Gastric peroral pyloromyotomy (G-POP) is a minimally invasive endoscopic technique for treating refractory gastroparesis (GP). The functional luminal imaging probe (FLIP) is an endoscopic tool for measuring the physiologic parameters of the gastrointestinal sphincters. Here, FLIP was used to investigate the association between physiologic measurements of the pylorus and clinical outcomes after G-POP using the Gastroparesis Cardinal Symptom Index (GCSI) to monitor clinical response.

This was a single-center prospective study of 48 patients with GP who underwent G-POP for the management of refractory GP. The cross-sectional area, pressure, and distensibility index (DI) of the pylorus were evaluated using FLIP at 40-mL and 50-mL balloon fill volumes pre- and postprocedurally. GCSI scores were used to monitor clinical symptoms both preprocedurally and at 6 weeks after G-POP.

Technical success was achieved in 100% of patients. GCSI scores (0-5) decreased by an average of 0.95 ± 1.45 points at 6 weeks postoperatively, with the nausea/vomiting and bloating subscales showing the greatest improvement. The change (∆) in DI at 50-mL balloon fill volumes was a statistically significant predictor of symptomatic improvement after the procedure, with ∆DI at 50 mL of >1.5 mm2/mm Hg strongly correlated with larger improvements in GCSI (Pearson coefficient: 0.544; P =.036).

The EndoFLIP was not found to be a reliable predictor of clinical success before G-POP. However, measuring changes pre- and postprocedurally can be used to guide management. Additional investigations are needed to elucidate the relationship between physiologic pyloric sphincter measurements and clinical response to G-POP.

Pyloric dysfunction is defined as hypertonia or spasm of the pyloric sphincter. The pylorus plays a key role in gastric emptying, but its function remains incompletely understood. Most studies have focused on gastroparesis regardless of the underlying pathophysiology. Few studies have reported pyloric dysfunction in patients with gastroparesis, and the diagnostic and treatment modalities for pyloric dysfunction are not well established. Recently developed diagnostic modalities assessing pyloric function, such as high-resolution antroduodenal manometry and endoluminal functional lumen imaging, are currently being evaluated. A variety of therapeutic interventions targeting the pylorus, including pharmacologic agents, intrapyloric botulinum injection, endoscopic balloon dilation, stent insertion, surgical pyloroplasty, and gastric peroral endoscopic pyloromyotomy, have been proposed. Among these, gastric peroral endoscopic pyloromyotomy has emerged as a novel, minimally invasive therapy with demonstrated efficacy and safety for refractory gastroparesis. This article reviews the pathophysiology of pyloric dysfunction and the potential diagnostic and therapeutic modalities based on the latest literature.

Although gastric peroral endoscopic myotomy (G-POEM) has shown substantial efficacy in patients with medically refractory gastroparesis (GP), comprehensive long-term data on its effectiveness are lacking.

We conducted a systematic review and meta-analysis including observational studies assessing long-term efficacy after G-POEM in patients with refractory GP. Our primary outcome was the pooled rate of clinical success 1-year after G-POEM. Secondary outcomes included clinical success at 2 and 3 years and the rate of adverse events according to the American Society for Gastrointestinal Endoscopy classification.

Thirteen studies, involving 952 patients with refractory GP undergoing G-POEM, were eligible. The pooled 1 year-clinical success was 0.72 (95% confidence interval [CI]: 0.56, 0.85, I2 = 94.9%). The clinical success was 0.67 (95% CI: 0.47, 0.97, I2 = 95.8%) when considering only studies defining success as 1 point decrease in Gastroparesis Cardinal Symptoms Index score and at least 25% decrease in two subscales. For patients who had 1-year success, the pooled clinical success at 2 and 3 years were 0.71 (95% CI: 0.45, 0.92, I2 = 94.9%) and 0.58 (95% CI: 0.19, 0.92, I2 = 97.1%), respectively. The pooled rate of adverse events was 0.08 (95% CI: 0.06, 0.10, I2 = 0%).

G-POEM is associated with successful outcomes in about 70% of treated cases after 1 year, with durable long-term effects lasting up to 3 years. In the future, new uniform outcome definitions and strict patient selection criteria are warranted to delineate G-POEM outcomes more accurately.

Obesity is a global health concern, with intragastric balloon (IGB) placement serving as a nonsurgical intervention for weight management. However, intolerance due to severe gastrointestinal side effects often leads to premature removal, limiting its effectiveness. Botulinum toxin A (BTX-A) injection has been proposed as a potential strategy to improve IGB tolerance by modulating gastric motility.

This study reports a case series of patients who developed severe intolerance to IGB placement, including persistent nausea, vomiting, fluid intolerance, dehydration, and reduced urine output, necessitating medical intervention.

Patients were diagnosed with IGB intolerance due to obstructive gastric effects, characterized by impaired gastric emptying and intolerance to oral fluids, leading to dehydration and electrolyte imbalances.

A total of 14 patients with IGB intolerance were treated with 500 U of BTX-A injected around the pyloric canal. Prokinetic drugs were also administered to support gastric motility. Patients were monitored for 6 months following the intervention.

Among the 14 patients, 11 (78.57%) showed a significant improvement in fluid tolerance within 12 hours of BTX-A injection and were able to retain the IGB without additional complications. Three patients (21.43%) did not improve and required early IGB removal. No major adverse effects related to BTX-A injection were observed.

BTX-A injection appears to be a promising adjunctive therapy to improve IGB tolerance in patients experiencing severe intolerance. These findings suggest a potential role for BTX-A in reducing the need for premature balloon removal, thereby enhancing weight loss outcomes. However, further randomized controlled trials with larger sample sizes are needed to confirm its efficacy, optimize dosage, and establish standardized treatment protocols.

To establish a consensus on the definition and management of idiopathic gastroparesis, international experts (selected by neurogastroenterology and motility societies and initiated by the Rome Foundation) devised 144 statements using the Delphi method, with at least 80% agreement required. This consensus defined idiopathic gastroparesis as the presence of symptoms associated with delayed gastric emptying in the absence of mechanical obstruction. Nausea and vomiting were identified as cardinal symptoms. Frequently co-existing symptoms are early satiation and postprandial fullness. Diagnosis requires the presence of these symptoms alongside delayed gastric emptying, measured by a 4 h scintigraphy or gastric emptying breath test of a mixed composition meal in the absence of mechanical obstruction. Therapeutic options with proven efficacy were sparse. Dietary adjustments, nutritional support (per guidelines from the European Society for Clinical Nutrition and Metabolism for substantial weight loss or intractable vomiting), and opioid cessation were recommended by a consensus opinion. Antiemetic and prokinetic agents were also considered potentially beneficial. This consensus offers a global perspective on idiopathic gastroparesis.

Gastroparesis has a substantial impact on the quality of life but has limited treatment options, which makes it a public health concern. No bibliometric studies on gastroparesis have been published thus far. Thus, this article aims to summarize and analyze research hotspots to provide a reference for clinical researchers.

Gastroparesis-related research articles were searched in the Web of Science Core Collection (WOSCC), and relevant information was extracted after screening. A total of 1033 documents were analyzed with the bibliometric method using Microsoft Excel, Citespace, and VOSviewer.

Overall, our search retrieved 1033 papers contributed by 966 research institutions from 53 countries. Since 1980, publications in this field have increased rapidly. United States (n = 645) and Temple University (n = 122) were the most productive country and institution, respectively. Parkman, with 96 publications, was the most prominent author.

Research hotspots in gastroparesis can be summarized into four domains: innovation in diagnostic modalities, change of oral therapeutic agents, choice of surgical interventions, and pathological mechanisms. Future research on gastroparesis should focus on the quality of life of patients, diagnostic techniques, pyloromyotomy, and transpyloric stent placement.

Gastroparesis (GP) is a chronic disease characterized by upper gastrointestinal symptoms, primarily nausea and vomiting, and delayed gastric emptying (GE), in the absence of mechanical GI obstruction. The underlying pathophysiology of GP remains unclear, but factors contributing to the condition include vagal nerve dysfunction, impaired gastric fundic accommodation, antral hypomotility, gastric dysrhythmias, and pyloric dysfunction. Currently, gastric emptying scintigraphy (GES) is considered the gold standard for GP diagnosis. However, the overall delay in GE weakly correlates with GP symptoms and their severity. Recent research efforts have focused on developing treatments that address the presumed underlying pathophysiological mechanisms of GP, such as pyloric hypertonicity, with Gastric Peroral Endoscopic Myotomy (G-POEM) one of these procedures. New promising diagnostic tools for gastroparesis include wireless motility capsule (WMC), the 13 carbon-GE breath test, high-resolution electrogastrography, and the Endoluminal Functional Lumen Imaging Probe (EndoFLIP). Some of these tools assess alterations beyond GE, such as muscular electrical activity and pyloric tone. These modalities have the potential to characterize the pathophysiology of gastroparesis, identifying patients who may benefit from targeted therapies. The aim of this review is to provide an overview of the current knowledge on diagnostic pathways in GP, with a focus on the association between diagnosis, symptoms, and treatment.

Diabetic gastroparesis carries a heavy burden on people with diabetes and the healthcare system. It remains underdiagnosed and represents challenges to treat. This article reviews the epidemiology, pathophysiology, clinical features, diagnosis and treatment of diabetic gastroparesis. The disorder is characterized by delayed gastric emptying without evidence of mechanical gastric outflow obstruction. It presents with upper gastrointestinal (GI) symptoms such as nausea, vomiting, early satiety, postprandial fullness, upper abdominal discomfort and or bloating. As the prevalence of diabetes has been growing over the last few decades, we would expect an increased incidence of delayed gastric emptying in poorly controlled diabetes and perhaps in line with the increasing use of medications that act on the GI tract such as incretin-based therapy. The disease results from multiple reversible and irreversible mechanisms. Diagnosing diabetic gastroparesis requires careful history, examination and investigations to exclude other disorders that could mimic its clinical presentation. Treatment involves a wide variety of options starting with optimization of glycaemic control, stopping any offending medications and lifestyle modifications followed by the introduction of medical therapeutics such as prokinetics. Then, surgical interventions are considered in refractory cases.

BACKGROUND : Patients with gastroparesis who have undergone prior intrapyloric botulinum toxin injection (BTI) may seek an opinion regarding peroral pyloromyotomy (POP). There are only two small reports assessing the role of BTI as a predictor for successful treatment with POP.

We performed a retrospective cohort study to assess whether symptomatic improvement after BTI predicts a response to POP. We included 119 patients who had undergone both BTI and POP at Cleveland Clinic Ohio or Cleveland Clinic Florida from January 2016 to September 2019.

65.5 % of patients had symptomatic improvement after BTI. Gastroparesis Cardinal Symptom Index (GCSI) scores were available for 74 patients, with 64 % achieving a response to POP, defined as a decrease in mean GCSI ≥ 1. In multivariable analysis, response to BTI (odds ratio [OR] 7.7 [95 %CI 2.2-26.1]) and higher pre-POP GCSI score (OR 2.3 [95 %CI 1.2-4.6]) were independent predictors of response to POP.

Clinical improvement after BTI is a predictor of response to POP in patients with gastroparesis. This information may aid in improving patient selection for POP.

Although pediatric neurogastroenterology and motility (PNGM) disorders are prevalent, often debilitating, and remain challenging to diagnose and treat, this field has made remarkable progress in the last decade. Diagnostic and therapeutic gastrointestinal endoscopy emerged as a valuable tool in the management of PNGM disorders. Novel modalities such as functional lumen imaging probe, per-oral endoscopic myotomy, gastric-POEM, and electrocautery incisional therapy have changed the diagnostic and therapeutic landscape of PNGM. In this review, the authors highlight the emerging role of therapeutic and diagnostic endoscopy in esophageal, gastric, small bowel, colonic, and anorectal disorders and disorders of gut and brain axis interaction.

Gastroparesis is a gastric motility disorder characterized by delayed gastric emptying. It is a rare disease and difficult to treat effectively; management is a dilemma for gastroenterologists and surgeons alike. We conducted a systematic review of the literature to evaluate current diagnostic tools as well as treatment options. We describe key elements in the pathophysiology of the disease, in addition to current evidence on treatment alternatives, including nutritional considerations, medical and surgical options, and related outcomes.

Pyloroplasty and gastric peroral endoscopic myotomy (G-POEM) are effective surgeries for gastroparesis. The primary aim of this study was to evaluate outcomes of pyloroplasty and G-POEM in patients with gastroparesis and determine factors associated with favorable outcome. The secondary aim was to assess the utility of clinical response to preoperative pyloric dilation or botulinum toxin injection (Botox) on surgical outcome, a factor conventionally used as a favorable marker.

There were 204 patients who underwent pyloroplasty (n = 177) or G-POEM (n = 27) for gastroparesis at our institution from 2014 to 2021. Demographic and clinical parameters were analyzed to assess their impact on surgical outcome. A subgroup of patients who had pyloric dilation or Botox injection were assessed separately. Favorable outcome was defined as patient reported complete resolution of the predominant gastroparesis symptom.

Favorable outcome was achieved in 78.4% of patients (pyloroplasty: 79.7% and G-POEM: 70.4%, p = 0.274). Among 61 patients where pre- and postoperative gastric emptying studies (GES) were available, mean 4-hour retention significantly improved from 33.5 to 15.0% (p < 0.001) and 77.0% of patients achieved normalization. Favorable outcome was not significantly impacted by etiology of gastroparesis (p = 0.120), GERD (p = 0.518), or primary gastroparesis symptom (p = 0.244). Age ≥ 40 was a significant predictor of favorable surgical outcome on multivariate analysis [OR: 2.476 (1.224-5.008), p = 0.012]. Among the patients who had preoperative dilation (n = 82) or Botox injection (n = 46), response to these interventions was not a predictor of favorable surgical outcome (p = 0.192 and 0.979, respectively). However, preoperative Botox injection, regardless of response to injection, was associated with favorable surgical outcome [OR: 3.205 (CI 1.105-9.299), p = 0.032].

Symptomatic improvement after pyloroplasty or G-POEM is independent of etiology of gastroparesis, GERD, and primary symptom. Response to dilation or Botox are not markers of response to surgery. However, patients who receive Botox are 3.2 times more likely to improve postoperatively.

The pylorus plays a key role in the control of gastric content outflow. Impairment of pyloric physiology has been observed in gastroparesis, particularly when associated with diabetes mellitus or opioid intake or after antireflux surgery. New tools have been developed to identify pyloric dysfunction in routine care, including functional luminal impedance planimetry (FLIP). As such, a new therapeutic strategy targeting the pylorus, namely endoscopic pyloromyotomy (G-POEM), has received increasing attention and emerged as a promising treatment for gastroparesis.

The present review details the involvement of the pyloric pathophysiology in gastroparesis, as well as clinical results of G-POEM according to the current literature.

Patients with esophageal cancer undergoing esophagectomy have an improved survival over time, however adverse events associated with the use of a gastric conduit are increasingly being reported. Delayed gastric emptying (DGE) is an esophagectomy-related complication which can decreased quality of life by causing debilitating gastrointestinal symptoms and malnutrition. The aim of our study was to evaluate the effect of endoscopic intrapyloric botulinum (BT) injection in combination with pyloric balloon dilation in patients with DGE following distal esophagectomy at our tertiary cancer center. Patients with a prior history of distal esophagectomy who had also undergone endoscopic BT injection with pyloric balloon dilation by a single endoscopist between 2007 and 2017 were included in the study. One hundred units of BT were injected endoscopically into the pylorus in four quadrants using an injection needle. Following BT injection, a standard through-the-scope balloon was passed to the pylorus and inflated to a maximum diameter of 12−20 mm. For patients who underwent repeat procedures, the symptomatic outcomes were assessed and documented by the endoscopist; for the other patients, the electronic medical records were reviewed. A total of 21 patients undergoing 44 endoscopic intrapyloric botox injections combined with balloon dilatations were identified. The patients underwent the procedures at a median of 22 months (range, 1−108 months) after esophagectomy. The procedures were performed only once in 43% of the patients; 43% patients underwent the procedure twice, while 14% had it multiple times (>2). Overall, intrapyloric BT injection coupled with balloon dilation was a safe procedure, without any major immediate or delayed (1 month) procedure-related adverse events. Eighteen patients (85%) reported a significant overall improvement in symptoms from the initial presentation. One patient (5%) showed no improvement, whereas in two (10%) patients responses were not available. In our particular cohort of patients, the interventions of endoscopic intrapyloric BT injection with pyloric balloon dilation proved to be very beneficial, leading to significant symptomatic improvement. The balloon dilation after BT injection might have resulted in better diffusion of the BT into the pyloric sphincter complex, possibly increasing its therapeutic effects. Further prospective studies are needed to validate these results.

Intrapyloric botulinum toxin injection (IPBI) is used to treat nausea and vomiting in children, but no prospective pediatric studies exist. The aims of the current study were to assess the efficacy of IPBI in children with refractory nausea or vomiting and to use EndoFLIP as a biomarker of IPBI response.

This was a prospective observational cohort study of pediatric patients undergoing IPBI for refractory nausea, vomiting, or feeding difficulties at a tertiary center. Patients completed validated questionnaires at baseline and 1, 2, and 3 months after IPBI. A subset of patients >10 years old underwent pyloric EndoFLIP at the time of IPBI. Symptoms were compared pre- and post-IPBI, and EndoFLIP measurements were assessed in relation to baseline characteristics and response to IPBI.

Forty-five patients (mean age 14.2 ± 6.0 years) received IPBI, and 23 of those patients underwent EndoFLIP. Twenty-nine patients (64%) had symptomatic improvement at 1-month follow-up, including improvements in overall GI symptoms (p = 0.003), nausea and vomiting (p = 0.009), and discomfort when eating (p = 0.006). Symptomatic improvements lasted up to 3 months. There was a trend towards lower pyloric distensibility in patients with delayed versus normal gastric emptying (4.5 ± 3.8 mm2 /mmHg in delayed vs. 8.9 ± 6.6 mm2 /mmHg in normal, p = 0.09), though there were no differences in EndoFLIP measurements between IPBI responders and non-responders (p > 0.05).

The majority of patients responded to IPBI, with significant improvements seen in nausea, vomiting, and discomfort. Pyloric EndoFLIP tended to distinguish baseline delays in gastric emptying, but it did not predict IPBI response in this patient cohort.

There has been interest in the use of pyloric therapies for the treatment of refractory gastroparesis. However, data on endoscopic pyloric dilation are scarce. We aimed to assess the efficacy and safety of this procedure in refractory gastroparesis.

We performed a retrospective analysis of 47 patients referred for refractory gastroparesis, confirmed by gastric emptying scintigraphy, and treated with endoscopic pyloric through-the-scope balloon dilation. The primary endpoint was the effectiveness of the procedure, evaluated with the Gastric Cardinal Symptom Index (GCSI) at 2 and 6 months.

A clinical response, defined by a 1.0 point decrease in the GCSI score, was observed in 25 patients at 2 months (53%) and in 19 patients at 6 months (40%). The mean GCSI score decreased significantly at 2 and 6 months compared to the preoperative score (3.9 ± 0.87 vs 2.3 ± 1.37 and 3.9 ± 0.87 vs 2.9 ± 1.27, respectively; p < 0.0001). No complication was observed. Nine patients had a delayed relapse at 1 year. A second dilation was performed for eight patients and it was effective in five of them (63%). The mean follow-up time of the patients was 27.0 ± 10.4 months. At 2 years, 15 patients still experienced improvement following this treatment (32%). No predictive factor of clinical response was identified.

The efficacy of pyloric dilation is 53% at 2 months, with sustained improvement in one third of patients at 2 years. This treatment should be considered as an alternative option to pyloromyotomy.

Gastric emptying delay may be caused with both functional and anatomic derangements. Gastroparesis is suspected in patients presenting with certain foregut symptoms without anatomic obstruction. Data are still emerging regarding the best treatment of this condition. In cases where large paraesophageal hernias alter the upper gastrointestinal anatomy, it is difficult to know if gastroparesis also exists. Management of hiatal hernias is also still evolving, with various strategies to reduce recurrence being actively investigated. In this article, we present a systematic review of the existing literature around the management of gastroparesis and the management of paraesophageal hernias when they occur separately. In addition, since there are limited data to guide diagnosis and management of these conditions when they are suspected to coexist, we provide a rational strategy based on our own experience in patients with paraesophageal hernias who have symptoms or studies that raise suspicion for a coexisting functional disorder.

The incidence of adenocarcinoma of esophageal-gastric junction (AEJ) has been increasing in recent years. Esophagogastrostomy after proximal gastrectomy (PG-EG) is the most commonly used surgical method for this disease which causes a constant spasm of the pyloric sphincter by cutting the vagus nerve around the esophagus, so H-M pyloroplasty (Heineke-Mikulicz pyloroplasty) is often operated after PG-EG to prevent delayed gastric emptying. However, H-M pyloroplasty destroys anti-reflux structure of pylorus and leads to serious bile reflux. The present study was designed to compare pyloromyotomy and H-M pyloroplasty in proximal subtotal gastrectomy through clinical studies and animal experiments.

We retrospectively evaluated the outcomes of 73 AEJ patients (39 underwent PG-EG with an H-M pyloroplasty and 34 underwent PG-EG with a pyloromyotomy) between January 2016 and August 2020, and perioperative variables were compared. In the animal experiment, 48 rats were randomly divided into four groups (n = 12): vagotomy group (V group), H-M pyloroplasty group (HM group), pyloromyotomy group (PM group), and control group (O group). Gastric emptying and bile reflux were evaluated in each group.

In the retrospective clinic study, pyloromyotomy and H-M pyloroplasty could all prevent delayed gastric emptying effectively, and the incidence of bile reflux found by electronic gastroscopy in the PM group was significantly lower than that in the HM group (HM, 14/39; PM, 4/34; P = 0.028). In the animal experiment, there was no significant between-group difference of gastric emptying rate (%) in the HM group and PM group (HM, 70.6 ± 16; PM, 72.3 ± 12; P = 0.68) while the gastric emptying rate (%) was significantly lower in the V group than in the HM, PM, and control group (P values were 0.037, 0.021, and 0.001 respectively). The gastric mucosa bile acid concentration was significantly higher in the HM group than other group (P values were all less than 0.001).

The pyloromyotomy could prevent delayed gastric emptying effectively after PG-EG for types II and III AEJ and reduce bile reflux compared to Heineke-Mikulicz pyloroplasty.

Delayed gastric emptying (DGE) occurs in up to 40% of patients after esophageal resection and prolongs recovery and hospital stay. Surgically pyloroplasty does not effectively prevent DGE. Recently published methods include injection of botulinum toxin (botox) in the pylorus and mechanical interventions as preoperative endoscopic dilatation of the pylorus. The aim of this study was to investigate the efficacy of those methods with respect to the newly published Consensus definition of DGE.

A systematic literature search using CENTRAL, Medline, and Web of Science was performed to identify studies that described pre- or intraoperative botox injection or mechanical stretching methods of the pylorus in patients undergoing esophageal resection. Frequency of DGE, anastomotic leakage rates, and length of hospital stay were analyzed. Outcome data were pooled as odd's ratio (OR) or mean difference using a random-effects model. Risk of bias was assessed using the Robins-I tool for non-randomized trials.

Out of 391 articles seven retrospective studies described patients that underwent preventive botulinum toxin injection and four studies described preventive mechanical stretching of the pylorus. DGE was not affected by injection of botox (OR 0.87, 95% confidence interval [CI] 0.37-2.03, P = 0.75), whereas mechanical stretching resulted in significant reduction of DGE (OR 0.26, 95% CI 0.14-0.5, P < 0.0001).

Mechanical stretching of the pylorus, but not injection of botox reduces DGE after esophageal cancer resection. A newly developed consensus definition should be used before the conduction of a large-scale randomized-controlled trial.

Pyloric botulinum toxin injection has improved symptoms in children with delayed gastric emptying. We aimed to determine the clinical response to combined endoscopic intra-pyloric botulinum toxin injection and pyloric balloon dilation (IPBT-BD) in patients with dyspepsia.

Electronic medical records were reviewed to gather demographic data, symptoms, and follow-up on patients with dyspepsia. Cases were defined as those who underwent IPBT-BD in addition to their ongoing management. Controls received pharmacotherapy, behavioral intervention, or dietary management alone. Clinical response was defined as no change, partial, or complete improvement in symptoms within 12 months. Propensity score matching based on age, gender, and symptom duration was used to pair cases and controls.

In total, 79 cases and 83 controls were identified. After propensity matching, 63 patients were included in each group. The mean age for cases was 14.5 ± 3.9y; 62% were females and 98% were Caucasian. Further, 83% of 46 cases and 94% of 49 controls who had scintigraphy scans showed delayed gastric emptying. After matching, 76% of cases showed partial or complete improvement compared with 49% controls within 12 months (P = 0.004). Younger children tended to respond more favorably to the procedure (P = 0.08).

In our propensity-matched analysis, combined IPBT-BD in addition to pharmacotherapy, behavioral, or dietary management clearly showed a benefit over these modalities alone. This favorable response lasted up to 12 months.

(1) Background/aims: Intragastric botulinum toxin A injection (IGBI) combined with diet control is a new and effective weight loss method for grade 2 obese patients. However, the application of IGIB on overweight or obese adults still needs further research to confirm its efficacy. (2) Methods: We retrospectively collected medical data from 1 July 2021 to 1 January 2022 from a total of 71 patients without diabetes who participated in the bariatric clinic with a body mass index (BMI) > 25 kg/m2. Forty-nine participants opted for intragastric botulinum injection (IGBI) using 300 units of botulinum injected into the antrum, body, and fundus, followed with a low-calorie high-protein diet course. Another 22 people participated only in the low-calorie high-protein diet course as a placebo group. This study analyzes the weight loss percentage of the two groups. Adverse events after IGBI are also reported in a safety assessment. (3) Results: In terms of the characteristics of the two groups, the mean BMI was 29.3 kg/m2 in the IGBI group and 28.0 kg/m in the placebo group (p = 0.63 without significant difference). Comparing the percent weight loss from baseline in the two groups after 12 weeks, the IGBI group lost 11.5% of their body weight and the placebo group lost 1.8%. In terms of group analysis, the percentages of participants with a weight reduction of at least 5% for the IGBI and placebo groups were 95% and 4%, respectively. For weight reduction of at least 10%, these values for the IGBI and placebo groups were 63% and 4%, respectively. In terms of adverse events after IGBI for 12 weeks, 12 participants (24.4%) had constipation, which was the main side effect. No serious adverse events were observed during the study period. (4) Conclusion: The combination of a low-calorie high-protein diet and IGBI is an effective and safe procedure in overweight or obese adults for weight reduction, but further larger studies are needed.

Our tripartite narrative review discusses Peroral Endoscopic Myotomy (POEM), gastric POEM (GPOEM) and POEM for Zenker's diverticula (ZPOEM). POEM is the prototypical procedure that launched the novel "3rd space endoscopy" field of advanced endoscopy. It revolutionized achalasia therapy by offering a much less invasive version of the prior gold standard, the laparoscopic Heller myotomy (HM). We review in detail indications, outcomes, technique variations and comparative data between POEM and HM particularly with regard to the hotly debated issue of GERD. We then proceed to discuss two less illustrious but nevertheless important offshoots of the iconic POEM procedure: GPOEM for gastroparesis and ZPOEM for the treatment of hypopharyngeal diverticula. For GPOEM, we discuss the rationale of pylorus-directed therapies, briefly touch on GPOEM technique variations and then focus on the importance of proper patient selection and emerging data in this area. On the third and final part of our review, we discuss ZPOEM and expound on technique variations including our "ultra-short tunnel technique". Our review emphasizes that, despite the superiority of endoscopy over surgery for the treatment of hypopharyngeal diverticula, there is no clear evidence yet of the superiority of the newfangled ZPOEM technique compared to the conventional endoscopic myotomy technique practiced for over two decades prior to the advent of ZPOEM.

Delayed gastric emptying on objective testing defines gastroparesis, but symptoms overlap with functional dyspepsia and do not correlate well with gastric emptying delay. This review outlines a strategy for defining, diagnosing, and managing refractory gastroparesis.

The Best Practice Advice statements presented here were developed from review of existing literature combined with expert opinion to provide practical advice. Because this was not a systematic review, formal rating of the quality of evidence or strength of recommendations was not performed. BEST PRACTICE ADVICE.

Gastroparesis is a chronic stomach disorder and effective treatment is the aim of different strategies. Alternative therapies consist of an electrical stimulation of the stomach to evoke a response in the gastric activity. We present the development and in vivo application of an electromagnet system to induce a mechanical stimulus in the stomach aiming for gastric contractile responses.

The electromagnet system consisted of an implantable magnet and an external drive coil. We implanted the magnet at the greater curvature of the gastric body in rats. We applied an alternating current to the drive coils, inducing mechanical stimulation of the gastric wall. We measured the gastric contraction activity and gastric electrical activity in response to the stimulus using AC biosusceptometry and electrogastrography. Moreover, we used the phenol red to evaluate the stimulus effects on gastrointestinal transit.

The stimulus increased the spectral intensity and signal-to-noise ratio significantly of gastric contraction activity and gastric electrical activity. Furthermore, we found a lower phenol red retention in the stomach in rats without stimulus. No significant differences were found in frequency and root mean square amplitude.

We developed a new simple electromagnet system that evoked a contraction and gastric electrical response using a mechanical stimulus and decreased gastric emptying time. The system is an accessible tool and may contribute to gastroparesis studies in animals.

Diabetes mellitus remains a major public health problem throughout the United States with over $300 billion spent in total cost of care annually. In addition to being a leading cost of kidney failure, diabetes causes a host of secondary hyperglycemic-related complications including gastroparesis and orthostatic hypotension. While pancreas transplantation has been established as an effective treatment for diabetes, providing long-term normoglycemia in recipients, the secondary complications of diabetes mellitus persist complicating the post-operative course of an otherwise successful pancreas transplantation. This review describes the mechanism and impact of diabetic gastroparesis and orthostatic hypotension in the post-operative course of pancreas transplant patients and analyzes the various treatment modalities, based on current data and extensive experience at our institution, to treat these respective complications. While gastroparesis and orthostatic hypotension remain challenging post-operative conditions, the establishment of institutional protocols and step-up treatment algorithms can help define more effective therapies.

To determine the effectiveness of intrapyloric botulinum toxin injection (IPBI) for treatment of feeding disorders and associated gastrointestinal symptoms in very young children.

A single-center retrospective study of patients 2 months to 5 years old who received IPBI at Boston Children's Hospital from May 2007 to June 2019 was performed. Charts were reviewed for demographic data, comorbidities, symptoms leading to IPBI, oral and tube feeding data, symptom improvement after IPBI, and need for repeat injections. The primary outcome was symptom improvement at the first gastroenterology clinic visit following IPBI. Secondary outcomes included improvement in oral feeding, decreases in tube feeding, and need for repeat injections. The χ² or Fisher exact tests and multivariate logistic regression were used to identify factors associated with symptomatic improvement.

A total of 85 patients who received 118 injections were included in the final analysis; 57 patients (67%) had partial or complete improvement in symptoms after IPBI. Among the 55 patients with enteral tubes, there was an improvement in feeding, with more patients receiving at least some oral feeds after IPBI compared with before (26/55 vs 15/55; P = .004) and fewer patients receiving postpyloric feeds after IPBI compared with before (12/55 vs 21/55; P = .01). Twenty-six patients (31%) received repeat IPBI within 1 year, with only 6 patients receiving IPBI more than twice.

IPBI is safe and effective in young children. Children with enteral tubes show improvement in oral feeding and reduction in need for postpyloric feeding after IPBI.

Gastroparesis is a symptomatic chronic disorder of the stomach characterized by delayed gastric emptying in the absence of mechanical obstruction. Several endoscopic treatment modalities have been described that aim to improve gastric emptying and/or symptoms associated with gastroparesis refractory to dietary and pharmacologic management.

In this report we review devices and techniques for endoscopic treatment of gastroparesis, the evidence regarding their efficacy and safety, and the financial considerations for their use.

Endoscopic modalities for treatment of gastroparesis can be broadly categorized into pyloric, nonpyloric, and nutritional therapies. Pyloric therapies such as botulinum toxin injection, stent placement, pyloroplasty, and pyloromyotomy specifically focus on pylorospasm as a therapeutic target. These interventions aim to reduce the pressure gradient across the pyloric sphincter, with a resultant improvement in gastric emptying. Nonpyloric therapies, such as venting gastrostomy and gastric electrical stimulation, are intended to improve symptoms. Nutritional therapies, such as feeding tube placement, aim to provide nutritional support.

Several endoscopic interventions have shown utility in improving the quality of life and symptoms of select patients with refractory gastroparesis. Methods to identify which patients are best suited for a specific treatment are not well established. Endoscopic pyloromyotomy is a relatively recent development that may prove to be the preferred pyloric-directed intervention, although additional and longer-term outcomes are needed.

Gastroparesis is a complex chronic debilitating condition of gastric motility resulting in the delayed gastric emptying and multiple severe symptoms, which may lead to malnutrition and dehydration. Initial management of patients with gastroparesis focuses on the diet, lifestyle modification and medical therapy. Various endoscopic and surgical interventions are reserved for refractory cases of gastroparesis, not responding to conservative therapy. Pyloric interventions, enteral access tubes, gastric electrical stimulator and gastrectomy have been described in the care of patients with gastroparesis. In this article, the authors review current management, indications, and contraindications to these procedures.

The functional luminal imaging probe (FLIP) can measure tissue distensibility and geometric changes through volumetric distention. The esophagogastric junction has been well studied using EndoFLIP, studies on pylorus are lacking. We aim to study biomechanical properties of pylorus using EndoFLIP to create normative data.

We performed a prospective study of 20 healthy volunteers (ages, 18-54 years; 10 men) who underwent pylorus evaluation using 12- cm FLIP placed across the pyloric sphincter. FLIP data were analyzed using FLIP planimetry plots at baseline and after administration of hyoscine butyl bromide injection.

The median pylorus distensibility index (P-DI) was 8.37 mm²/mmHg (interquartile range, 4.22-13.04 mm²/mmHg) at 40 mL balloon volume. The 90th percentile at 40 mL balloon for P-DI was 14.89 mm²/mmHg, for cross-sectional area was 244.20 mm²/mmHg, and diameter and pressure were 17.58 mm and 48.84 mmHg, respectively. There was significant increase in P-DI after administration of hyoscine butyl bromide injection (P < 0.05).

The normative values can be used as reference values for pyloric distensibility. This reference can be used in studies of related to pyloric diseases such as gastroparesis.

Gastroparesis is characterized by delayed gastric emptying, with symptoms such as nausea, vomiting and abdominal pain, in the absence of mechanical obstruction. In most cases, it is idiopathic although diabetes mellitus is another leading cause. The physiology of gastric emptying is a complex process which is influenced by various inputs including the central nervous system, enteric nervous system and gut hormones. Developments in our understanding of gastroparesis have now demonstrated dysfunction in these systems, thus disrupting normal gastric emptying. Once mechanical obstruction is excluded, gastric scintigraphy remains the gold standard for diagnosis although wireless motility capsule and breath testing are alternative methods for diagnosis. Treatment for gastroparesis is challenging, and widely available therapies are often limited either by their poor evidence for efficacy or concerns over their long-term safety profile. Novel prokinetic agents have shown initial promise in clinical trials, and new endoscopic techniques such as gastric per-oral endoscopic myotomy are emerging. These new treatment modalities may provide an option in refractory gastroparesis with the adage of reduced morbidity compared to surgical treatments.

Despite increasing knowledge regarding gastroparesis (GP) in adults, little is known regarding the incidence, prevalence, and natural history of childhood GP. Exacerbating the knowledge gap in pediatric GP is both the lack of normative data for gastric emptying scintigraphy in children and lack of GP-specific pediatric reported outcome measures.

The aim of this article was to review the available literature on pediatric GP and identify similarities and differences with studies in adults. We performed a comprehensive search in MEDLINE and Google Scholar from inception to April 2019 for articles published in English using the following combination of keywords: gastroparesis, pediatric gastroparesis, outcomes, metoclopramide, erythromycin, domperidone, cisapride, and gastric neurostimulator. The limited available pediatric data, often retrospective, suggest marked differences between adult and pediatric GP in several aspects including etiology, concomitant co-morbidities (eg, psychiatric disorders), clinical symptom presentation, diagnostic evaluation, response to therapies, and clinical outcome. Further research in pediatric GP is needed and holds the promise to further elucidate the mechanisms of this disorder in children and lead to pediatric-focused therapies.

Botulinum toxin (BT), one of the most powerful inhibitors that prevents the release of acetylcholine from nerve endings, represents an alternative therapeutic approach for "spastic" disorders of the gastrointestinal tract such as achalasia, gastroparesis, sphincter of Oddi dysfunction, chronic anal fissures, and pelvic floor dyssynergia.BT has proven to be safe and this allows it to be a valid alternative in patients at high risk of invasive procedures but long-term efficacy in many disorders has not been observed, primarily due to its relatively short duration of action. Administration of BT has a low rate of adverse reactions and complications. However, not all patients respond to BT therapy, and large randomized controlled trials are lacking for many conditions commonly treated with BT.The local injection of BT in some conditions becomes a useful tool to decide to switch to more invasive therapies. Since 1980, the toxin has rapidly transformed from lethal poison to a safe therapeutic agent, with a significant impact on the quality of life.

Recent studies have reported that pyloric distensibility was altered in 30% to 50% of patients with gastroparesis, and this was correlated with gastric emptying and symptom severity. The aim of this study was to assess whether pyloric distensibility measurement was predictive of symptomatic response after intrapyloric botulinum toxin (BT) injection.

Pyloric distensibility was measured using the EndoFLIP system (Crospon, Galway, Ireland) before intrapyloric BT injection. Altered pyloric distensibility was defined as distensibility below 10 mm²/mm Hg. Total symptomatic score (TSS), dyspeptic symptoms, Gastrointestinal Quality of Life Index (GIQLI), and gastric emptying were investigated prospectively before and 3 months after BT injection.

Nineteen of 35 patients had altered pyloric distensibility. In those patients, TSS decreased at 3 months from 13.5 to 10.5 (P < .01), whereas it remained unchanged in patients with normal pyloric distensibility (P = .7). Gastric fullness (from 3.5 to 2.5; P = .03) and bloating (from 3.0 to 2.0; P = .01) were the only symptoms that improved in patients with altered pyloric distensibility, whereas none of them was improved in patients with normal pyloric distensibility. GIQLI score increased from 59.5 to 76.5 in patients with altered pyloric distensibility (P = .02), whereas there was no statistical difference (P = .43) in patients with normal pyloric distensibility. In patients with altered pyloric distensibility, gastric emptying half time was 223 minutes before and 190 minutes 3 months after injection (P = .02), whereas it remained unchanged in patients with normal pyloric distensibility (P = .6).

Pyloric distensibility measurement before intrapyloric BT injection predicted symptomatic and quality of life response 3 months after injection in patients with gastroparesis.

This review covers the epidemiology, pathophysiology, clinical features, diagnosis, and management of diabetic gastroparesis, and more broadly diabetic gastroenteropathy, which encompasses all the gastrointestinal manifestations of diabetes mellitus. Up to 50% of patients with type 1 and type 2 DM and suboptimal glycemic control have delayed gastric emptying (GE), which can be documented with scintigraphy, 13C breath tests, or a wireless motility capsule; the remainder have normal or rapid GE. Many patients with delayed GE are asymptomatic; others have dyspepsia (i.e., mild to moderate indigestion, with or without a mild delay in GE) or gastroparesis, which is a syndrome characterized by moderate to severe upper gastrointestinal symptoms and delayed GE that suggest, but are not accompanied by, gastric outlet obstruction. Gastroparesis can markedly impair quality of life, and up to 50% of patients have significant anxiety and/or depression. Often the distinction between dyspepsia and gastroparesis is based on clinical judgement rather than established criteria. Hyperglycemia, autonomic neuropathy, and enteric neuromuscular inflammation and injury are implicated in the pathogenesis of delayed GE. Alternatively, there are limited data to suggest that delayed GE may affect glycemic control. The management of diabetic gastroparesis is guided by the severity of symptoms, the magnitude of delayed GE, and the nutritional status. Initial options include dietary modifications, supplemental oral nutrition, and antiemetic and prokinetic medications. Patients with more severe symptoms may require a venting gastrostomy or jejunostomy and/or gastric electrical stimulation. Promising newer therapeutic approaches include ghrelin receptor agonists and selective 5-hydroxytryptamine receptor agonists.

Refractory gastroparesis is among the most difficult therapeutic challenges in gastroenterology. Pyloric dysfunction has been described in a subset of patients with gastroparesis, prompting experimentation with botulinum toxin injections into the pylorus, which is relatively safe and has been successfully used in other gastrointestinal disorders. However, causality between pyloric dysfunction and symptoms of gastroparesis has never been demonstrated. Although several open-label studies showed initial promise, 2 randomized clinical trials failed to elicit a difference in clinical outcomes in botulinum toxin versus placebo. Based on current evidence, further use of botulinum toxin for gastroparesis is discouraged outside of a research trial.

Gastroparesis is a debilitating progressive disease that significantly impacts a patient's life with limited and challenging treatments available. Although the pathogenesis is multifactorial, pylorospasm is believed to have a major underlying role. Several therapeutic interventions directed to the pylorus have been developed over the last decade, including intra-pyloric injections of botulinum toxin, transpyloric stenting, and surgical pyloroplasty. All of these treatment options had limited and disappointing results. More recently, gastric peroral endoscopic myotomy (G-POEM) has been reported as a treatment for refractory gastroparesis. In this review article, we provide an overview on gastroparesis with a focus on the therapeutic interventions. In addition, we provide a literature summary and pool analysis of the clinical efficacy, scintigraphic efficacy, and safety profile of all studies that evaluated G-POEM in gastroparesis. Overall, seven studies have reported on the use of G-POEM in gastroparesis, and the pooled analysis of these studies showed a technical success of 100%, with clinical efficacy as assessed by the Gastroparesis Cardinal Symptoms Index of 81.5%, gastric emptying scintigraphy normalization in approximately 55.5% of the cases, perioperative complications in 7.6%, and intraoperative complications in 6.6%. This suggests that G-POEM is a new promising therapeutic intervention for the treatment of gastroparesis with durable effect and limited potential adverse events.

This review provides an update on the investigations and treatment options for gastroparesis.

A comprehensive literature search of Medline, PubMed, Embase and OVID was conducted which included all systematic reviews and research articles that focused on the diagnosis, investigations and management diabetic gastroparesis.

Dietary modifications and pharmacologic treatment with prokinetics to increase gastric motility form the mainstay of treatment. However, the use of prokinetics is limited by adverse effects and serious adverse effects, leaving metoclopramide as the only drug approved by the US Food and Drug Administration for the treatment of gastroparesis. Newer therapies, including motilin receptor agonists, ghrelin receptor agonists, and neurokinin receptor antagonists, are currently being investigated. Transpyloric stenting, gastric electrical stimulation, and gastric per-oral endoscopic myotomy provide mechanical options for intervention, and surgical interventions in severe intractable gastroparesis include laparoscopic pyloroplasty or gastrectomy.

Advances to better understand the pathophysiology and management of diabetic gastroparesis have been limited, especially with discordance between symptoms and severity of delay in gastric emptying. Established treatment options are limited; however, recent pharmacologic and surgical interventions show promise.

Gastric peroral endoscopic pyloromyotomy (G-POEM) was introduced for treating refractory gastroparesis.

To present a series of patients focussed on clinical mid-term efficacy and predictive outcomes factors.

This was a single centre study of 29 patients operated on between January 2014 and April 2016, with disturbed gastric emptying scintigraphy (GES) and/or elevated Gastroparesis Cardinal Symptoms Index (GCSI). The procedures were performed as previously described. The primary endpoint was the efficacy at 3 and 6 months, based on GCSI and symptoms. The secondary endpoints were GES evolution, procedure reproducibility and safety, and identification of predictive factors for success.

There were 10 men, 19 women (mean age 52.8±18). The technical success rate was 100% (average 47 minutes). There were two complications managed conservatively: one bleeding and one abscess. The median follow-up was 10±6.4 months. The clinical success rate was 79% at 3 months, 69% at 6 months, with a significant decrease in the mean GCSI compared to pre-operatively (3.3±0.9 vs 1±1.2 and 1.1±0.9 respectively). The GES (n=23) normalised in 70% of cases, with a significant improvement of the mean half emptying time and retention at 2 hours, and a discordance in 21% of the cases. In univariate analysis, diabetes and female gender were significantly associated with risk of failure, but not confirmed in multivariate analysis.

The mid-term efficacy of G-POEM reaches 70% at 6 months. The procedure remains reproducible and safe. Diabetes and female gender were predictive of failure.

Gastric neurostimulation (GNS) with Enterra^® therapy device (Medtronic, Minneapolis, MN) appears as the last resort for patients with refractory gastroparesis. Currently, the device has Humanitarian Use status by Food and Drug Administration, thereby requiring further investigation. We aim to describe its feasibility and clinical outcomes using robotic technique. From June 2014 to September 2016, 15 consecutive patients underwent robotic insertion of Enterra^® device. Patient demographics, comorbidities, and clinical outcomes including mortality, length of stay, readmission rates, reoperation and complications were retrospectively collected. Patients were also assessed based on a validated 14-point questionnaire regarding satisfaction with the operation, quality of life and symptomatic relief. Mean age was 41.6 years ± 13.8 and there were 11 females (73.3%). No mortality was reported. The annual hospital admissions were reduced after GNS (2.5 ± 4.1 vs. 3.6 ± 4.4, p = 0.004). The frequency of bloating (p = 0.029) and severity of emesis (p = 0.038), early satiety (p = 0.042) and bloating (p = 0.031) were reduced after GNS. The severity and frequency total scores were also improved after GNS (12.6 ± 1.4 vs. 18.1 ± 2.7, p = 0.008 and 12.9 ± 2.2 vs. 16.1 ± 1.1, p = 0.016, respectively). This is the first report describing the clinical experience with robotic insertion of GNS device. This approach is safe and feasible and seems to have similar long-term outcomes as laparoscopic technique. Potential advantages to robotic technique include enhanced dexterity and suturing of the device within gastric wall. Further experience with large prospective studies and randomized clinical trials may be warranted.

Gastroparesis is a common complication after splenectomy and azygoportal disconnection, remaining a chronic debilitating disorder with considerable treatment challenges. To minimize postoperative gastroparesis, we have developed a new modified laparoscopic pyloroplasty (LP) technique for use during laparoscopic splenectomy and azygoportal disconnection (LSD).

We retrospectively evaluated the outcomes of 31 cirrhotic patients with portal hypertensive bleeding and secondary hypersplenism who underwent synchronous LSD with modified LP (n = 14) or LSD without modified LP (n = 17) between January 2015 and August 2015. Perioperative variables were compared.

LSD with and without modified LP were successful in all patients. Operation time was significantly longer for LSD with modified LP than LSD without modified LP ( P = .001). However, the LSD with modified LP group had significantly reduced incidences of bloating 1 month postoperatively ( P < .05), nausea ( P < .05), and bloating ( P < .05) 3 months postoperatively, gastric retention 3 months postoperatively ( P < .0001), and prokinetic use at 1 month ( P = .009) and 3 months postoperatively ( P < .05) compared with the LSD without modified LP group. Gastric emptying scintigraphy showed that the mean time required to empty 50% of the ingested meal was significantly shorter in the LSD with modified LP group than in the LSD without modified LP group at 3 months postoperatively (74.3 ± 19.1 vs 261.7 ± 61.0 minutes, P < .0001).

Modified LP during LSD was feasible, effective, and safe, and significantly reduced short-term symptoms of postoperative gastroparesis.

Gastroparesis is a syndrome that can be difficult to treat effectively and likely represents the common clinical presentation of multiple underlying mechanisms. One of these presumed mechanisms involves pyloric dysfunction, tied perhaps to spasm or fibrosis, manifesting as functional gastric outlet obstruction. Various diagnostic modalities have been used to better characterize this hypothesized abnormality, including most recently antroduodenal manometry and impedance planimetry. A variety of therapeutic interventions specific to the pylorus have also been proposed in the last several years, including intrapyloric injections of botulinum toxin, transpyloric stenting, surgical pyloroplasty, and endoscopic pyloromyotomy. The clinical application of these maneuvers has been mostly empiric thus far, but efforts are ongoing to identify the subset of patients whose physiology best positions them to benefit from such therapy. Early results for many of these interventions have been promising and will serve as the basis for larger and more systematic research frameworks moving forward.

Gastroparesis is a chronic, debilitating condition. We report an experience conducting gastric per-oral endoscopic pyloromyotomy (G-POEM) with objectives to assess clinical efficacy, gastric emptying evolution, and procedural adverse events.

This was a clinical pilot series on 12 consecutive patients who underwent G-POEM for refractory gastroparesis in our tertiary center between February 2014 and August 2015. Patients included had severe disease as defined by elevated Gastroparesis Cardinal Symptoms Index (GCSI) score and delayed gastric emptying scintigraphy (GES). G-POEM was performed by mucosal incision upstream the pylorus followed by submucosal tunnel and antropyloromyotomy with subsequent access closure. Efficacy was assessed at 5 days, 1 month, and 3 months, based on GCSI score, and individualizing (Likert scale) the main symptoms (nausea, vomiting, abdominal pain, early satiety, and anorexia). GES was performed 2 months after the procedure.

G-POEM was successfully performed in all 12 patients, yielding a technical success rate of 100%. Significant improvements in GCSI were observed: 3.5 ± .8 versus .9 ± .9 (1 month) and 1.1 ± 1.5 (3 months), respectively (P < .001), as well as the severity of main symptoms at 3 months. Clinical efficacy was 85% (10/12). GES normalized in 75% of cases, with improvement of half emptying time (222 ± 90 minutes vs 133 ± 90 minutes; P = .03) and retention at 2 hours (76% ± 20% vs 44% ± 26%; P = .009). There were no adverse events related to the procedure.

We report a single-center study evaluating G-POEM for refractory gastroparesis, demonstrating its feasibility, reproducibility, and safety with promising clinical and scintigraphic efficacy.

This review of the pathophysiologic basis for gastroparesis and recent advances in the treatment of patients with gastroparesis shows that there are several novel approaches to advance treatment of gastroparesis including diet, novel prokinetics, interventions on the pylorus, and novel forms of gastric electrical stimulation. The field of gastroparesis is likely to advance with further studies, with help from a guidance document from the Food and Drug Administration on gastroparesis, and with recent approval of the stable isotope gastric emptying test to ensure eligibility of participants in multicenter trials. Clinical experience and a formal, randomized, controlled trial provide insights on optimizing dietary interventions in patients with gastroparesis. This review addresses the biologic rationale of these different treatments, based on known physiology and pathophysiology of gastric emptying. The novel medications include the motilin agonist, camicinal; 5-HT4 receptor agonists, such as velusetrag; and the ghrelin agonist, relamorelin. New approaches target pylorospasm by stent placement, endoscopic pyloric myotomy, or laparoscopic pyloroplasty. These approaches offer the opportunity to achieve more permanent reduction of resistance to flow at the pylorus over the intrapyloric injection of botulinum toxin, which typically has to be repeated every few months if it is efficacious. A novel device, deployed in porcine stomach, involved per-endoscopic electrical stimulation. These promising approaches require formal, randomized, controlled trials and deployment in patients. The presence of concomitant antral hypomotility may be a significant factor in the responsiveness to interventions at the pylorus.

Controlled trials of gastric electrical stimulation (GES) for gastroparesis reported no significant improvement in symptoms, while open label studies suggested substantial clinical benefits.

To determine if GES is effective in reducing symptoms in patients with gastroparesis.

We searched PubMed and Embase for articles published in English (1990-2014) using "gastroparesis" as a search term restricted to "clinical trial". We included studies describing repeated patient-based symptom ratings before and during standardized treatments of at least one week duration.

Five studies randomly allocated patients to periods with or without GES. Total symptom severity (TSS) scores did not differ between these periods (0.17 [95% confidence interval: -0.06 to 0.4]; P=0.15). However, sixteen open label studies of GES showed a significant TSS decrease (2.68 [2.04-3.32]; Q=39.0; P<0.001). Other treatment modalities similarly improved TSS by 1.97 [1.5-2.44] for medical therapy (MED), by 1.52 [0.9-2.15] for placebo arms (PLA), and by 2.32 [1.56-3.06] for botulinum toxin (BTx). There were significant differences in baseline TSS ratings among these studies (GES: 6.28 [6.28-7.42]; MED: 4.76 [4.09-5.42]; PLA: 4.59 [3.77-5.42]; BTx: 6.02 [5.3-6.74]; Q=35.1; P<0.001). Meta-regression analysis showed these baseline differences to significantly impact TSS ratings during treatment (Q=71.8; P<0.001).

Independent of the treatment modality, baseline symptom severity impacts treatment results in gastroparesis. Considering the skewed population with refractory symptoms, regression to the mean likely contributes to the substantial discrepancies between the reported results of controlled and open label GES studies, raising questions about the use of GES outside of defined clinical trials.

A growing body of literature supports the use of laparoscopic pyloroplasty as a minimally invasive treatment of refractory gastroparesis that has failed conservative measures and for benign gastric outlet obstruction. Endoscopic pyloric dilation, stent placement, and Botox have been described for similar indications, but often with transient or mixed results. Per-oral pyloromyotomy has recently been proposed as an endoscopic alternative to surgical pyloroplasty or pylormyotomy because it is less invasive by its nature and potentially more durable than current endoscopic treatments.