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.

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.

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.

Bariatric endoscopic antral myotomy: a pilot study assessing technical feasibility, physiologic changes, and preliminary efficacy.

BACKGROUND AND AIMS: Gastric balloons and endoscopic sleeve gastroplasty appear to work by delaying gastric emptying. We hypothesized that pylorus-sparing antral myotomy would inhibit the antral pump, inducing gastric retention and similarly resulting in weight loss. METHODS: In this single-center pilot study, we assessed bariatric endoscopic antral myotomy (BEAM) using submucosal tunneling. The primary outcomes were feasibility, safety, and efficacy at 6 and 12 months, whereas the secondary outcomes were changes in the gastric-emptying rate and gastroparesis cardinal symptom index (GCSI) score. RESULTS: Six subjects underwent successful BEAM. One required needle decompression, and another developed pulmonary embolism, treated without sequela. At 6 and 12 months, patients achieved 9.1% ± 8.9% and 12.2% ± 7.1% total weight loss (P < .0005). The gastric-emptying rate was delayed by 36.6% in those with ≥10% total weight loss. The GCSI score increased significantly at 12 months, particularly regarding early satiety. CONCLUSIONS: This pilot study suggests BEAM is feasible and appears to induce delayed gastric emptying that is associated with significant weight loss, without symptoms of gastroparesis.

Utility of gastrostomy tube placement at the time of pancreaticoduodenectomy.

PURPOSE: The aim of this study is to investigate the utility of gastrostomy tube (G-tube) placement in reducing delayed gastric emptying (DGE) among patients undergoing pancreaticoduodenectomy (PD). METHODS: We retrospectively reviewed consecutive patients undergoing PD from 2015 to 2020 at our institution. Thirty-day patient outcomes including DGE, length of stay (LOS), reoperation rates, and morbidity were analyzed in patients with or without G-tube placement. RESULTS: 128 patients with resectable pancreatic head cancer (54 females, median age 68.50 [59.00-74.00]) underwent PD (66 had G-tube placement and 62 did not). There was no significant difference in the incidence of DGE (n = 17 vs. n = 17, p = 0.612), and LOS between the groups. Postoperative ileus (p = 0.007) was significantly lower while atrial fibrillation (p = 0.037) was higher among the G-tube group. Gastrostomy-related complications (p = 0.001) developed in ten patients: skin-related complications (n = 6), tube dislodgement (n = 3) and clogging (n = 1). Nine patients required reoperation during index admission (n = 4 vs. n = 5, p = 1.000). There was no difference in 30-day readmissions (n = 7 vs. n = 5, p = 0.471) and no difference in 30 or 90-day mortality. CONCLUSION: Gastrostomy tube placement during index PD did not affect the incidence of DGE. However, patients experienced significant morbidities due to G-tube-related complications. Placement of gastrostomy tubes at the index PD offers no clinical benefits.

Anterior gastric wall anastomosis may lead to lower rate of delayed gastric emptying after minimally invasive Ivor Lewis esophagectomy: a retrospective cohort study.

INTRODUCTION: In minimally invasive esophagectomy, a circular stapled anastomosis is common, but no evidence exists investigating the role of the specific localization of the anastomosis. The aim of this study is to evaluate the impact of an esophagogastrostomy on the anterior or posterior wall of the gastric conduit on the postoperative outcomes. MATERIAL AND METHODS: All oncologic minimally invasive Ivor Lewis procedures, performed between 2017 and 2022, were included in this study. The cohort was divided in two groups: a) intrathoracic esophagogastrostomy on the anterior gastric wall of the conduit (ANT, n = 285, 65%) and b) on the posterior gastric wall (POST, n = 154, 35%). Clinicopathological parameters and short-term outcomes were compared between both groups by retrieving data from the prospective database. RESULTS: Overall, 439 patients were included, baseline characteristics were similar in both groups, there was a higher proportion of squamous cell carcinoma in ANT (22.8% vs. 16.2%, P = 0.043). A higher rate of robotic-assisted procedures was observed in ANT (71.2% vs. 49.4%). Anastomotic leakage rate was similar in both groups (ANT 10.4% vs. POST 9.8%, P = 0.851). Overall complication rate and Clavien-Dindo > 3 complication rates were higher in POST compared to ANT: 53.2% vs. 40% (P = 0.008) and 36.9% vs. 25.7% (P = 0.014), respectively. The rate of delayed gastric emptying (20.1% vs. 7.4%, P < 0.001) and nosocomial pneumonia (22.1% vs. 14.8%, P = 0.05) was significantly higher in POST. CONCLUSION: Patients undergoing minimally invasive Ivor Lewis esophagectomy with an intrathoracic circular stapled anastomosis may benefit from esophagogastrostomy on the anterior wall of the gastric conduit, in terms of lower rate of delayed gastric emptying.

Refractory Gastroparesis Following Duodenal Switch Treated With Laparoscopic Subtotal Gastrectomy With Roux-en-Y Reconstruction.

Gastroparesis following duodenal switch (DS) is a known but rare complication. Typically, patients are managed with prokinetic agents, with pyloromyotomy being the first-line surgical therapy. The literature is sparse regarding how to manage patients whose symptoms remain refractory to these first-line therapies. We present a patient who experienced gastroparesis following DS, who fell into this category. Her symptoms of prandial pain and regurgitation remained resistant to medical management and pyloromyotomy. She was successfully treated with subtotal gastrectomy with Roux-en-Y reconstruction with resolution of these symptoms. The literature suggests that bypassing or resecting the pylorus and removing overstretched aperistaltic gastric muscle could be the mechanism behind this treatment's effectiveness.

Reappraisal of surgical and survival outcomes of 500 consecutive cases of robotic pancreaticoduodenectomy.

BACKGROUND: The role of the robotic approach for pancreaticoduodenectomy has not been well established with robust data. This study aimed to reappraise feasibility and justification of robotic pancreaticoduodenectomy (RPD) over time. METHODS: A total of 500 patients undergoing RPD were enrolled and divided into early (first 250 patients) and late (last 250 patients) groups for a comparative study. RESULTS: The conversion rate was 8.8% overall and was significantly lower in the late group (5.6% vs. 12.0%; p = .012). The overall median intraoperative blood loss was 130 mL. Radicality of resection was similar between early and late groups. The overall surgical mortality after RPD was 1.3%. The overall surgical morbidity and major complication was 44.1% and 13.2%, respectively, and similar between early and late groups. Chyle leakage was the most common complication after RPD (25.0%), followed by postoperative pancreatic fistula (POPF). The POPF rate was 8.6% overall, with 5.9% in the early group and 11.0% in the late group, p = .051. The overall delayed gastric emptying rate was 3.5%. The late group had better survival outcomes than those of the early group after RPD for ampullary adenocarcinoma (p = .027) but not for pancreatic head adenocarcinoma. CONCLUSIONS: Reappraisal of this study has confirmed that RPD is not only technically feasible without increasing surgical risks but also oncologically justified without compromising survival outcomes for both pancreatic head and other periampullary cancers over time. Moreover, RPD is associated with the benefits of low surgical mortality, blood loss, and delayed gastric emptying.

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.

Surgical Treatment of Gastroparesis.

Gastroparesis and intestinal dysmotility are life-altering diagnoses with no cure. Lifestyle changes, pharmacological, and surgical interventions are combined in a multidisciplinary fashion to improve the quality of life in this patient population. Starting with lifestyle changes, adjustments are made to the types and amounts of food consumed, medical conditions are optimized, and the use of narcotic pain medications as well as smoking is discontinued. For many, these changes are not enough, and antiemetics and promotility agents are used to control symptoms. Finally, when these measures fail, patients turn to surgery, which can include surgical alterations to the stomach, implantation of a gastric stimulator, placement of drainage tubes, and possibly even the complete removal of different organs, including the stomach or gallbladder. In our clinic, patients not only see a surgeon but also a gastroenterologist, dietitian, and psychologist. We strongly believe in a multidisciplinary approach to this condition. The goal is to provide patients with hope and help them live fuller and happier lives. The study primarily addresses technical considerations and the surgical approach for patients diagnosed with gastroparesis. It outlines the entire process, starting from preparations before the surgery, encompassing the preoperative work-up, and detailing the steps involved in the surgical procedure. One of the key diagnostic challenges faced in treating gastroparesis patients is determining the underlying cause of the condition, as this information is critical for selecting the appropriate surgical intervention. Once the patient's condition has been categorized based on the cause, the medical team engages in a discussion with the patient regarding potential treatment options, which may include endoscopic procedures, minimally invasive techniques, or open surgery.

Gastric per-oral endoscopic myotomy versus pyloric injection of botulinum toxin for the treatment of gastroparesis: our institutional experience and a systematic review of the literature.

INTRODUCTION: Gastric Per-Oral Endoscopic Myotomy (GPOEM) has been developed as an effective treatment option for patients with medically refractory gastroparesis. Other endoscopic options, such as pyloric injection of botulinum toxin (Botox), is often performed with limited efficacy. The purpose of this study was to evaluate GPOEM for the treatment of gastroparesis and compare its efficacy to Botox injection results reported in the literature. METHODS: A retrospective review was conducted to identify all patients who underwent a GPOEM for the treatment of gastroparesis between September 2018 and June 2022. Changes in Gastric Emptying Scintigraphy (GES) studies and Gastroparesis Cardinal Symptom (GCSI) scores from the preoperative to postoperative period were analyzed. In addition, a systematic review was conducted to identify all publications reporting the outcomes of Botox injections for the treatment of gastroparesis. RESULTS: A total of 65 patients (51 female, 14 male) underwent a GPOEM during the study period. Twenty-eight patients (22 female, 6 male) had both preoperative and postoperative GES studies in addition to GCSI scores. The etiologies of gastroparesis were diabetic (n = 4), idiopathic (n = 18), and postsurgical (n = 6). Fifty percent of these patients had undergone previous failed interventions including Botox injections (n = 6), gastric stimulator placement (n = 2), and endoscopic pyloric dilation (n = 6). Outcomes showed a significant decrease in GES percentages (mean difference = - 23.5%, p < 0.001) and GCSI scores (mean difference = - 9.6, p = 0.02) postoperatively. In the systematic review for Botox, transient mean improvements in postoperative GES percentages and GCSI scores were reported at 10.1% and 4.0, respectively. CONCLUSION: GPOEM leads to significant improvement in GES percentages and GCSI scores postoperatively and is superior to Botox injection results reported in the literature.

Efficacy and safety of gastric per-oral endoscopic myotomy (GPOEM) in lung transplant patients with refractory gastroparesis: a systematic review and meta-analysis.

BACKGROUND: Post-lung transplant gastroparesis is a frequent debilitating complication of lung transplant recipients, as it can increase the risk for gastro-esophageal reflux disease and subsequent graft dysfunction. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of GPOEM in lung transplant patients with refractory gastroparesis. METHODS: The present systematic review and meta-analysis wer performed according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. We selected studies that analyzed the gastroparesis cardinal symptom index (GCSI) before and after the procedure to verify the efficacy of GPOEM. Random-effects model was used and the analysis was performed with STATA 17. RESULTS: Four observational studies (one conference abstract) with 104 patients were included in the meta-analysis. Prior treatments for gastroparesis included prokinetic agents and botulinum toxin in 78% (78/104) and 66.7% (66/99), respectively. Pooled estimate for clinical efficacy of GPOEM was 83% (95% CI 76%-90%). The pooled mean reduction in GCSI following the procedure was - 2.01 (- 2.35, - 1.65, p = 0.014). Three studies reported statistically significant improvement of gastro-esophageal retention or emptying in the post-GPOEM period. 30-day post-operative complications included minor or major bleeding (11.6%), severe reflux (1.2%), and pyloric stenosis (1.2%) requiring re-intervention. 90-day all-cause mortality was 2.6% with one patient dying from severe allograft rejection. CONCLUSION: Our study showed that GPOEM is an effective and safe strategy for lung transplant patients with refractory gastroparesis and should be considered as a therapeutic strategy in this population. Larger multicenter trials are needed in the future to further evaluate the effect of GPOEM on allograft function and rates of rejection.

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.

PYloroplasty versus No Intervention in GAstric REmnant REconstruction after Oesophagectomy: study protocol for the PYNI-GAREREO phase III randomized controlled trial.

BACKGROUND: After esophagectomy for esophageal and esophagogastric cancer, more than half of patients have lost > 10% of their body weight at 12 months. In most cases, the gastric remnant is used for reconstruction after esophagectomy. One of the most serious nutritional complications of this technique is delayed gastric emptying caused by gastric remnant mobilization and denervation of the vagus nerve. The aim of the PYloroplasty versus No Intervention in GAstric REmnant REconstruction after Oesophagectomy (PYNI-GAREREO) trial is to analyze the clinical outcome of modified Horsley pyloroplasty (mH-P) as a method of preventing delayed gastric emptying. METHODS: The PYNI-GAREREO trial is designed as an open randomized, single-center superiority trial. Patients will be randomly allocated to undergo gastric remnant reconstruction with mH-P (intervention group) or no intervention (control group) in parallel groups. All patients with esophageal cancer or esophagogastric cancer planning to undergo curative minimally invasive esophagectomy will be considered for inclusion. A total of 140 patients will be included in the study and randomized between the groups in a 1:1 ratio. The primary outcome is the body weight change at 6 months postoperatively, and the secondary outcomes are the nutritional status, postoperative complications, functional outcome, and quality of life until 1 year postoperatively. DISCUSSION: We hypothesize that mH-P after minimally invasive esophagectomy more effectively maintains patients' nutritional status than no pyloroplasty. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000045104. Registered on 25 August 2021. https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051346 .