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F Chow Queen Mary Hospital, University of Hong Kong. Joint Hospital Surgical Grand Round 16 July, 2016. Gastroesophageal reflux disease: from surgeon’s perspective. Gastro-esophageal reflux disease (GERD).
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F Chow Queen Mary Hospital,University of Hong Kong Joint Hospital Surgical Grand Round 16 July, 2016 Gastroesophageal reflux disease:from surgeon’s perspective
Gastro-esophageal reflux disease (GERD) • “Reflux of stomach contents that causes troublesome symptoms and/ or mucosal injury in the esophagus” (Montreal definition 2006) • First-line therapy: Proton pump inhibitors (PPI) • Typical symptoms: • Heartburn • Regurgitation • Acid brash • Reflux esophagitis • Reflux stricture • Barrett’s esophagus • Esophageal adenocarcinoma Vakil N, et al. Montreal definition, 2006
Flow of presentation • Pathophysiology and Diagnostic evaluation • Anti-reflux surgery (laparoscopic fundoplication) • Indications • Comparison with Medical therapy (PPI) • Operative approaches • Side effects & Failed cases • LINX (magnetic augmentation device) • Endoscopic treatment • Radiofrequency ablation (Stretta system) • Trans-oral incisionless fundoplication (EsophyX)
Pathophysiology • Endogenous anti-reflux mechanism = lower esophageal sphincter + spontaneous esophageal clearance • Poor esophageal motility • Incompetent LES • Hypotensive LES • ↑intra-abdominal pressure • Inappropriate transient LES relaxations (TLESRs) • Delayed gastric emptying • Hiatal hernia Singhal V. Preoperative Evaluation of GERD, 2015
Diagnostic evaluation for GERD • Indicated for (1) refractory disease or (2) before surgical/ endoscopic intervention • Objectively confirms the diagnosis of GERD • Predicts outcome following any procedure • Upper endoscopy • to identify complications (e.g. esophagitis, stricture, Barrett’s) and hiatus hernia • High specificity (95%) but low sensitivity (50%)
Diagnostic evaluation for GERD • Ambulatory pH monitoring • Gold standard confirmation test • Trans-nasal catheter or BRAVO capsule • Total reflux time (pH <4) greater than 4.2% over 24hr • DeMeester score (normal <14.72) • Symptom correlation • Symptom index > 0.5 • Symptom-associated probability help set patients’ expectations on which symptoms are likely to resolve after procedure
Diagnostic evaluation for GERD • Multichannel intraluminal impedance (MII) • More comprehensively characterize refluxate • including non-acid bolus, gas • High-resolution manometry (HRM) • Esophageal body peristalsis and contraction amplitude • LES pressure (?hypotensive) and length (?short) • Rule out achalasia/ other esophageal motility disorders
Anti-reflux surgery (ARS) • Mechanical anti-reflux barrier • Effective against different types of reflux • Curative in 87.7% at 5yrs, 72.9% at 10yrs • Gold standard:Laparoscopic fundoplication + hiatal reconstruction+ restore adequate length of intra-abdominal esophagus • Floppy valve around EGJ • Restores the Angle of His • ↑LES basal pressure, ↓TLESR, ↓ capacity of gastric fundus thereby speeding gastric emptying Stefanidis D. SAGES guidelines, 2010
Laparoscopic Nissen fundoplication 3 1 4 2 Yates RB, 2015
Indicationsfor Surgical Therapy in GERD *Patients in need of long-term treatment of GERD
Indicationsfor Surgical Therapy in GERD *Patients in need of long-term treatment of GERD
Anti-reflux Surgery vs. Medical treatment • 4 RCTs (n=1060), low quality of evidence • No result on long-term health- or GERD-related QOL 2015 better short-term symptomatic relief still considerable uncertainty in the balance of benefits vs. harms *Serious complications in surgical group mainly are reoperation (either ‘redo’ fundoplication or reversal of fundoplication) and mortality; major adverse effects with long-term PPI include osteoporotic fracture, clostridium difficile infections pneumonia
ARS vs PPI More evidence – recent trials • In PPI responders, laparoscopic anti-reflux operation is an effective alternative. Most patients remain in remission at 5 years in both groups. Residual reflux symptoms and procedure side-effects are well tolerated. Galmiche JP, 2011
ARS vs PPI More evidence – recent trials • At 5 years, laparoscopic fundoplication continue to provide better relief of GERD symptoms than medical management. • Adverse effects were uncommon; a small proportion had re-operations. Grant AM, 2013
Anti-reflux Surgery – Operative approaches Nissen fundoplication Toupet fundoplication Anterior (Dor) Broeders JA. Meta-analysis of LNF vs LTF, 2010; Broeders JA. Meta-analysis of LAF vs LPF, 2011
Anti-reflux Surgery – Operative approaches Nissenfundoplication Toupet fundoplication • Laparoscopic Nissen fundoplication is proven very effective in controlling reflux over long periods of time • Toupet seems offer similar effective control, but with less post-operative side effects; more level 1 evidence with longer FU periods is required • Currently surgeons should perform the fundoplication they are most comfortable performing Dallemagne B, 2006; Broeders JA. Meta-analysis of LNF vs LTF, 2010 (7 RCTs)
Anti-reflux Surgery – Operative side effects DYSPHAGIA • Expected mild temporary dysphagia in post-op 2-4 weeks • If severe or persistent beyond 3 months Barium swallow • Over-tightening of hiatus during hiatal repair, Excessive peri-hiatal scar tissue formation • 6-12% post-op patients need dilatation (bougie) • Surgical revision – widening of hiatus, conversion of Nissen to parital fundoplication Dominitz JA. Complications and meds use after surgery, 2006
Anti-reflux Surgery – Operative side effects GAS BLOAT SYNDROME • Fewer transient LES relaxations i.e. belching • NOT predicted by pre-operative symptoms • Partly due to GI hypersensitivity to gaseous distension • Early post-op period: nasogastric decompression may help • Symptoms tend to lessen over time • Rarely need conversion from full to partial fundoplication Kessing BF, 2013
Anti-reflux Surgery – Failed cases REVISIONAL SURGERY • For anatomic problems with the fundoplication or hiatus • 5- and 10-year cumulative reoperation rate: 5.2%, 6.9% 1 • Recurrent reflux failed PPI, dysphagia • Laparoscopic re-operation is viable and safe • Higher complication rate than primary repair 2 • Zhou, 2015 • Moore, 2016
LINX reflux management system • Expandable bracelet of magnetic beads around OGJ • Improves the barrier function of LES • Inserted by a simple standardized laparoscopic procedure • Does NOT alter the hiatal and gastric anatomy • Contraindicated when hiatal hernia >3cm Ganz RA, 2013
LINX – magnetic sphincter augmentation • Compared with lap fundoplication (few retrospective studies with short FU), • Similar efficacy in reducing esophageal acid exposure and PPI usage • Improvement in GERD-HRQL score was similar Lipham JC. LINX : confirmed safety and efficacy at 4yrs, 2012 Ganz RA. Long-term outcomes of magnetic sphincter augmentation, 2016
LINX – magnetic sphincter augmentation Early evidence suggests efficacy and safety of the magnetic sphincter augmentation device on moderate GERD in short- and medium-term. More high-level evidence and long-term results are needed • Compared with lap fundoplication (few retrospective studies with short FU), • Short-term post-operative dysphagia similar • Bloating or flatulence actually reduced after LINX implantation • Almost all patient were able to vomit or belch when they needed Ganz RA, 2016; Zhang 2015
Endoscopic treatment – Stretta system • Radiofrequency ablation into esophageal wall & LES complex • Tissue remodeling and contraction at LES reduced compliance and tightening of sphincter • Improves symptoms, partially improves QOLNOT normalizes esophageal acid exposure/ increases LES pressure • An appropriate therapy option in patients who decline laparoscopic fundoplication [SAGES] Stefanidis D. SAGES guidelines, 2010; Perry K. Meta-analysis, 2012
Endoluminal fundoplication –EsophyX • Transoral incisionless fundoplication (TIF) – creates a 270 degree 2-3cm esophgogastric fundoplication • Mimics lap Nissen fundoplication • Recreates the dynamics of the angle of His • Restores the distal high-pressure zone Hummel K, 2015
Endoluminal fundoplication –EsophyX • Effective in short term (6months – 2yrs) • More effective than PPIs in eliminating troublesome regurgitation • Reduces GERD-HRQL • Achieves cessation of PPI therapy in 67% patients at 8 months • ↓esophageal acid exposure but fails to normalize • Complications: hemorrhage (1.1%), esophageal perforation (0.7%), dysphagia (0.5%), bloating (1.3%) • Overall failure rate requiring re-intervention is 8.1% at 9months • Appears effective in short term, awaits long-term data to define optimal techniques and patient selection criteria [SAGES] Welding MR, 2013; Trad K. RCT, 2015
Conclusion • Optimal outcome achievable with minimally invasive anti-reflux surgery is at least as good as medical therapy, possibly some-what better in the long-term. • Thorough pre-operative evaluation should be performed before a procedure to objectively confirm the diagnosis and establish symptom correlation. • Currently laparoscopic fundoplication is the gold standard for surgical intervention of GERD. There is no consensus on which is the best approach. • Post-operative dysphagia is the most commonly reported complication (often transient); followed by gas bloat syndrome.
Conclusion • The initial clinical experience with LINX (magnetic sphincter augmentation) has produced promising results in patients with moderate GERD ± small hiatus hernia in short- and medium-term. • Currently, the usage of endoscopic therapy or trans-oral incisionless fundoplication cannot be recommended as an alternative to medical or traditional surgical therapy. • RFA (Stretta) lacks sustainable efficacy • EsophyX awaits medium- and long-term data
References (1) • Vakil N, van Zanten SV, Kahrilas P, et al. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol 2006;101(8):1900–20 • Singhal V, Khaitan L. Preoperative evaluation of gastroesophageal reflux disease. Surg Clin North Am. 2015 Jun;95(3):615-27. • Yates RB, Oelschlager BK. Surgical treatment of gastroesophageal reflux disease. Surg Clin North Am. 2015 Jun;95(3):527-53. • Attwood SE, Galmiche JP. “A debate on the roles of antireflux surgery and long-term acid suppression in themanagement of gastroesophgeal reflux disease,” Frontline Gastroenterology, vol. 2, no. 4, pp. 206–211, 2011. • Stefanidis D, Hope WW, Kohn GP et al. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg Endosc 2010; 24: 2647-2669 [SAGES guideline] • Fuchs KH, Babic B, Breithaupt W, et al; European Association of Endoscopic Surgery (EAES). EAES recommendations for the management of gastroesophageal reflux disease. Surg Endosc. 2014 Jun;28(6):1753-73. • Chang EY, Morris CD, et al. The effect of antireflux surgery on esophageal carcinogenesis in patients with barrett esophagus: a systematic review. Ann Surg. 2007 Jul;246(1):11-21. • Shaheen NJ, et al; American College of Gastroenterology. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. 2016 Jan;111(1):30-50. • Qu H, Liu Y, He QS. Short- and long-term results of laparoscopic versus open anti-reflux surgery: a systematic review and metaanalysis of randomized controlled trials. J Gastrointest Surg 2014; 18: 1077-1086 • Moore M, Afaneh C, Benhuri D, et al. Gastroesophageal reflux disease: A review of surgical decision making. World J Gastrointest Surg 2016; 8(1): 77-83
References (2) • Garg SK, Gurusamy KS. Laparoscopic fundoplication surgery versus medical management for gastro-oesophageal reflux disease (GORD) in adults. Cochrane Database Syst Rev 2015; 11:CD003243. • Galmiche JP, Hatlebakk J, Attwood S, et al; LOTUS Trial Collaborators. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA. 2011 May 18;305(19):1969-77. • Grant AM, Cotton SC, Boachie C, et al; REFLUX Trial Group. Minimal access surgery compared with medical management for gastro-oesophageal reflux disease: five year follow-up of a randomised controlled trial (REFLUX). BMJ. 2013 Apr 18;346:f1908. • Broeders JA, Mauritz FA, Ahmed Ali U, et al. Systematic review and meta-analysis of laparoscopic Nissen (posterior total) versus Toupet (posterior partial) fundoplication for gastrooesophageal reflux disease. Br J Surg 2010; 97: 1318-1330 • Broeders JA, Roks DJ, Ali U, et al. Laparoscopic anterior versus posterior fundoplication for gastro-esophageal reflux disease: systemic review and meta-analysis of randomized clinical trials. Ann Surg. 2011; 254 (1): 39-47 • Dallemagne B, Weerts J, Markiewicz S, et al. Clinical results of laparoscopic fundoplication at ten years after surgery. Surg Endosc 2006; 20: 159-165 • Dominitz JA, Dire CA, Billingsley KG, Todd-Stenberg JA. Complications and antireflux medication use after antireflux surgery. Clin Gastroenterol Hepatol 2006; 4:299. • Kessing BF, Broeders JAJL, Vinke N, et al. Gas-related symptoms after antireflux surgery. Surg Endosc 2013;27(10):3739–47. • Zhou T, Harnsburger C, Broderick R, et al. Reoperation rates after laparoscopic fundoplication. Surg Endosc 2015 Mar; 29(3): 510-514
References (3) • Lipham JC, DeMeester TR, Ganz RA, et al. The LINXs reflux management system: confirmed safety and efficacy now at 4 years. Surg Endosc. 2012;26:2944–2949. • Ganz RA, Peters JH, Horgan S, et al. Esophageal sphincter device for gastroesophageal reflux disease. N Engl JMed. 2013;368:719–727 • Ganz RA, Edmundowicz SA, Taiganides PA, et al. Long-term Outcomes of Patients receiving a Magnetic Sphincter Augmentation Device for gastroesophageal reflux. Clin Gastroenterol Hepatol. 2016; 14(5): 671-677 • Zhang H, Dong D, Liu Z, et al. Revaluation of the efficacy of Magnetic Sphincter Augmentation for treating gastroesophageal reflux disease. Surg Endosc 2015 Dec 10 (Epub) • Hummel K, Richards W. Endoscopic Treatment of gastroesophageal reflux disease. Surg Clin N Am 2015; 95: 653-667 • Perry K, Banerjee A, Melvin WS, et al. Radiofrequency energy delivered to lower esophageal sphincter reduces esophageal acid exposure and improves GERD symptoms: a systematic review and meta-analysis. Surg Laparosc Endosc Percutan Tech 2012;22(4):283–8. • Wendling MR, Melvin S, Perry KA. Impact of transoral incisionless fundoplication (TIF) on subjective and objective indices: a systematic review of the published literature. Surg Endosc 2013;27:3754–61. • Trad K, Barnes WE, Simoni G, et al. Transoral incisionless fundoplication effective in eliminating GERD symptoms in partial responders to proton pump inhibitor therapy at 6 months: the TEMPO randomized clinical trial. Surg Innov 2015; 22(1):26–40.
Lower esophageal sphincter (LES) Zone of high pressure located just above EGJ • Intrinsic musculature of the distal esophagus • Sling fibers of the gastric cardia • Diaphragmatic crura at the esophageal hiatus • Intra-abdominal pressure exerted on EGJ Yates RB. Surgical treatment of GERD, 2015
Anti-reflux Surgery vs. Medical treatment Attwood SE, 2011
DeMeester score • Total esophageal acid exposure time • Upright acid exposure time • Supine acid exposure time • Number of episodes of reflux • Number of reflux episodes lasting more than 5 minutes • The duration of the longest reflux episode
Can anti-reflux surgery prevent malignancy in Barrett’s esophagus (BE)? • Systemic review 1 : ARS could be associated with regression of Barrett’s esophagus and/or dysplasia (low level of evidence) • Very low incidence of malignancy in non-dysplastic BE (3.3/1000 person-years) 2 In the setting of BE, ARS is indicated for uncontrolled GERD symptoms or esophagitis, but NOT as an anti-neoplastic measure 2 1. Chang EY. Effect of ARS on esophageal carcinogenesis in BE, 2007 2. ACG Clinical Guideline on diagnosis & management of BE, 2016.
Anti-reflux Surgery – Laparoscopic vs. Open • Meta-analysis of 12 RCTs (patient number 1,067) • Faster convalescence↓hospital stay and sick leave • Safer↓complication rates in both short -term (OR 0.31, 95% CI 0.17-0.56) and long-term (OR 0.24, 95 % CI 0.07 -0.80) • Better control of reflux symptoms in the long-term period (P < 0.05) • ↓heartburn (LAR 12.9 vs. 18.8 %) • ↓dysphagia (LAR 6.8 vs.11.0 %) • Comparable reoperation rate, patient’s satisfaction and 24-hr pH monitoring Qu H. LARS vs OARS meta-analysis, 2014 Long-term reflux symptoms
Anti-reflux Surgery – Operative complications • Pneumothorax (2%) • Gastric and esophageal injuries (1%) • Splenic injury/ bleeding (2%) • Vascular injury – IVC, left hepatic vein, aorta