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• W2562835141 abstract "In this issue of Gastrointestinal Endoscopy, Khashab et al1Khashab M.A. Ngamruengphong S. Carr-Locke D. et al.Gastric per-oral endoscopic myotomy for refractory gastroparesis: results from the first multicenter study on endoscopic pyloromyotomy (with video).Gastrointest Endosc. 2017; 85: 123-128Abstract Full Text Full Text PDF Scopus (135) Google Scholar present data from the first multicenter study of endoscopic pyloromyotomy for gastroparesis; there were 2 centers in the United States and 1 center each in India, Brazil, and Korea. Gastroparesis is a syndrome of significantly delayed gastric emptying in the absence of mechanical obstruction and cardinal symptoms that include early satiety, postprandial fullness, nausea, vomiting, bloating, and upper-abdominal pain.2Camilleri M. Parkman H.P. Shafi M.A. et al.Clinical guideline: management of gastroparesis.Am J Gastroenterol. 2013; 108: 18-38Crossref PubMed Scopus (698) Google Scholar Diabetes, postsurgical, idiopathic, and postviral gastroparesis are the most commonly associated conditions; more rarely, gastroparesis is associated with other conditions such as extrinsic neurologic disorders including Parkinsonism, paraneoplastic disease, and early scleroderma.2Camilleri M. Parkman H.P. Shafi M.A. et al.Clinical guideline: management of gastroparesis.Am J Gastroenterol. 2013; 108: 18-38Crossref PubMed Scopus (698) Google Scholar, 3Goldblatt F. Gordon T.P. Waterman S.A. Antibody-mediated gastrointestinal dysmotility in scleroderma.Gastroenterology. 2002; 123: 1144-1150Abstract Full Text Full Text PDF PubMed Scopus (114) Google Scholar There continues to be a significant unmet need for patients with gastroparesis, requiring prescribers of current medications to balance their attempts to relieve patients’ symptoms with the potential for litigation in view of the black box warning by the U.S. Food and Drug Administration (FDA) about the risk of tardive dyskinesia and the admonition to prescribe the sole approved drug for gastroparesis for only 3 months, despite evidence that the disease may persist more than 25 years. The rationale for interventions on the pylorus is based on the observation of pylorospasm in patients with gastroparesis. There is reduced expression of neuronal nitric oxide synthase in the pylorus of nonobese diabetic mice when they develop diabetes; the reduced expression is reversed by insulin treatment4Watkins C.C. Sawa A. Jaffrey S. et al.Insulin restores neuronal nitric oxide synthase expression and function that is lost in diabetic gastropathy.J Clin Invest. 2000; 106: 373-384Crossref PubMed Scopus (221) Google Scholar and with the phosphodiesterase-5 inhibitor sildenafil (which increases intracellular cyclic guanosine monophosphate (cGMP) and mimics the effect of nitric oxide). Unfortunately, sildenafil had no significant effect on gastric emptying in gastroparesis associated with uremia.5Dishy V. Cohen Pour M. Feldman L. et al.The effect of sildenafil on gastric emptying in patients with end-stage renal failure and symptoms of gastroparesis.Clin Pharmacol Ther. 2004; 76: 281-286Crossref PubMed Scopus (32) Google Scholar Prior literature has documented interventions on the pylorus in patients with gastroparesis (summarized elsewhere with all pertinent references6Camilleri M. Novel diet, drugs, and gastric interventions for gastroparesis.Clin Gastroenterol Hepatol. Epub 2016 Jan 4; Google Scholar) including these:1.Intrapyloric injection of botulinum toxin, which directly inhibits the smooth muscle contractile response to acetylcholine, has been described.7James A.N. Ryan J.P. Parkman H.P. Inhibitory effects of botulinum toxin on pyloric and antral smooth muscle.Am J Physiol. 2003; 285: G291-G297Crossref PubMed Scopus (63) Google Scholar A recent guideline on gastroparesis reviewed all of the data on efficacy.2Camilleri M. Parkman H.P. Shafi M.A. et al.Clinical guideline: management of gastroparesis.Am J Gastroenterol. 2013; 108: 18-38Crossref PubMed Scopus (698) Google Scholar On the basis of the results of the randomized controlled trials comparing botulinum toxin with sham/placebo injection, the guideline did not recommended the intrapyloric injection of botulinum toxin for patients with gastroparesis.2Camilleri M. Parkman H.P. Shafi M.A. et al.Clinical guideline: management of gastroparesis.Am J Gastroenterol. 2013; 108: 18-38Crossref PubMed Scopus (698) Google Scholar In contrast, small observational studies have suggested that intrapyloric botulinum toxin can improve both gastric emptying and symptoms, and a retrospective, single-center, open-label study of 179 patients reported decreased symptoms of gastroparesis 1 to 4 months after the intrapyloric injection of botulinum toxin in 51.4% of patients, with greater benefit observed with a 200-unit dose versus a 100-unit dose, female gender, age <50 years, and idiopathic gastroparesis. Moreover, a clinical response to a second injection was observed in 73.4% of evaluable patients.2.Endoscopic placement of a through-the-scope, double-layered, fully covered Niti-S self-expandable metal transpyloric stent, which is anchored by suturing on the gastric side, has been tested in small open-label studies, typically in patients with refractory gastroparesis. Technical success was achieved during 98% of procedures. Although the data are incomplete, there were improvements in gastric emptying and clinical outcomes in 75% of patients with adequate follow-up; greater efficacy was observed in those with predominant nausea, vomiting, or both (79% response) rather than in those with predominant pain (21% response).3.Laparoscopic pyloroplasty was evaluated in a retrospective study of 46 patients: gastric emptying normalized in 60%, and there was a reduction in symptom severity for all 9 categories and in total symptom score on the Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD).4.Gastric peroral endoscopic myotomy (G-POEM), sometimes with laparoscopic guidance, has been described in individual case reports, including patients with idiopathic or postsurgical gastroparesis. At 30 days’ follow-up, clinical benefit (improvement of nausea and epigastric burning, but not of vomiting, early satiety, postprandial fullness, or pain) and enhanced gastric emptying were recorded. In the reported multicenter, retrospective review of medical records, 30 patients with refractory gastroparesis (11 diabetic, 12 postsurgical, 7 idiopathic) underwent G-POEM. Prior therapies included metoclopramide in 97% of patients, erythromycin in 23%, and domperidone in 67%, and 53% (n=16) had prior endoscopic interventions: botox injection in 12 patients, transpyloric stenting in 3, and percutaneous endoscopic gastrojejunostomy in 1. Nausea and vomiting were the predominant symptoms in 26 patients (86%), and 18 (60%) had undergone hospitalization for gastroparesis symptoms. Weight loss was present in 27 patients, with an average of 10% of body weight loss, but body mass index was not reported. According to the clinical characterization of patients with idiopathic gastroparesis, almost half are overweight or obese, underscoring the continued vexing problem of distinguishing those with true gastroparesis from those with functional dyspepsia.8Parkman H.P. Yates K. Hasler W.L. et al.Clinical features of idiopathic gastroparesis vary with sex, body mass, symptom onset, delay in gastric emptying, and gastroparesis severity.Gastroenterology. 2011; 140: 101-115Abstract Full Text Full Text PDF PubMed Scopus (230) Google Scholar Although gastric emptying delay was documented by 4-hour gastric emptying scintigraphy (GES) (retention 37% + 23%), it is unclear whether the method used was standardized across centers. The cause of the postsurgical gastroparesis is unclear, although the reader can be reassured that these were patients who had not undergone prior distal gastrectomy (Billroth I or II) or pyloric interventions. The G-POEM was completed successfully in all 30 (100%) patients, with a mean procedure time of 72 minutes and a mean length of hospital stay of 3.3 days (range, 1-12 days). Adverse events occurred in 2 (6.7%) patients, including 1 capnoperitoneum and 1 prepyloric ulcer, and were rated as mild and severe, respectively. Clinical response was defined as a reduction in a patient’s self-reported gastroparetic symptoms with absence of recurrent hospitalizations. Changes in symptoms after G-POEM were reported as “resolution of symptoms, improved but not resolved, unchanged, or worse.” Clinical response was observed in 26 (86%) patients during a median follow-up time of 5.5 months. Four patients (2 diabetic, 1 postsurgical, 1 idiopathic cause) did not respond to G-POEM. Although the assessment of responsiveness was somewhat useful for an initial pilot study, it is clear that more robust appraisal with the use of accepted patient response outcomes will be required in future studies, as recommended by the FDA in a guidance document9http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM455645.pdf.Google Scholar and further discussed in a publication from the American Gastroenterological Association.10http://www.gastro.org/news_items/2015/9/15/aga-comments-on-fda-draft-guidance-on-gastroparesis-drugs.Google Scholar Previous reliance on such subjective measures in this field have demonstrated that even patients undergoing completion gastrectomy for refractory gastroparesis have reported subjective “improvement” of their health status, even though they continued to receive total parenteral nutrition to maintain their nutritional status.11Forstner-Barthell A.W. Murr M.M. Nitecki S. et al.Near-total completion gastrectomy for severe postvagotomy gastric stasis: analysis of early and long-term results in 62 patients.J Gastrointest Surg. 1999; 3 (discussion 21-3): 15-21Crossref PubMed Google Scholar Effects on gastric emptying, appraised by repeated GES, were obtained for 17 patients: normalized in 8 (47%) and improved in 6 (35%) patients. The mean repeated 4-hour gastric retention was 17% in those who underwent the test. Unfortunately, not all patients underwent the gastric emptying test, and the change in gastric retention at 4 hours in each participant with paired studies is unclear. Although the mean difference in gastric retention between baseline and post-POEM determinations was 20% (37% to 17%), one cannot assume that this benefit is generalizable, and the baseline gastric retention at 4 hours was not a predictor of responsiveness to therapy. A prior review6Camilleri M. Novel diet, drugs, and gastric interventions for gastroparesis.Clin Gastroenterol Hepatol. Epub 2016 Jan 4; Google Scholar examined the pathophysiologic factors potentially influencing the outcomes of G-POEM for gastroparesis. Different meals are emptied from the stomach at different rates, based on their physical consistency, fat content, and total caloric load. Liquids with a higher caloric content and homogenized solids empty almost linearly under the pressure gradient from the fundus and coordinated antropyloroduodenal motility. Digestible food of more solid consistency requires antral trituration by effective antral contractions until the particle size is reduced to <2 mm; after trituration occurs, food empties linearly from the stomach at a rate similar to that of a homogenized solid meal. In gastroparesis, there is abnormal function of smooth muscle and of enteric and extrinsic vagal innervation, or the interstitial cells of Cajal (ICC), which act as pacemakers in the stomach wall. The delay of gastric emptying in gastroparesis is associated with distal antral hypomotility, pylorospasm, or intestinal dysmotility.12Camilleri M. Bharucha A.E. Farrugia G. Epidemiology, mechanisms, and management of diabetic gastroparesis.Clin Gastroenterol Hepatol. 2011; 9: 5-12Abstract Full Text Full Text PDF PubMed Scopus (196) Google Scholar In general, antral hypomotility is usually present when there is pylorospasm.13Mearin F. Camilleri M. Malagelada J.R. Pyloric dysfunction in diabetics with recurrent nausea and vomiting.Gastroenterology. 1986; 90: 1919-1925Abstract Full Text PDF PubMed Scopus (324) Google Scholar Decreased postprandial antral motility prolongs the gastric emptying time for solids by prolonging the lag duration and lowering the rate of postlag emptying; intestinal dysmotility retards the gastric emptying rate and may result in duodenogastric bile reflux (which would be expected to worsen with pyloroplasty). Unfortunately, the patients participating in this study did not undergo detailed appraisal of the motor dysfunctions such as antropyloroduodenal manometry. It is, therefore, unclear whether the lack of response in 4 of the patients reflected pylorospasm in addition to antral hypomotility or duodenal dysmotility. In addition, it is possible that the gastroparesis associated with vagal neuropathy associated with diabetes reflects a more severe form from that associated with abnormal function of the ICC or intrinsic neuropathy. Therefore, the selection of patients for G-POEM therapy is still based on trial and error, and it is hoped that future prospective, sham-controlled studies will include sufficient characterization, with at least standardized gastric emptying measurements before and after the procedure in all participants, as well as measurement of abdominal vagal function by plasma pancreatic polypeptide response to simulated feeding. The importance of a sham endosurgical control procedure in any future study of G-POEM cannot be overstated. Unlike POEM performed for achalasia, which can be compared with a Heller myotomy, there is not a criterion standard treatment for gastroparesis with which G-POEM can be compared; indeed, the treatment of gastroparesis, even at centers of excellence, is overall very disappointing.14Pasricha P.J. Yates K.P. Nguyen L. et al.Outcomes and factors associated with reduced symptoms in patients with gastroparesis.Gastroenterology. 2015; 149: 1762-1774.e4Abstract Full Text Full Text PDF PubMed Scopus (82) Google Scholar Although objective testing with GES is available, the correlation with symptoms is weak, and any assessment of the efficacy of G-POEM will have to rely on the inherently subjective measures of symptoms such as nausea and pain, which are prone to distortion by placebo responses. It will not be enough to show that G-POEM combined with standard dietetic and medical care results in significant improvement. Gastric electric stimulation for diabetic gastroparesis showed an impressive reduction in vomiting frequency; yet, there was no difference whether the device was turned “on” or “off.”15McCallum R.W. Snape W. Brody F. et al.Gastric electrical stimulation with Enterra therapy improves symptoms from diabetic gastroparesis in a prospective study.Clin Gastroenterol Hepatol. 2010; 8: 947-954Abstract Full Text Full Text PDF PubMed Scopus (155) Google Scholar For all of these reasons, only a sham-controlled study can move the field forward and prevent a lost decade of desperate patients being treated with a novel intervention that is not truly effective. With respect to patient safety, a sham G-POEM procedure would presumably entail anesthesia and EGD, but we doubt that this would exceed the risks of other accepted research interventions such as muscle biopsy and bronchoscopy.16Horng S. Miller F.G. Is placebo surgery unethical?.N Engl J Med. 2002; 347: 137-139Crossref PubMed Scopus (147) Google Scholar The authors conclude that G-POEM is technically feasible when applied in several centers. This small, nonrandomized, noncontrolled study suggests that G-POEM may be efficacious for the treatment of patients with gastroparesis refractory to medical therapy and that it results in normalization of gastric emptying in some patients. On the basis of these promising results, prospective and sham-controlled studies should include standardized patient response outcomes such as the GCSI-DD, standardized measurement of gastric emptying, appraisal of abdominal vagal function, and, in the centers with such capability, measurement of baseline antral and duodenal motility to help us start to understand the predictors of responsiveness. Such studies will guide the selection of patients most likely to respond to this invasive therapy. At present, it appears that those with isolated pylorospasm are the best candidates for G-POEM until proven otherwise. All authors disclosed no financial relationships relevant to this publication. Gastric per-oral endoscopic myotomy for refractory gastroparesis: results from the first multicenter study on endoscopic pyloromyotomy (with video)Gastrointestinal EndoscopyVol. 85Issue 1PreviewGastric per-oral endoscopic myotomy (G-POEM) recently has been reported as minimally invasive therapy for gastroparesis. The aims of this study were to report on the first multicenter experience with G-POEM and to assess the efficacy and safety of this novel procedure for patients with gastroparesis with symptoms refractory to medical therapy. Full-Text PDF" @default.
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