Outcome of gastric electrical stimulator with and without pyloromyotomy for refractory gastroparesis.

BACKGROUND: Surgical treatments of refractory gastroparesis include pyloromyotomy and gastric electrical stimulator (GES). It is unclear if patients may benefit from a combined approach with concomitant GES and pyloromyotomy. METHODS: Retrospective cohort analysis of all patients with refractory gastroparesis treated with GES implantation with and without concomitant pyloromyotomy at Cleveland Clinic Florida from January 2003 to January 2023. Primary endpoint was efficacy (clinical response duration and success rate) and secondary endpoints included safety (postoperative morbidity) and length of stay. Success rate was defined as the absence of one of the following reinterventions during follow-up: Roux-en-Y gastric bypass (RYGB), pyloromyotomy, GES removal. RESULTS: During a period of 20 years, 134 patients were treated with GES implantation. Three patients with history of previous surgical pyloromyotomy or RYGB were excluded from the analysis. Median follow-up was 31 months (IQR 10, 72). Forty patients (30.5%) had GES with pyloromyotomy, whereas 91 (69.5%) did not have pyloromyotomy. Most of the patients had idiopathic (n = 68, 51.9%) or diabetic (n = 58, 43.3%) gastroparesis. Except for preoperative use of opioids (47.5 vs 14.3%; p < 0.001), patient's characteristics were similar in both groups. There were no significant differences between the two groups in terms of overall postoperative complications (17.5% vs 14.3%; p = 0.610), major postoperative complications (0% vs 2.2%; p = 1), and length of stay (2(IQR 1, 2) vs 2(IQR 1, 3) days; p = 0.068). At 5 years, success rate was higher in patients with than without pyloromyotomy however not statistically significant (82% versus 62%, p = 0.066). Especially patients with diabetic gastroparesis seemed to benefit from pyloromyotomy during GES (100% versus 67%, p = 0.053). In an adjusted Cox regression, GES implantation without pyloromyotomy was associated with a 2.66 times higher risk of treatment failure compared to GES implantation with pyloromyotomy (HR 2.66, 95% CI 1.03-6.94, p = 0.044). CONCLUSION: Pyloromyotomy during GES implantation for gastroparesis seems to be associated with a longer clinical response with similar postoperative morbidity and length of hospital stay than GES without pyloromyotomy. Patient with diabetic gastroparesis might benefit from a combination of GES implantation and pyloromyotomy.

Intra-operative pyloric BOTOX injection versus pyloric surgery for prevention of delayed gastric emptying after esophagectomy.

BACKGROUND: Delayed gastric emptying (DGE) is a common complication after esophagectomy. BOTOX injections and pyloric surgeries (PS), including pyloroplasty (PP) and pyloromyotomy (PM), are performed intraoperatively as prophylaxis against DGE. This study compares the effects of pyloric BOTOX injection and PS for preventing DGE post-esophagectomy. METHODS: We retrospectively reviewed Moffitt's IRB-approved database of 1364 esophagectomies, identifying 475 patients receiving BOTOX or PS during esophageal resection. PS was further divided into PP and PM. Demographics, clinical characteristics, and postoperative outcomes were compared using Chi-Square, Fisher's exact test, Wilcoxon rank-sum, and ANOVA. Propensity-score matching was performed between BOTOX and PP cohorts. RESULTS: 238 patients received BOTOX, 108 received PP, and 129 received PM. Most BOTOX patients underwent fully minimally invasive robotic Ivor-Lewis esophagectomy (81.1% vs 1.7%) while most PS patients underwent hybrid open/Robotic Ivor-Lewis esophagectomy (95.7% vs 13.0%). Anastomotic leak (p = 0.57) and pneumonia (p = 0.75) were comparable between groups. However, PS experienced lower DGE rates (15.9% vs 9.3%; p = 0.04) while BOTOX patients had less postoperative weight loss (9.7 vs 11.45 kg; p = 0.02). After separating PP from PM, leak (p = 0.72) and pneumonia (p = 0.07) rates remained similar. However, PP patients had the lowest DGE incidence (1.9% vs 15.7% vs 15.9%; p = < 0.001) and the highest bile reflux rates (2.8% vs 0% vs 0.4%; p = 0.04). Between matched cohorts of 91 patients, PP had lower DGE rates (18.7% vs 1.1%; p = < 0.001) and less weight loss (9.8 vs 11.4 kg; p = < 0.001). Other complications were comparable (all p > 0.05). BOTOX was consistently associated with shorter LOS compared to PS (all p = < 0.001). CONCLUSION: PP demonstrates lower rates of DGE in unmatched and matched analyses. Compared to BOTOX, PS is linked to reduced DGE rates. While BOTOX is associated with more favorable LOS, this may be attributable to difference in operative approach. PP improves DGE rates after esophagectomy without improving other postoperative complications.

Initial experience and outcomes of per oral pyloromyotomy for the treatment of refractory gastroparesis.

BACKGROUND: Gastroparesis can be a debilitating disease process for which durable treatment options are lacking. While dietary changes and pharmacotherapy have some efficacy, symptoms frequently recur and some patients progress to needing supplemental enteral feeding access. Per oral pyloromyotomy (POP) has been shown to be a durable minimally invasive treatment option for refractory gastroparesis with a low side effect profile, and therefore has been performed at this institution for the past 6 years. METHODS: This was a retrospective case series of all patients who underwent a POP at a single institution over a 6-year period (2018-2023). Patient demographics, preoperative symptomatology and subsequent workup, postoperative complications, and symptom recurrence were collected and analyzed. RESULTS: There were 56 patients included in the study. There was a 1.8:1 female:male ratio. The average patient age was 56 years old (range 23-85). The average duration of symptoms was 1-3 years. Thirty-eight percent of patients had undergone previous endoscopic therapy for gastroparesis (pyloric botox injection or pyloric dilation) and 16% of patients underwent multiple endoscopic therapies. Twenty-nine percent of patients were on a medication for gastroparesis. Past surgery was the most common gastroparesis etiology for POP (50% of patients). Diabetes (23%) and idiopathic (19%) were the other most common gastroparesis etiologies for POP. Nausea was the most common symptom at first follow-up (30%) but these patients continued to improve with 14% of patients continuing to endorse nausea at 6 months. Twenty-seven percent of patients developed symptom recurrence. Forty percent of patients with symptom recurrence underwent a repeat endoscopic or surgical therapy. CONCLUSIONS: In this present study, POP leads to durable results in approximately 75% of patients with minimal complications. Furthermore, the majority of patients who do develop symptom recurrence do not require additional gastroparesis interventions.

Esophageal Per-Oral Endoscopic Myotomy (E-POEM): Future Directions and Perspectives.

PURPOSE OF REVIEW: POEM is a mature procedure endorsed by societal guidelines as a first line therapy for achalasia and spastic esophageal disorders. Nonetheless, several questions remain, including expanding indications for POEM, periprocedural evaluation and management, and the optimal POEM technique to enhance clinical success while mitigating risk for reflux. RECENT FINDINGS: There is uncertainty regarding several technical aspects of the POEM myotomy; though aggregating evidence supports the use of real-time impedance planimetry to guide the myotomy. While post-POEM reflux remains a concerning long term sequela, there is an increasing focus on the potential role of endoscopic anti-reflux interventions. Lastly, with the widespread adoption of POEM, we continue to witness ongoing efforts to standardize post-procedural care and training in this procedure. POEM is no longer a novel but rather established procedure. Yet, this technique has continued to evolve, with the aim of optimizing treatment success while reducing adverse events and risk for post-procedural reflux.

Endoscopic pyloromyotomy for treatment of gastroparesis: A new standard or still an experimental approach?

Gastroparesis (GP) can be a severe and debilitating disease. Its pathophysiology is complex and not completely understood. Two principal mechanisms are responsible for the development of symptoms - gastric hypomotility and pylorospasm. Pylorus targeted therapies aim to decrease presumably elevated pyloric tone - pylorospasm. There is a growing body of evidence about their role in the treatment algorithm of GP. G-POEM (endoscopic pyloromyotomy) is an extensively studied pylorus targeted therapy. Its efficacy ranges between 56 and 80% and the number of recurrences among those with treatment effect seems low. G-POEM is a safe procedure with very low frequency of severe adverse events. At present, G-POEM should not be considered as an experimental approach and may be offered to all patients with refractory and severe GP. Nevertheless, G-POEM is not a first line treatment. Conservative measures such as diet modification and pharmacotherapy should always be tried before G-POEM is considered. Further research must focus on better patient selection as at present there are no standardized criteria. Functional imaging such as impedance planimetry (EndoFlip) may hold promise in this regard.

POEM in the esophagus - How to deal with the post-POEM reflux.

Reflux after peroral endoscopic myotomy (POEM) is arguably one of the greatest concerns related to the procedure. The exact incidence is difficult to establish as reflux symptoms, esophagitis, and abnormal acid exposure correlate poorly, warranting thorough diagnostic investigation. The incidence is, however, higher than after Heller myotomy or pneumatic dilatation across all these three parameters. Although PPI are effective in the resolution of symptoms and healing of esophagitis, refractory patients exist. Esophageal hypersensitivity and acidic fermentation/esophageal stasis are most likely causes and could be diagnosed by manual analysis of pH metry tracings. Long-term complications like peptic stricture and Barrett's esophagus are rare and reported sporadically. Modifications of POEM procedure aiming to decrease post-POEM reflux led to no conclusive preferred technique. Modern investigations like endoluminal functional lumen imaging probe might help to personalize myotomy to the desired distensibility of the lower esophageal sphincter and decrease reflux.

Do antro-duodenal manometry parameters predict clinical response after gastric peroral endoscopic pyloromyotomy in refractory gastroparesis?

BACKGROUND: Gastric peroral endoscopic pyloromyotomy (G-POEM) is a promising therapeutic modality for refractory gastroparesis (GP). However, as characteristics of suitable patients for G-POEM remain unclear, antro-duodenal manometry (ADM) has been suggested to provide objective parameters for patient selection. The aim of the present study was to identify ADM parameters as predictors for treatment response after G-POEM in refractory GP. METHODS: Refractory GP patients who underwent a G-POEM between 2017 and 2022 were included. The following ADM parameters were mainly scored: antral hypomotility, pylorospasm, and the presence of neuropathic enteric patterns. Treatment response was defined as a GCSI-score decrease of ≥1 point 12 months after G-POEM. Explorative analyses were performed on potential predictors of response using logistic regression analysis. KEY RESULTS: Sixty patients (52 women, mean age 52 ± 14 years.) with refractory GP (33 idiopathic, 16 diabetic, 11 postsurgical) were included. Clinical response data were available for 52 patients. In 8 out of 60 patients, it was not feasible to advance the catheter beyond the pylorus. Abnormal ADM was found in 46/60 patients (77%). Antral hypomotility and pylorospasm were found in respectively 33% and 12% of patients. At least one neuropathic enteric dysmotility pattern was found in 58% of patients. No differences were found when comparing baseline ADM parameters between clinical response groups at 12 months follow-up. Following explorative analyses, no ADM parameters were identified to predict clinical response 12 months after G-POEM. CONCLUSIONS AND INFERENCES: No ADM parameters were identified as predictors of clinical response after G-POEM in refractory GP patients. Additionally, a high percentage of abnormal ADM tracings was found, in particular with relation to enteric dysmotility, while only a low percentage of patients showed antral hypomotility or pylorospasm.

Gastroesophageal reflux following per-oral endoscopic myotomy: Can we improve outcomes?

This editorial is an analysis the review article by Nabi et al recently published in this journal. Achalasia Cardia is a disease whose pathophysiology is still unclear. It is known that there is inflammation of unknown aetiology leading to loss of ganglion cells in the muscularis propria. The end result is lower oesophageal sphincter spasm, loss of receptive relaxation, decreased oesophageal peristalsis, all leading on to varying degrees of dysphagia. The treatment of this condition is palliative in nature, performed by myotomy of the lower oesophagus either surgically or endoscopically. Gastroesophageal reflux disease (GERD) has been associated with the myotomy performed, particularly with the Peroral Endoscopic Myotomy (POEM) procedure. Nabi et al have provided an excellent overview of the latest developments in predicting, preventing, evaluating, and managing GERD subsequent to POEM. Based on this theme, this review article explores the concept of using histology of the oesophageal muscle layer, to grade the disease and thereby help tailoring the length/type of myotomy performed during the POEM procedure. In the future, will a histology based algorithm available preoperatively, help modify the POEM procedure, thereby decreasing the incidence of GERD associated with POEM?

Nutritional aspects in patients with gastroparesis.

PURPOSE OF REVIEW: The purpose of this review was to highlight most recent updates on nutritional aspects in gastroparesis (GP) focusing on dietary recommendations, utilization of enteral and parenteral nutrition, endoscopic and surgical interventions. RECENT FINDINGS: Recent data addressed eating patterns, nutritional interventions, and clarifications on the role of endoscopic and surgical interventions underlying an impact on nutritional management of GP patients. They support the importance of gastroparesis-specific diet in addition to drug therapy, and confirm the benefits of a modified low-fat, low-fiber diet. Current guidelines suggest a new approach to GP management based on predominant symptoms. Gastric peroral endoscopic pyloromyotomy (G-POEM) and surgical gastric electrical stimulator (GES) placement may be considered in individuals with nausea and vomiting before the need for jejunostomy tube placement for enteral feeding or parenteral nutrition. SUMMARY: Current literature supports the importance of dietary interventions, focusing on low-fat and low-fiber diets, in addition to drug therapies. Severely fiber-restrictive diets may not be necessary. There is enhanced understanding when jejunal feeding should be incorporated for refractory cases with consideration of G-POEM or/and GES even before jejunal tube placement. This approach will require patient evaluation in specialized motility centers.

Comparison between umbilical and right upper transverse abdominal incisions for pyloromyotomy: a systematic review and meta-analysis.

The aim of this study was to compare the operative parameters and complication rates between the umbilical (UMB) and right upper quadrant (RUQ) skin incisions for Ramstedt's pyloromyotomy for the treatment of infantile hypertrophic pyloric stenosis (IHPS). PubMed, EMBASE, Web of Science and Scopus databases were systematically searched. The studies where any one of the main outcomes of interest, i.e., operative time, wound infection rate, mucosal perforation rate were reported were eligible for inclusion. The statistical analysis was performed using a random-effects model. The methodological quality of the studies was assessed utilizing the Newcastle-Ottawa Scale. Fifteen studies comprising 2964 infants were included. As compared to the UMB group, the RUQ group showed a significantly lower mean operative time (p = 0.0004), wound infection rate (p < 0.0001) and mucosal perforation rate (p = 0.02). Although UMB incision produces an almost undetectable scar, this approach results in significantly more complications. Therefore, the risks and benefits must be weighed and discussed with the caregivers in deciding the surgical approach in patients with IHPS. However, due to a poor methodological quality of nine out of fifteen studies, further studies need to be conducted for an optimal comparison between the two groups.

Effectiveness of two-dimensional shear-wave sonoelastography in the diagnosis and follow-up of infantile hypertrophic pyloric stenosis.

INTRODUCTION: We sought to determine the effectiveness and utility of two-dimensional shear-wave sonoelastography (2D-SW-SE) in the diagnosis and postoperative follow-up of infantile hypertrophic pyloric stenosis (IHPS). MATERIALS AND METHODS: Twenty-three infants were included in the study, 13 in the IHPS group and 10 in the control group (CG). Preoperative B-mode ultrasonography measurements (longitudinal length and single-wall thickness of the pylorus) and 2D-SW-SE measurements (pylorus tissue stiffness and shear-wave propagation speed) were compared between the groups. The infants with IHPS then underwent Ramstedt pyloromyotomy and were invited for follow-ups on the tenth day and the first, third, and sixth months postoperatively. Measurements taken at the follow-ups were compared with the preoperative values. RESULTS: No differences were found between the groups regarding age, gender, body weight, or week of birth. The pyloric lengths in the IHPS group were longer than in the CG (p < 0.001), and the single-wall thicknesses were thicker (p < 0.001). The pylorus in the IHPS group was four times stiffer than in the CG (27.4 kPa versus 7.66 kPa), and the shear-wave propagation speed in the tissue was higher (1.34 m/s versus 2.69 m/s; p < 0.001). Both values decreased over time in the IHPS group and were normal by the third postoperative month. CONCLUSIONS: 2D-SW-SE can be used as an assistive imaging tool alongside B-mode ultrasound for diagnosing IHPS. It can also be used to identify inadequate surgery by detecting whether the pyloric tissue has softened at follow-up.

The Utility of Prophylactic Antibiotics for Laparoscopic Pyloromyotomy.

INTRODUCTION: Laparoscopic pyloromyotomy (LP) for the treatment of infantile hypertrophic pyloric stenosis (IHPS) is a clean case with low expected rates of postoperative surgical site infection (SSI). Previous studies have shown a low risk of SSI following LP but also large variations in the utilization of prophylactic antibiotics. The goal of this study was to review the use of preoperative antibiotics for LP and to compare this with SSI incidence. METHODS: We performed a retrospective single-center analysis of patients undergoing LP for infantile hypertrophic pyloric stenosis at a large quaternary children's hospital from January 2017 to June 2020. Subjects were <4 mo old. Exclusion criteria were those lost to follow-up within 30 d postoperatively and those who required open conversion intraoperatively. Statistical analysis was performed using Fisher's exact test, two-tailed independent t-tests, and descriptive statistics. RESULTS: Two-hundred twenty-seven patients were included, mean population age was 5.7 wk, and 81.1% were male. Preoperative antibiotics were administered in 39% of patients. Only 1.3% (n = 3) of all patients developed an SSI within 30 d of their operation. Analysis between patients who received preoperative antibiotics and those who did not revealed no difference in age (5.72 wk versus 5.72 wk, t (225) = 0.38, P = 0.70), sex (41% of males versus 32% of females, P = 0.39), length of stay (t(225) = -0.94, P = 0.35), or postoperative SSI (1.1% versus 1.4%, P > 0.999). Large variability was noted in antibiotic utilization by surgeon. CONCLUSIONS: In patients undergoing LP, there was no difference in SSI rates whether or not patients received preoperative antibiotics and, there is large variation in utilization. Measures are needed to decrease usage of prophylactic antibiotics before LP.

Optimizing throughput of babies with infantile hypertrophic pyloric stenosis.

BACKGROUND: Definitive surgical care is often delayed in hypertrophic pyloric stenosis (HPS). Our aim is to evaluate the effect modifiable factors in preoperative HPS management have on efficiency of care. METHODS: A retrospective review of all patients undergoing pyloromyotomy for HPS at two US children's hospitals between 2008 and 2018 was performed. RESULTS: 406 patients were included in the study. The majority (310, 76 â€‹%) were adequately resuscitated and ready for surgery upon diagnosis in the ER. However, only 133 patients (43 â€‹%) had surgery on the day of admission. Patients diagnosed between 12pm and 6pm were more likely to have surgery the next day than those diagnosed before noon (67 â€‹% vs 33 â€‹%, p â€‹< â€‹.001), which correlated with a longer length of stay (32 vs 47 â€‹h, p â€‹< â€‹.001). CONCLUSION: The majority of patients presenting with HPS can safely undergo same day surgery. Delaying surgery due to an afternoon diagnosis is common, and leads to a modifiable increased total length of stay.

Role of gastric peroral endoscopic myotomy (GPOEM) in chronic gastroparesis management after pancreas transplantation.

Gastroparesis is a common complaint among patients with diabetes. Symptoms tend to improve following successful pancreas transplantation (PTx), but persist despite euglycemia in a subset of patients. We aimed to assess the benefit of gastric peroral endoscopic myotomy (G-POEM) in persistent gastroparesis following PTx. This was a single center retrospective review of all patients who underwent G-POEM for persistent gastroparesis following PTx. Patient demographics, pre and post procedure perception of symptom severity according to the patient assessment of upper gastrointestinal symptoms severity index (PAGI-SYM), gastroparesis cardinal symptom index (GCSI) score, and 36-item short form survey (SF36) score along with gastric emptying scintigraphy (GES) were analyzed. Seven PTx recipients underwent G-POEM for persistent gastroparesis symptoms. The majority were female. All reported nausea/vomiting, abdominal pain, bloating, and post prandial fullness prior to G-POEM. The post procedure survey scores improved in all patients although this was not significant. The improvement in gastric emptying on GES was statistically significant. G-POEM is a relatively new treatment option for gastroparesis. While it requires specialized proceduralist and training, we have documented improvement in the management of symptoms. With increasing experience, we anticipate more significant benefit in post PTx patients with persistent symptoms of gastroparesis undergoing G-POEM.

Gastric peroral endoscopic myotomy versus botulinum toxin injection for the treatment of refractory gastroparesis: results of a double-blind randomized controlled study.

INTRODUCTION: Gastric peroral endoscopic myotomy (G-POEM) is a promising technique for treating refractory gastroparesis. We present the first double-blind randomized study comparing the clinical efficacy of G-POEM versus pyloric botulinum toxin injection (BTI). METHODS: This randomized study, conducted in two expert centers, enrolled patients with refractory gastroparesis, medically managed for >6 months and confirmed by gastric emptying scintigraphy (GES), into two groups, G-POEM versus BTI, with follow-up of 1 year. The primary end point was the 3-month clinical efficacy, defined as a >1-point decrease in the mean Gastroparesis Cardinal Symptom Index (GCSI) score. Secondary end points were: 1-year efficacy, GES evolution, adverse events, and quality of life. RESULTS: 40 patients (22 women; mean age 48.1 [SD 17.4]), with mean symptom duration of 5.8 (SD 5.7) years, were randomized. Etiologies included idiopathic (n=18), diabetes (n=11), postoperative (n=6), and mixed (n=4). G-POEM showed a higher 3-month clinical success than BTI (65% vs. 40%, respectively; P=0.10), along with non-significantly higher 1-year clinical success (60% vs. 40%, respectively) on intention-to-treat analysis. The GCSI decreased in both groups at 3 months and 1 year. Only three minor adverse events occurred in the G-POEM group. The GES improvement rate was 72% in the G-POEM group versus 50% in the BTI group (non-significant). CONCLUSION: G-POEM seems to have a higher clinically relevant success rate than BTI, but this was not statistically demonstrated. This study confirms the interest in treatments targeting the pylorus, either mechanically or chemically, for managing refractory gastroparesis.

Subtotal pyloric obstruction by atypical hypertrophic pyloric muscle in a newborn.

This is a case of a neonate with suspected duodenal atresia on prenatal imaging. However, distal bowel gas was identified postnatally on regular X-rays with a possible pyloric obstructing mass visualised on ultasound. No contrast was visualised passing through the stomach on fluoroscopic studies. Operative evaluation revealed an atypical asymmetric hypertrophic pylorus with exophytic lesions of ectopic glandular tissue. Longitudinal open pyloromyotomy was performed which relieved the gastric obstruction resulting in symptomatic relief without any anatomy altering procedure required.

G-POEM for gastroparesis: past, present and future.

PURPOSE OF REVIEW: Gastroparesis is a chronic debilitating condition with rising incidence and healthcare burden. As abdominal surgeries, diabetes, viral infections and autoimmune diseases become more prevalent, gastroparesis will continue to upsurge. Conservative treatment options for gastroparesis are limited by their side effects and short-term efficacy. Gastric endoscopic pyloromyotomy (G-POEM) is a novel incisionless endosurgical technique with excellent long-term outcomes. This review is in time, as the demand for G-POEM will continue to escalate. RECENT FINDINGS: This review encompasses the conservative and nonconservative treatment options for gastroparesis. G-POEM is a nonconservative treatment option, and the aim of this review is to discuss the variations in technique of G-POEM, short-term and long-term clinical efficacy of G-POEM and adverse events associated with it. SUMMARY: G-POEM has high technical and clinical success with minimal adverse events. G-POEM outcomes are similar or superior when compared with other treatment options for refractory gastroparesis. G-POEM is being widely adopted and will become the preferred treatment choice in patients with refractory gastroparesis.