Obesity epidemic; so where does endoscopy fit in with current bariatric surgery in preoperative assessment and management of complications, and what's under development for primary endoscopic bariatric techniques-- get the skinny here!

1. Patricia L Raymond MD FACG
Rx For Sanity, Norfolk VA

2. Obesity is widespread.

3. Where does endoscopy fit in?
 pre op assessment
 endoscopic management
of complications
 primary endoscopic
bariatric in the future
Not addressing:
 selection criteria for
bariatric surgery
 efficacy of bariatric surgery
 non endoscopic
complications of bariatric
surgery

4. Pre op bariatric surgery-
controversial
 prevalence of upper gastrointestinal (GI) symptoms in patients with
morbid obesity is higher than that of the general population
 H pylori prevalence higher?
 cannot get to excluded stomach post op for ulcers, MALT, or cancer
 American Society of Gastroenterology (ASGE) 2008 guidelines
recommend screening EGD in bariatric patients who have symptoms of
GERD or dyspepsia
 Others recommend for all, even those without symptoms
 Retrospective study
 448 bariatric patients undergoing screening EGD
 141 (31%) had abnormal findings
 18% resulted in change of medical management and 0.4% change
surgical plans

5. Which endoscopies?
 EGD with biopsy for H pylori
 urease breath or stool antigen tests, accuracy of 96 and
91%
 serology assays sensitivity and specificity of greater than
95 percent in patients without atrophic gastritis or
intestinal metaplasia
 some payers require routine H. pylori screening before
bariatric surgery
 Colonoscopy for all over 60 (Cornell University)

6. Barrett’s esophagitis
 Barrett’s esophagitis (BE) incidence in morbid obesity as high as
5.8%
 regression of Barrett’s esophagus following gastric bypass has
been described (better than Nissan in obese patient with BE)
 557 RYGBs
 BE was identified in 12 (2.1%) of the subjects on routine
preoperative endoscopy
 Postop endoscopy showed regression of metaplasia in 42%
 Need to continue BE surveillance post op
NOTE: RYGB stomach remains for use for esophagectomy, VSG
leaves no remnant stomach
 VSG may be contraindicated in patients with
Barrett’s

7. Bariatric Surgeries as of 2011
 Roux-en-Y gastric bypass
 Vertical banded gastroplasty
 Laparoscopic adjustable gastric banding
 Sleeve gastrectomy
 Sleeve gastrectomy with duodenal switch

8. Roux-en-Y gastric bypass
 small stomach pouch only
able to hold an ounce of
food; over time, the pouch
stretches to hold one cup
 body absorbs fewer calories
since food bypasses the
duodenum
 intestinal arrangement
(Roux-en-Y) seems to
change the release of GI
hormones (improved
metabolism, decreased Image from: Huang CS. Endoscopy in patients who have undergone bariatric surgery. In:
UpToDate, Saltzman JR, Jones D (Ed), UpToDate, Waltham, MA, 2011. Used with permission.
appetite)

9. Roux-en-Y gastric bypass
Image from: Huang CS. Endoscopy in patients who have undergone bariatric surgery. In:
UpToDate, Saltzman JR, Jones D (Ed), UpToDate, Waltham, MA, 2011. Used with permission.

10. Vertical banded gastroplasty
 purely restrictive
procedure
 upper part of the stomach
is partitioned by a vertical
staple line with a tight
outlet wrapped by a
prosthetic mesh or band
 small upper stomach
pouch gets filled quickly by
solid food and prevents
consumption of a large
meal
Image from: Huang CS. Endoscopy in patients who have undergone bariatric surgery. In:
UpToDate, Saltzman JR, Jones D (Ed), UpToDate, Waltham, MA, 2011. Used with permission.

11. Vertical banded gastroplasty
From Huang CS, Farraye FA, Endoscopy in the Bariatric
Surgical Patient. Gastroenterol Clin N Am 34 (2005)
151–166

12. “Lap band”
 purely restrictive
procedure
 tight, adjustable
prosthetic band around
the entrance to the
stomach
 soft, locking silicone ring
connected to an infusion
port placed in the
subcutaneous tissue.
Image from: Huang CS. Endoscopy in patients who have undergone bariatric surgery. In:
UpToDate, Saltzman JR, Jones D (Ed), UpToDate, Waltham, MA, 2011. Used with permission.

13. “Lap band”
Image from: Huang CS. Endoscopy in patients who have undergone bariatric surgery. In:
UpToDate, Saltzman JR, Jones D (Ed), UpToDate, Waltham, MA, 2011. Used with permission.

14. Sleeve gastrectomy
Majority of the greater curvature
of the stomach is removed
 small capacity tubular
stomach
 resistant to stretching due to
the absence of the fundus
 few ghrelin producing cells
(a gut hormone involved in
regulating food intake).
Image from: Huang CS. Endoscopy in patients who have undergone bariatric surgery. In:
UpToDate, Saltzman JR, Jones D (Ed), UpToDate, Waltham, MA, 2011. Used with permission.

15. Duodenal switch
 partial sleeve
gastrectomy with
preservation of the
pylorus
 Roux limb with a short
common channel
 significant risks of long-
term malabsorption and
is used only for patients
with very severe obesity
(BMI >50 kg/m2).
Image from: Huang CS. Endoscopy in patients who have undergone bariatric surgery. In:
UpToDate, Saltzman JR, Jones D (Ed), UpToDate, Waltham, MA, 2011. Used with permission.

17. It would be far easier to lose weight
permanently if replacement parts
weren't so handy in the refrigerator.
Hugh Allen

18. Pulmonary embolism
 most common cause of
mortality in the
perioperative period
after weight-loss surgery
and can
 over 50 % of deaths

19. Post op bleeding 0.6 to 4.0 %
 higher rate laparoscopic versus open GBP
 surgical anastomotic and/or staple lines, and may be
intra- or extraluminal, most commonly intraluminal.
 usually resolves without surgery, but may require
transfusion and reversal of anticoagulation
 careful endoscopic examination and therapy for
continued bleeding with high transfusion needs
 surgery for hemodynamic instability, intraluminal
bleeding not amenable to endoscopic therapy (eg,
staple line of the excluded stomach) or continued
bleeding despite of normal coagulation

20. Endoscopy & late complications
 stomal stenosis
 marginal ulcers
 appliance erosion
 staple line disruption
 suture material

21. Stomal stenosis
 6 to 20 % with RYGB , higher with LRYGB
 20 to 33 percent with VBG
 several weeks post op with nausea, vomiting, dysphagia,
gastroesophageal reflux, and eventually an inability to tolerate
oral intake
 diagnosis by endoscopy or upper gastrointestinal series.
 endoscopic balloon dilation is usually successful, repeat dilation
sessions may be required
 complication rate for dilation 3 %
 surgical revision (< 0.05 %) for persistent stenosis despite
repeated dilations
 dilation for VBG may be unsuccessful (32%) due to the rigid
nature of the prosthetic band

22. Stomal stenosis
 Dilate to 10-12 mm, no
greater than 15 mm
 weight regain
 Perforation
 Recurrent stenosis
options
 glucocorticoid injection
 stent
 needle-knife
electrocautery N Am 34 (2005)
From Huang CS, Farraye FA, Endoscopy in the Bariatric
Surgical Patient. Gastroenterol Clin
151–166

23. Marginal ulcer
 0.6 to 16%
 Causes of marginal ulcers include:
 foreign material, such as staples or nonabsorbable suture
 NSAIDs
 Helicobacter pylori infection
 Smoking
 present with nausea, pain, bleeding and/or perforation
 diagnosis of a marginal ulcer by upper endoscopy
 treatment gastric acid suppression +/-
sucralfate, treatment of H pylori if present

24. Marginal ulcer
From Huang CS, Farraye FA, Endoscopy in the Bariatric
Surgical Patient. Gastroenterol Clin N Am 34 (2005)
151–166

25. H. Pylori & marginal ulcers
preoperative testing
and treatment of H.
pylori significantly
reduced the
incidence of
postoperative
marginal ulcers
(2.4% versus 6.8% in
unscreened
patients) http://www.bio.davidson.edu/people/sosarafova/Assets/Bio307/vinardone/page01.html

26. Band or mesh erosion
 band erosion 7 % of LAGB patients, occurs at a mean
of 22 months after surgery
 1 to 7 % of VBG, occurs one to three years after the
surgery
 symptoms nausea and vomiting, epigastric pain.
 hematemesis from erosion of the lap band into the left
gastric artery
 diagnosis endoscopic, treatment is surgical
 Reports of endoscopic removal of eroded lap bands

27. What does band erosion look like?

28. Staple line disruption
 results in a fistula to the fundus in VBG
 occur in 27 to 31 of VBG, may be as high as 48% if
assessed on routine postoperative endoscopy
 weight regain due to increased food
consumption, since patients can eat around their
restriction without feeling full
 surgical treatment is conversion to a RYGB or a
BPD/Duodenal switch

29. Staple line disruption
From Huang CS, Farraye FA, Endoscopy in the Bariatric
Surgical Patient. Gastroenterol Clin N Am 34 (2005)
151–166

30. OMG Staple line disruption
From Huang CS, Farraye FA, Endoscopy in the Bariatric
Surgical Patient. Gastroenterol Clin N Am 34 (2005)
151–166

31. Trial endoscopic methods for
fistulae or staple line disruption
 Expandable stent
 Full thickness staple
 Fibrin glue
 None are successful
enough for general
application at this time

32. Symptomatic suture material
 pain, marginal ulcers, and
obstructive symptoms
(secondary to food
entrapment/bezoar
formation)
 removal of foreign body
only required if
symptomatic
 cut the suture material
with endoscopic scissors
and extract with biopsy or
rat-toothed forceps
 symptom resolution or
improvement in over 80%

33. Look what we’re NOT looking at:
Weeks 1 to 6 (Phase 1) Various/Continous
- Bleeding Eating disorders
- Anastomotic leaks Nutritional deficiencies
- Obstruction Micronutrient deficiencies
Weeks 7 to 12 (Phase 2) Psychosocial
- Prolonged vomiting - Depression and sadness
- Dumping syndrome - Effects of body changes
Months 4 to 12 (Phase 3) Cosmetic issues
- Cholelithiasis
- Small bowel obstruction
- Band erosion
- Band slippage

34. Complications specific to
procedures
Roux-en-Y gastric bypass Lap band
- Gastric remnant distension - Stomal obstruction
- Ventral incisional hernia - Port infection
- Internal hernias - Band slippage and gastric
- Short bowel syndrome prolapse
- Dumping syndrome - Port malfunction
Jejunoileal bypass - Esophageal dilatation
- Electrolyte imbalances
- Renal failure
- Cirrhosis

35. Today's beauty ideal, strictly enforced
by the media, is a person with the
same level of body fat as a paper clip.
Dave Barry

36. Primary endoscopic bariatric
 duodenal electrical
stimulation
 duodenal–jejunal bypass
sleeve
 transoral guided staplers
(TOGA)
 intragastric balloon
treatment (BIB)
 gastric wall botulinum
toxin

37. Duodenal electrical stimulation (DES)
 12 healthy non-obese volunteers
 feeding tube placed in the duodenum under endoscopy.
 three ring electrodes at the end tip of the tube and the two
distal electrodes were used for recording and electrical
stimulation.
 On two separate days, water intake test and GES with actual
DES or sham randomly assigned No dyspeptic symptoms
 DES may have a potential application for the treatment
of obesity.

38. Duodenal electrical stimulation (DES)
 Delayed gastric emptying
 Reduced maximum water
ingestion by subjects
 drink water at a 37°C
temperature over a 5-min
period until reaching the
point of complete fullness

39. Various DES devices (under development)
System and method for
providing electrical pulses
to the vagus nerve(s) to
provide therapy for obesity,
eating disorders,
neurological and
neuropsychiatric disorders
with a stimulator,
comprising bi-directional
Sensor based gastrointestinal electrical stimulation for the communication and
treatment of obesity or motility disorders network capabilities United
United States Patent Application 2005022263, 2005 States Patent Application
20050049655 2005
Gastrointestinal stimulation device
United States Patent 7054690, 2006

40. Duodenal–jejunal bypass sleeve
 duodenal–jejunal bypass
sleeve
 Endobarrier ™ (GI
Dynamics™, Watertown,
MA)
 commercially available in
Chile, Germany, the United
Kingdom, Netherlands; soon
available in Australia.
 not approved for sale in the
US and is considered
investigational.
 Trial underway at Carolinas
Medical Center, Charlotte
NC

41. Duodenal–jejunal bypass sleeve
 41 study patients
 30 underwent sleeve implantation, 11 diet control group.
 All on same low-calorie diet during the study
 26 devices were successfully implanted
 Unable to implant in 4 .
 4 removed before end of study
 migration (1), dislocation of the anchor(1), sleeve obstruction (1), and continuous epigastric
pain (1).
 Mean procedure time was 35 minutes (range: 12–102
minutes) for a successful implantation
 17 minutes (range:5–99 minutes) for explantation.

42. Duodenal–jejunal bypass sleeve
 Adverse events universal
 26 sleeve patients (100%) had at least one adverse event
 mainly abdominal pain and nausea during the first week
 BMI was 48.9 and 47.4 kg/m2 for the device
and control patients at onset
 Mean excess weight loss after 3 months
 19.0% for device patients versus 6.9% for control patients (P <
0.002).
 Absolute change in BMI at 3 months was 5.5 and 1.9
kg/m2, respectively.
 Type 2 diabetes mellitus was present at baseline in 8 patients of the
device group and
 improved in 7 patients during the study period
 lower glucose levels, HbA1c, and medication requirements

43. Duodenal–jejunal bypass sleeve
Pooled study results following
12 months with EndoBarrier:
 mean absolute weight loss of
20%, or 49.5 pounds
 mean excess weight loss
(EWL) of 46.3%
 cholesterol levels dropped
from 196.5 mg/dL at baseline
to 161.0 mg/dL
 diastolic blood pressure
dropped from 84.8 mmHg at
baseline to 71.2 mmHg)
 improved type 2 diabetes
(reduction in HbA1c levels).

44. I want one!?!
$5000 anticipated cost
Not for use > 1 year

45. Transoral endoscopically guided staplers (TOGA)

46. Transoral endoscopically guided staplers
(TOGA)—revision of procedure?
 Retraction wire and sail
to keep stomach in
proper position as
suction is applied and
before stapling
 Restrictor to
pleat/narrow the lower
end of the sleeve

47. Transoral endoscopically guided staplers (TOGA)
Mean Average Absolute  11 patients
excess BMI weight
weight loss  mean BMI 41.6
loss
 No SAE
1 month 19.2% 9.9 kg
 100% successful
3 month 33.7% 17.5 kg endoscopic
stapling
6 month 46% 33.1 24.0 kg

48. Transoral endoscopically guided
staplers (TOGA)
 Pilot Clinical Study – Belgium and Italy
 As of July 2010 > 180 patients, continuing to recruit,
follow up one year
 Not commercially available
 No cost analysis available

49. Intragastric balloon treatment
 BioEnterics Intragastric
Balloon (BIB)
 Inamed Health; Santa
Barbara, CA, USA
 limited to maximum 6
months
 Follow up immediately if
urine turns blue
 Methylene blue plus 500-
700 cc saline
 nausea, vomiting and
belching within the first 3-
5 days after the BIB
introduction, usually
disappear within few days

50. Intragastric balloon treatment
 32 patients,
 mean BMI 43.7+/-1.5 kg/m2, mean %EW: 43.1 +/- 13.1
 BIB followed by sham procedure after 3 months (Group A)
 Sham procedure followed by BIB after 3 months (Group B).
 BIB filled with saline (500 ml) and methylene blue (10 ml)
 Discharged with omeprazole therapy and diet (1000 kcal)
 No AE from endoscopy, balloon placement and removal.
 Mean time of BIB positioning was 15 +/- 2 min, range 10-20
min.

51. Intragastric balloon treatment
 After the first 3 months
 Group A patients the mean BMI lowered from 43.5 to
38.0 kg/m2, Group B weight loss not significant.
 The mean %EWL was significantly higher in Group A
than in Group B (34.0 vs 2.1; P < 0.001).
 After crossover, at the end of the following 3 months, the
BMI lowered from 38.0 to 37.1 kg/m2 and from 43.1 2 to
38.8 kg/m2 in Groups A and B, respectively.

52. Want a blue balloon?
 Available in Germany,
Poland, Czech Republic,
Estonia, Slovakia, UK
 Prices range from $1800 -
$6500
 Concerns
 Trials short term and
stomach adapts
 American grazing
behavior verses European
large meals

53. Botulinum toxin
 injecting botulinum
toxin-A in the stomach
wall can be used to
manipulate appetite and
reduce food intake
 This slows down the
process of stomach
contraction so that food
takes longer empty
stomach and patients feel
full 50% sooner.

54. Botulinum toxin
 30 obese patients
 Botulinum Toxin A (120 U into the antrum and 80 U into the fundus or
saline by intraparietal endoscopic injection
 Body weight and body mass index, solid gastric emptying and
maximal gastric capacity for solids (kcal) were determined before
injection and 2 months later.
 Both treatments induced a significant reduction of body weight and
body mass index but Botulinum Toxin A exerted a significantly greater
effect
 body weight -11.8 vs. -5.5kg, p<0.0002; body mass index -4.1vs. -
2.2, p<0.001.
 maximal gastric capacity for solids was also reduced by both Botulinum
Toxin A and placebo, the former being significantly more effective
(679kcal vs. 237kcal, p<0.008)
 Botulinum Toxin A also significantly increased T(1/2) from 83.4to
101.6min, p<0.03). Placebo had no effect on gastric emptying.

55. Give me the needle!
 $10-15 per unit for botox
 200 units used = $2000 to
$3000 + cost of endoscopy
 Should we offer saline
injections routinely to
obese patients undergoing
EGD for proper
indications?
 Sclero needles $35
 Sterile saline $6
Just a thought!

56. Endoscopy fits into the skinny scene.
 pre op assessment
 Evaluate and treat H Pylori
 Assess for Barrett’s (selection of
surgery)
 Consider bariatric surgery rather
than Nissan for Barrett’s in obese
 endoscopic management of
complications
 Dilate modestly and gently
 Check marginal ulcers for H pylori
 primary endoscopic bariatric in the
future
 Slip and slide
 TOGA party
 Blue balloons
 Wrinkle free

57. Why do Fat chance and
Slim chance mean the same
thing?

58. questions?