prepyloric perforation 1 liver abscess 1persistentn/v
due to adhesions kinking the stomach No Mortality Laparoscopic
Gastric Plication for the Treatment of Severe Obesity Brethauer et
al. Surg Obes Relat Dis.2011;7:15-22 IRB approval obtained 15
patients (three male) Mean preop BMI 43.5 (36.9 49.0) 9 patients
underwent anterior surface plication 6 patients underwent greater
curvature plication METHODS Progression of diet from liquid to
solid over 4 week period postoperatively Endoscopy at 3,6,and 12
months postop Weight loss Adverse events Anterior Plication Greater
Curvature Plication Results Volume reduction with intraluminal fold
achieved in all patients based on endoscopic assessment in OR Mean
procedure time AP 89 minutes GCP 72 minutes Mean LOS 37 hours First
2 Greater Curvature patients with severe nausea with LOS 77 hours
Results Endoscopy at 3 and 6 months
Anterior Plications (n=6):Onepartially disrupted fold Greater Curve
Plications (n=6): One plication disrupted distally with broken
intraluminal suture Endoscopy 12 months Anterior Plications (n=5):
Same as 6 mos Greater Curve Plications (n=6) Same as 6 mos Anterior
Plication 6 months 12 months Greater Curvature Plication
12 months 6 months Weight Loss Procedure Three Months Twelve Months
N BMI %EWL 9
Anterior 9 -4.8 +/- 1.4 23.0 +/- 6.4 7* /- 4.5 19.8 +/ ** Greater
Curvature 6 -7.8 +/- 1.5 38.9 +/- 8.2 /- 5.5 53.9 +/- 22.3 *
patients lost to follow-up **Data from 2 patients collected after
scheduled 12 month visit Complications No bleeding or infectious
complications
First GCP patient required reoperation and plication reduction on
POD#2 due to gastric obstruction Mild to moderate nausea in all
patients (2 severe). Resolved within two weeks. 1 Lap
cholecystectomy 11 months after procedure Comparison to Other
Studies Multicenter Trial Underway
3 centers 45 patients 3 year follow-up All sutured Greater Curve
Plication Standardized technique Enrollment complete Preliminary
Results Encouraging At 12 months (our site) Mean BMI decreased from
43.4 to 34.4 Laparoscopic Gastric Plication Summary
Anterior Plication safe, but not effective Greater Curve Plication
Technically feasible, reproducible Good short-term weight loss Low
major complication rate Long-term safety and weight loss data
needed Remains investigational The Future? Thank You