Highlights on the role of endoscopy in Bariatric surgery Magdy F.Giurgius,MD,MB CHB,MSc General Surgery, Minimally Invasive and Bariatric surgery Diagnostic and Therapeutic Endoscopes Ozarks Medical Center West Plains, Missouri

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Gap/Need Ongoing identification of new procedures and emerging technologies that should be evaluated for introduction into surgical practice Following evidence-based evaluation, if a new modality is found ready for adoption in practice, surgeons need education about the safe and effective use of the new modality

Credentialing and privileging to perform a new procedure or use an emerging technology should be based on evaluation of knowledge, skills and outcomes of surgical care, and not merely on the numbers of procedures performed Safe Introduction of New Procedures and Emerging Technologies in Surgery: Education, Credentialing, and Privileging ,Volume 87 ,issue 4 August 2007, Pages 853–866

Objectives 1-Identify the role of diagnostic endoscopes in Bariatric surgery 2-Outline the therapeutic aspects of endoscopes in Bariatric surgery 3-Illustrate the importance of maintaining endoscopic surgical skills for general surgeons

Expected Outcome Better understanding about the role of diagnostic and therapeutic endoscopes in bariatric surgery. Continue to have competent surgeons mastering endoscopic skills

Overview Preoperative role Intra-operative Post-operative New lines

Overview There are more than half a million Bariatric surgeries performed annually worldwide Complications can occur Surgical interventions are often difficult and can result in more complications

Common Bariatric procedures Laparoscopic RYGB Laparoscopic Gastric sleeve Laparoscopic Adjustable gastric band

Benefits of Endoscopes No incisions Faster recovery Less risk of DVT/PE Less pain if any Outpatient procedure

Endoscopic Complications Aspiration Perforation Bleeding Mallory-Weiss tear less than 0.1% Reaction to sedatives /Anesthesia Respiratory Insufficiency Mortality -0.01%

Preoperative assessment Evaluates the diagnostic yield of (EGD) before bariatric surgery and its influence on the planned surgery

Endoscopy plays an important preoperative role in bariatric surgery The role of upper endoscopy (EGD) in obese patients prior to bariatric surgery is controversial Routine upper endoscopy before bariatric surgery has a high diagnostic yield and has a low cost per clinically important lesion detected. Obes,Surg,2004 Nov-Dec;14(10):1367-72.

The role of endoscopy in the bariatric surgery patient Preoperative endoscopy with EGD can identify patients with asymptomatic anatomic findings that may alter surgical planning.

Patients with symptoms of GERD, such as heartburn, regurgitation, dysphagia, or any postprandial symptoms that suggest a foregut pathology and/or who chronically use antisecretory medications, should have an upper GI endoscopic evaluation before bariatric surgery

Endoscopic findings resulted in an alteration of the surgical approach or delay in surgery ranging from less than 1% to 9% of patients Testing and eradication of H pylori before bariatric surgery should be individualized. GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5 : 2015

Another study Efficiency of preoperative EGD in identifying operable Hiatal hernia for bariatric surgery patients Small HH are over-diagnosed with EGD, as most do not require repair. However, moderate and large HH are accurately detected. Surg Obes Related Dis.2016 Aug 17. pii: S1550-7289(16)30187-3. doi: 10.1016/j.soard.2016.08.015

Intraoperative Role of routine intra-operative endoscopy in laparoscopic bariatric surgery Routine intra-operative endoscopy identified 34 correctable technical errors in a series of 825 laparoscopic bariatric procedures. Of these, 33 (97%) were repaired successfully, which reduced postoperative morbidity Surg Endosc, December 2002, Volume 16, Issue 12, pp 1663–1665

Intraoperative endoscopic test of pouch and Gastrojejunal anastomosis in 366 Laparoscopic Roux-en-Y Gastric Bypasses Staple line submerged under saline with endoscopic insufflation and placement of a bowel clamp on the intestinal limb distal to the GJA

  Many "leak prophylaxis" measures have been emerging to prevent this potentially devastating complication. However, checking the GP and GJA with a simple endoscopic test can minimize the incidence of leaks after LRYGBP. Obesity Surg, September 2004, Volume 14, Issue 8, pp 1067–1069

Postoperative Assess for causes of abdominal pain(GJ ulcer) Disimpaction of food or Pills Assess anatomy Diagnose and treat bleeding Dilate strictures Narrow dilated stomas Stent leaks Explanation of gastric Bands Assess and manage fistulae

POSTOPERATIVE ENDOSCOPIC EVALUATION OF THE BARIATRIC SURGERY PATIENT Review pertinent operative notes and previous imaging studies (both preoperative and postoperative) and must understand the expected anatomy, including the presence of altered gastric anatomy and the extent of resection and length of surgically created intestinal limb Volume 81, No. 5 : 2015 GASTROINTESTINAL ENDOSCOPY 1065

Laparoscopic assisted Endoscope(ERCP) Performing endoscopic retrograde cholangiopancreatography (ERCP) in patients with prior Roux-en-Y gastric bypass (RYGB) surgery is challenging Despite advancements in endoscopic technology, reaching the duodenum and entering the bile duct is still difficult

Laparoscopic assisted ERCP (LAERCP) allows the duodenum to be accessed through the excluded stomach

 Consecutive patients undergoing LAERCP between 2005 and 2010 were used for this study. Biliary/pancreatic cannulation, endoscopic/laparoscopic interventions, post procedure complications, hospital stay, and procedure time were observed in this study.

Fifteen patients with post-RYGB surgery underwent LAERCP. Endoscopic ante-grade access to the papilla was achieved through the gastric remnant in all. Canulation and interventions in the pancreatic biliary tree were successful in all cases

There were no postoperative complications related to the endoscopic portion of the procedure. The mean duration of the procedure and the median post-procedure hospital stay were 45 min and 2 days, respectively. Laparoscopic assisted ERC is a useful approach in the diagnosis and treatment of pancreatico-biliary conditions in patients with RYGB J Gastrointestinal Surg2012 Jan;16(1):203-8. doi:10.1007/s11605-011-1760-y. Epub 2011 Nov 1

Strictures Stenosis in gastric bypass: Endoscopic management Stenosis of the gastrojejunal anastomosis is a recognized complication Diagnosis is usually obtained by endoscopy

Etiology  The pathophysiology involved in the formation of stenosis are not well known, although situations such as stomal ulcer, reflux, ischemia of the suture line, retraction of the scar, or an inadequate technique, may contribute to its appearance

 Stenosis of the GJ occurs in approximately 3%-27% after gastric bypass, and must be suspected when the patient experiences dysphagia (initially with solids and subsequently with liquids), nausea and vomiting

Membranous strictures occur after a period of prolonged fasting. These are easily treated by endoscopic balloon dilatation; Cicatricial strictures are a direct consequence of erosion by a foreign body, ulceration, or anastomotic leaks. These are characterized by intense fibrosis and respond unpredictably to endoscopic balloon dilation. Surgical revision is not uncommon.

Post-gastric bypass gastrojejunostomy strictures can be graded endoscopically and classified into four groups: Grade I: Mild stenosis, which will allow about a 10.00-mm endoscope to pass; Grade II: Moderate stenosis, which will accommodate an 8.5 mm pediatric endoscope; Grade III: Severe stenosis, through which a guide-wire can be passed; Grade IV: Complete/near-complete obstruction, which is non-traversable.

Intraoperative endoscopy or the infusion of methylene blue into the gastric pouch via a nasogastric tube to assess the integrity of the gastrojejunal anastomosis, reduces the likelihood of postoperative leaks, which complicate approximately 1.4% to 2% of RYGBP

Treatment TTS balloon dilators provide radial dilation and gradual expansion, thus preventing excessive pain and minimizing the likelihood of perforation The balloons may be inflated with water, saline solution, or water-soluble contrast medium. The inflation device, which attaches to the balloon catheter hub, contains a pressure gauge in order to ensure proper balloon inflation.

The deflated balloon should be positioned so that the anastomotic stricture is aligned with the balloon’s midpoint. The position of the balloon is maintained for 1 min after complete inflation to ensure adequate dilatation of the stricture Once the dilatation is complete, the patient is discharged home and dietary instructions are given

The efficacy of Bougie dilatations in the treatment of stomal strictures after bariatric surgery is very limited Dilation with Bougies is a popular method for treating esophageal strictures

Advantages of balloon dilatation include the fact that fluoroscopy is often not required and the stricture is dilated under direct endoscopic visualization Additionally, balloon dilation allows the ability to dilate the stoma while performing the diagnostic endoscopy World J Gastrointestinal Endosc. 2012 Jul 16; 4(7): 290–295

Ananstomotic stricture 5-10% Endoscopic Pneumatic balloon dilation Single dilatation---------67% Twice-----------------------30% Thrice-----------------------3% Surg Endosc March 2003, Volume 17, Issue 3, p 416–420Barba CA et al

Laparoscopic Gastric Sleeve Stricture may occur on the long staple line,particulary the Incisura. Ischemia Over sewing • Other Technical Issue(under tension) Leak or bleeding may predispose to stricture. Surgical Endoscopy. 17(3):416-20, 2003 Mar.

Can J Surg. 2013 Oct; 56(5): 347–352.doi: Radiograph showing a normal image of the stomach after laparoscopic sleeve gastrectomy. Can J Surg. 2013 Oct; 56(5): 347–352.doi:  Complications associated with laparoscopic sleeve gastrectomy for morbid obesity: a surgeon’s guide

Gastric Sleeve strictures The reported post Gastric sleeve strictures, between 0.7-4% in different studies Gastrointestinal endoscopy March 2014 Volume 79, Issue 3, Pages 521–524Balloon dilatation for symptomatic gastric sleeve stricture

Most strictures can be effectively managed with balloon dilation. May require a second session, but over 90% are managed with 1 or 2 dilations. Perforation is reported in 2% of patients in some larger series (2/94). N Rosenthal. Surgery for Obesity & Related Diseases. 2(2):92-7, 2006 Mar-Apr. Journal of Gastrointestinal Surgery. 7(8):997-1003, 2003 Dec. American Journal of Surgery. 189(3):357-60, 2005 Mar Gastrointestinal Endoscopy. 66(2):248-52, 2007 Aug.

Balloon dilators of 12-18 mm have been described. Procedure may be done with fluoroscopic assistance Inflate the balloon and hold for 1 minute • Repeat if necessary Nguyen. Journal of Gastrointestinal Surgery. 7(8):997-1003, 2003 Dec. Surgical Endoscopy. 17(3):416-20, 2003 Mar

GI leaks GI leak remains an important cause of overall morbidity and mortality after primary stapled bariatric procedures. The etiology of GI leaks is multiple but generally falls into mechanical/tissue causes or ischemic causes, both of which involve intraluminal pressure that exceeds the strength of the tissue and/or staple line

Technical factors that have been associated with an increased risk of a leak include; Bougie size < 40F(increase intra-luminal pressure) Narrowing or stricture of the sleeve conduit, particularly at the level of the gastric Incisura Inadvertent stapling of the esophageal wall (rather than gastric tissue) at the GE junction when creating the proximal staple line

It is estimated that 75%–85% of leaks after SG will occur at the proximal third of the greater curvature staple line as opposed to the distal or antral staple line Leaks have been reported to occur in the early postoperative period within a few days of surgery; however, most series have reported leaks occurring after > 5 days (5 to > 8) after surgery in 50%–80% of patients

Among reports, sensitivity of upper GI contrast examination varies between 22% and 75% CT of the abdomen after RYGB can detect leaks, abscesses, and bowel obstruction, and may be better able to recognize suspected leaks of the jejunojejunostomy and/or remnant stomach 

Staple line leak Gastric leak is one of the most serious and dreaded complications of LSG . It occurs in up to 5% of patients following LSG. Several classifications exist based on the radiologic findings and time of diagnosis.  Based on upper gastrointestinal contrast study, gastric leak can be classified into 2 types. A type I or subclinical leak is controlled either through a surgical drain or through a fistulous tract into the abdominal or chest cavity

A type II or clinical leak is a disseminated leak with diffusion of the contrast into the abdominal or chest cavities.  Based on the time of diagnosis, gastric leaks are classified as early or late. An early leak is generally diagnosed within the first 3 days after surgery, whereas a delayed leak is usually diagnosed more than 8 days after surgery.

Management Stable patients Non-operative methods of GI leak treatment after both GB and SG include endoscopic endoluminal self-expandable stents, clips, endoscopic and percutaneous placed drains, and biologic glue/tissue sealants The majority of patients treated with an endoluminal stent achieve complete healing with a success rate of 55%–100%)

Management of leaks in Un-stable patients Operative management Placement of drains to create controlled fistulas, use of antimicrobial agents, and nutrition considerations TPN/Enteric Distal feeding tube placement feeding J in SG or Gastric remnant G tube in RYGB.

Management of non-healing fistulas. Interest in biological glue has grown from case reports of successful treatment of gastrointestinal fistulae with fibrin glue injection laparoscopic or open gastrojejunal anastomosis conversion SG to GB Total Gastrectomy & esophago-jejunostomy

 All that should be expected is that the physician will follow a reasonable course of action based on current knowledge, available resources, and the needs of the patient, in order to deliver effective and safe medical care The American Society for Metabolic and Bariatric Surgery Clinical Issues Committee Approved by the ASMBS Executive Council, May 2015

Prevention of leaks In several studies, there were fewer leaks in the group with buttress material, compared to the non-buttressed group Obes Surg. 2004;14:1360–1366. Obes Surg. 2002;12:474–475. Obes Surg. 2003;13:37–44.

Gastric leaks post sleeve gastrectomy: Review of its prevention and management World J Gastroenterol . 2014 Oct 14; 20(38): 13904–13910. Published online 2014 Oct 14. 

Dilated Gastro-jejunosotomy Long Term Follow Up Of Endoscopic Sclerotherapy For Dilated Gastrojejunostomy After Gastric Bypass Giurgius M1, Fearing N, Weir A, Micheas L, Ramaswamy A Surg Endosc.2014 May;28(5):1454-9. doi: 10.1007/s00464-013-3376-7. Epub 2014 Jan 30.

Weight Regain Weight regain has been increasingly recognized as an issue as reported in studies with long-term follow-up Proposed causes include Dietary habits Lack of exercise Gastrogastric fistula Dilated gastric pouch Enlarged gastrojejunostomy (GJ) Nutrition 28 (2012) 53–58 OBES SURG (2012) 22:1586–1593

Dilated Gastrojejunostomy 165 patients undergoing endoscopy at mean of 4.6 years post RYGB ABU DAYYEH et al CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2011;9:228–233

Dilated Gastrojejunostomy Proposed mechanism Loss of satiety due to quicker emptying of the gastric pouch

Dilated Gastrojejunostomy Options for treatment Revisional bariatric surgery Endoscopic options Suturing Plication Sclerotherapy

Sclerotherapy Endoscopic injection of sub mucosal sodium morrhuate circumferentially at the GJ

Study Aim Assess the long term outcomes of endoscopic sclerotherapy for a dilated gastrojejunostomy (GJ) following RYGB procedure with regards to weight loss

Methods A retrospective review of 48 patients who underwent sclerotherapy for dilated GJ (2007 -2012) was performed at University of Missouri, Columbia Multivariate analysis was used to study factors associated with weight change

Methods Medical Bariatrician weight check dietary counseling Medical Bariatrician for Weight Regain Diagnostic Upper Endoscopy Initial Sclerotherapy Medical Bariatrician weight check dietary counseling Repeat sclerotherapy

Methods 1. A large rat tooth forceps was used to estimate the size of the gastrojejunostomy 2. A standard injection needle was used 3. Sodium morrhuate was injected submucosally to create a bleb with 1-2 cc at each site 4. This injection was continued circumferentially

Methods Patients were discharged with Narcotics for pain control Proton pump inhibitors x 1 month Sucralfate x 1 month Clear liquid diet for the first 12 hours

Results 48 patients identified Original gastric bypass procedures 1991 -2007 Years after RYBG that sclerotherapy was performed 5 years (range 2-15)

Results Median patient age 49.5 years (range 22-63) 92% females The median follow-up after sclerotherapy 22 months (12-60 months) 1 year or more of follow-up 56.2% 2 years or more of follow-up 39.5% 4 or more years follow-up 15%

Results Weight loss from the primary procedure 120 (range: 65-273 lbs) Weight regain prior to sclerotherapy 34 (range:0-227)

Results Pre-procedure measured gastrojejunostomy diameter 25 mm (range: 15-35 mm) Number of sclerotherapy sessions 2.0 (range: 1 – 4) Volume of sodium morrhuate injected 12.8 ml (range: 3-22)

Results Weight prior to initial RYGB Lowest weight following RYGB median=304.5 (range: 225-518) Lowest weight following RYGB median=190 (range: 99-322) Weight prior to first sclerotherapy session median=218 (range: 154-340) Latest available weight median=22o.5 (range: 155-332)

Results Weight prior to initial RYGB Lowest weight following RYGB median=304.5 (range: 225-518) Lowest weight following RYGB median=190 (range: 99-322) Weight prior to first sclerotherapy session median=218 (range: 154-340) Latest available weight median=22o.5 (range: 155-332) p<0.05

Results Weight prior to initial RYGB Lowest weight following RYGB median=304.5 (range: 225-518) Lowest weight following RYGB median=190 (range: 99-322) Weight prior to first sclerotherapy session median=218 (range: 154-340) Latest available weight median=22o.5 (range: 155-332) p<0.05

Results Weight prior to initial RYGB Lowest weight following RYGB median=304.5 (range: 225-518) Lowest weight following RYGB median=190 (range: 99-322) Weight prior to first sclerotherapy session median=218 (range: 154-340) Latest available weight median=22o.5 (range: 155-332) p: ns

Multivariate models The results remained unchanged when controlling for: Volume of Sodium Morrhuate injected Patient age Gastrojejunostomy diameter Number of sclerotherapy sessions Number of years of follow-up Stabilization or decrease in stoma diameter on subsequent sessions

Results Weight stabilization or loss following sclerotherapy 46% of patients Median weight loss from prior to initial injection to final weight 9.5 (ns)

Model: estimated average patient weight over time with multivariate analysis standard errors

Limitations Retrospective Small sample size Estimation of gastrojejunostomy size

Gastrointest Endosc 2012;76:275-82 Other studies Abu Dayyeh et al. Gastrointest Endosc 2012;76:275-82

Conclusion At long term follow-up of patients undergoing sclerotherapy of the gastrojejunostomy for weight regain following gastric bypass, there is only a marginal weight loss which was not statistically significant in our study population No predictors of weight loss were identified

Endoluminal Surgery New Lines

Endoscopic Intra-gastric Balloon Indications Adult obese(between 18 and 60 years) FDA approved for BMI 30-40 Participation with a supervised program(diet and behavior modification)

Contraindications -Inflammatory disease of the GI tract (PUD,IBD,… - Potential upper gastrointestinal bleeding, blood thinners - Congenital or acquired abnormalities of the G.I. tract such as Artesia or stenoses  - Mentally challenged, emotionally unstable that makes the subject a poor candidate  - Alcoholics or drug addicts   - Large Hiatal hernia  - Previous open abdominal surgery

Patient selection (Motivated/realistic expectations/active support network Thorough history and physical Weight loss mean EWL at six months is 38%

Side effects Nausea 87% Vomiting 76% Abdominal pain 58% GERD 30% Others;Belching,constipation,dypepesia,distention,dehdration,diarrhea,…..

Procedure Sedation(IV propopofol) can be done in the GI lab Once inserted carefully into the stomach, the silicone balloon is then filled with up to 700 cc of a safe saline solution Ambulatory procedure, patient can go home the same day Explantation after 6 months(intubation)

Endoscopic Bariatric Therapies Dual intra-gastric Balloon Adjustable Intra-gastric Balloon Gas filled Balloon

Single Intra-gastric Balloon

Dual Intra-gastric Balloon

Adjustable Intra-gastric Balloon

Gas filled Balloon

Other Endoluminal procedures Endo-luminal delivered solid silicone funnel-type Modified fully-covered gastro-esophageal stent with a cylindrical esophageal component and a gastric disk Aspiration Therapy Endoscopic Sleeve Gastroplasty Gastrointestinal Bypass Sleeves

Endo-luminal delivered solid silicone funnel-type device that delays gastric emptying by intermittent sealing of pylorus with peristalsis.

Modified fully-covered gastro-esophageal stent with a cylindrical esophageal component and a gastric disk that are connected by struts, which ensure that the gastric disk applies pressure on the gastric cardia to induce satiety.

Specially designed percutaneous gastrostomy tube, known as the A-Tube. The tube is made of silicone and is inserted in a fashion similar to that of a PEG tube.

Endoscopic Sleeve Gastroplasty

Transoral sleeve gastroplasty provides alternative to bariatric surgery Gastrointestinal Endoscopy. 2013;78:530.

Gastrointestinal Bypass Sleeves

Duodenal Mucosal Resurfacing

Self-assembling Magnets for Endoscopy GASTROINTESTINAL ENDOSCOPY Volume 81, No. 5 : 2015

Conclusion Role of diagnostic endoscopies in Bariatric surgeries. Endotheraputic aspects in Bariatric surgery. General and Bariatric surgeons should maintain Endoscopic skills/Credentials. Future for Endoluminal surgeries.