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.

[S156] Comparing outcomes of per-oral pyloromyotomy and robotic pyloroplasty for the treatment of gastroparesis.

BACKGROUND: Gastroparesis is characterized by delayed gastric emptying without a significant obstructive pathology and is estimated to effect more than 5 million adults in the United States. Therapies for this condition are divided into two categories: gastric electrical stimulation or pyloric therapies to facilitate gastric emptying. Pyloric procedures include pyloroplasty, a well-documented procedure, and per-oral endoscopic myotomy (POP), a relatively novel endoscopic procedure that disrupts the pyloric muscles endoscopically. There is a paucity of literature comparing the two procedures. The aim of this study is to compare the outcomes of these two techniques. METHODS: Under an IRB protocol, data were collected prospectively from September 2018 through April 2021 at our institution for patients undergoing POP (n = 63 patients) or robotic pyloroplasty (RP) (n = 48). Preoperative and postoperative data including sex, race, age, BMI, and Gastroparesis Cardinal Symptom Index (GCSI) score were analyzed using univariate and multivariate analysis. RESULTS: There was no significant difference in sex, age, and BMI for both cohorts, but patients with RP were more likely to have private insurance, pre-op reflux, and PPI (p < .05 for all). Patients who underwent POP had significantly shorter operative time compared to RP (median 27 min vs 90, p < 0.001). The average change between preoperative and postoperative GCSI scores was significantly decreased for both interventions (POP mean = 8.2, RP 16.8, p < 0.001 both). However, comparing both data, RP has significantly better improvement in postoperative GCSI score than POP in both univariate (p < 0.001) and multivariate analysis (p = 0.030). This was reflected in the individual symptoms with nausea (p < 0.001), ability to finish meal (p = 0.037), abdomen visibly larger (p = 0.037) and bloating (p = 0.022) all showing improvement in both groups, but with RP having a more significant decrease in the scoring of these symptoms than POP. There was no significant difference in the number of postoperative complications (POP 19% vs RP 13%, p = 0.440). CONCLUSION: Even though both interventions are significantly associated with improvement of symptoms in patients with gastroparesis, our data demonstrates that robotic pyloroplasty has a superior response in comparison to per-oral endoscopic myotomy for the management of these symptoms. Per-oral pyloromyotomy has a similar complication rate to robotic pyloroplasty with a shorter operative time.

Endoscopic findings do not predict per-oral pyloromyotomy (POP) response.

INTRODUCTION: Gastroparesis is a life-altering diagnosis caused by the stomach's inability to function in the absence of a mechanical obstruction. The primary causes are idiopathic, diabetic, and postoperative. Our first-line treatment for medical refractory gastroparesis is the endoscopic per-oral pyloromyotomy (POP) procedure. Predicting clinical response cost effectively remains elusive. METHODS: All patients who underwent a POP procedure at our institution by a single surgical endoscopist from January 1, 2019 to June 30, 2020 were retrospectively reviewed. All endoscopic data were prospectively collected. The patients were followed by a survey including the Gastroparesis Cardinal Symptom Index (GCSI) and other relevant postoperative measures. The primary endpoint was clinical response defined as ≥ 1.0 decrease in the GCSI from preoperative to the time of survey. Secondary outcome was normalization of the gastric emptying study (GES). RESULTS: Our patient population is 85% female and has an average age of 44.8 years. The diagnosis of gastroparesis is 71% iatrogenic, 19% postoperative, and 10% diabetic. On endoscopy, 30% had bile in the stomach and 65% had any degree of pylorospasm. The primary outcome measure of clinical response was 39% at an average of 697 ± 151 days post-POP, but 66% of patients attested to an improvement in their symptoms. Of 68 postoperative gastric emptying studies 50% normalized at an average of 145 ± 98 days. Following univariate and multivariate analyses of preoperative data and endoscopic findings, there were no significant predictors of clinical response. A preoperative GCSI ≥ 2.6 trends toward significance (OR 6.87, p = 0.058). CONCLUSION: Endoscopic findings at the time of POP do not correlate with clinical response. The GCSI model currently used to measure clinical response may not accurately capture the full clinical picture. The long-term durability of endoscopic myotomy to treat medical refractory gastroparesis needs to be studied further to improve patient selection.

Poor Gastric Emptying in Patients with Paraesophageal Hernias: Pyloroplasty, Per-Oral Pyloromyotomy, BoTox, or Wait and See?

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.

Medical and surgical management of gastroparesis: a systematic review.

BACKGROUND: Gastroparesis (GPS) is a rare disease with multiple etiologies that results in delayed gastric emptying. Diagnosis of GPS can be challenging due to its rather complex clinical presentation. Pharmacologic refractory cases require surgical interventions, all of which have yet to be standardized and characterized. OBJECTIVES: We present a review of the literature and provide an update of current therapies for patients with GPS. SETTING: Department of General Surgery, Academic Hospital, United States. METHODS: We conducted a comprehensive search in PubMed, Google Scholar, and Embase of English-written articles published in the last 38 years, with an advance title search of "gastroparesis management." Other keywords included: "surgical management" and "refractory gastroparesis." Further references were obtained through cross-reference. RESULTS: A total of 12,250 articles were selected after eliminating duplicates. Following thorough screening of selection criteria, 68 full-text articles were included for review. CONCLUSION: GPS is a challenging disease to manage. Nutritional support must remain the primary approach, followed by either medical or surgical treatment modalities if necessary. In patients with refractory gastroparesis, adjunctive therapies have been proposed as promising long-term options.

Gastric per-Oral Endoscopic Myotomy for Refractory Gastroparesis: A Meta-Analysis.

BACKGROUND: The emerging gastric per-oral endoscopic myotomy (G-POEM) is becoming an alternative treatment method for gastroparesis. This study aimed to evaluate the feasibility and safety of G-POEM for gastroparesis. METHODS: Relevant publications were identified through searching PubMed, EMBASE, Cochrane Library, and Web of Science before April 1, 2019. Studies presenting the clinical data of G-POEM for the treatment of gastroparesis were included. Data about effectiveness and safety were extracted, pooled, and analyzed. Forest plots were graphed based on random effects models. RESULTS: A total of 272 patients representing 8 studies were eligible for analysis. The pooled rates of GCSI at preprocedure, 1-3 months, 6 months, and 12 months, were 3.25 (95% CI, 2.75-3.75), 1.80 (95% CI, 1.10-2.49), 1.56 (95% CI, 0.45-2.68), and 1.10 (95% CI, 0.75-1.45), respectively. The pooled results of 4-h GES pre- and post-G-POEM were 41.89% (95% CI, 32.75-51.03%) and 16.48% (95% CI, 9.83-23.14%), respectively. Furthermore, the pooled clinical response rate was 84% (95% CI, 77-89%). The GES improvement rate and GES normal rate were also analyzed, and the results were 84% (95% CI, 77-90%) and 53% (95% CI, 39-66%), respectively. Finally, the pooled adverse events rate was 12% (95% CI, 6-19%). CONCLUSIONS: G-POEM was shown to be feasible and safe for the treatment of gastroparesis with various etiologies, which could be a potential first-line therapy for certain patients. Future studies are needed to investigate the appropriate patients for G-POEM to explore the "most beneficial" subgroup of patients.

Recent advances in third space or intramural endoscopy.

Third space endoscopy or intramural endoscopy is based on the principle that the deeper layers of the gastrointestinal tract can be accessed by tunneling in the submucosal space and maintaining the integrity of the overlying mucosa. The era of third space endoscopy started with peroral endoscopic myotomy (POEM) for treatment of achalasia and has expanded to treat various other gastrointestinal disorders. The technique is also currently used for treatment of refractory gastroparesis, Zenker's diverticulum (ZD), resection of subepithelial tumors and early cancers of the gastrointestinal tract and Hirschsprung's disease (HD). These procedures are rapidly emerging as minimally invasive alternatives to conventional surgery. They are safe and effective with excellent outcomes. This review focuses on the evolution and current applications of third space endoscopy in various gastrointestinal disorders. Key points: (1) Third space or intramural endoscopy initially started with the POEM procedure for treatment of achalasia; (2) Advancements in procedural techniques have expanded its application to treat other gastrointestinal disorders such as refractory gastroparesis, ZD, HD, resection of subepithelial tumors and early gastrointestinal cancers; (3) These procedures are highly effective with excellent outcomes and low complication rates; and (4) Third space endoscopic procedures are rapidly emerging as minimally invasive alternatives to conventional surgery.

Per oral pyloromyotomy utilizing a lesser curvature approach: how we do it.

BACKGROUND: The treatment of gastroparesis refractory to medical therapy has evolved to include purely endoscopic techniques. Per oral pyloromyotomy (POP) has evolved from traditional laparoscopic or open pyloroplasty to become a safe and effective minimally invasive option for patients with gastroparesis. As compared to laparoscopic pyloroplasty (LP), POP produces similar improvements in gastric emptying and symptom mitigation, while having shorter lengths of stay. There are slight variations in technique that vary by institution. Described here is a technique utilizing a lesser curve approach, with a mucosotomy closure using clips in an effort to maximize efficiency of the procedure. METHODS: Preoperative workup includes a scintigraphic gastric emptying study or a wireless motility capsule study, and the Gastroparesis Cardinal Symptom Index (GCSI). After an upper endoscopy, the procedure begins with injection into the submucosal space with methylene blue in saline on the lesser curve, 3-5 cm proximal to the pylorus. A 1.5 cm incision is then made with the ERBE hybrid knife. A submucosal tunnel is created past the distal end of the pylorus, and the muscle is hooked, and divided with the hybrid knife. The mucosotomy is closed with clips (Boston Scientific Resolution 360, Boston, MA) after the completion of the myotomy. Post-operatively, patients are discharged home after an overnight stay with a proton pump inhibitor, sucralfate, and a full liquid diet for 2 weeks. CONCLUSIONS: A lesser curve approach with mucosotomy closure using clips is a safe, effective, and efficient modality for performing POP. As more centers adopt POP as a tool for gastroparesis management, the lesser curve method limits the length of the submucosal tunnel needed, and allows for wide adoption of the technique.

Gastric Per Oral Pyloromyotomy for Post-Vagotomy-Induced Gastroparesis Following Esophagectomy.

BACKGROUND: Following the success of per-oral endoscopic myotomy (POEM) for achalasia, application of this minimally invasive skillset has broadened to other disease processes. Since 2013, gastric per-oral pyloromyotomy (GPOP) has become an increasingly accepted therapy for refractory gastroparesis. Although it does not treat the underlying etiology of the disease, pyloromyotomy has demonstrated measurable improvements in gastric emptying scintigraphy, nausea, and quality of life. Gastroparesis is a common complication of esophagectomy due to the inherent vagotomy that occurs during creation of the gastric conduit. Fifteen to 30% of post-esophagectomy patients develop gastroparesis with a large portion of them reporting symptoms refractory to medical therapy, botox injection, and endoscopic dilation. Therefore, GPOP may have the potential to offer symptomatic relief to a significant population of debilitated post-esophagectomy patients. MATERIALS AND METHODS: The procedure was recorded using standard operating room equipment. Materials utilized included high-definition single-channel gastroscope, therapeutic overtube, clear endoscopic cap, triangle tip (TT) knife, ERBE energy source, endoscopic clips, sclerotherapy needle, methylene blue with epinephrine, and CO2 insufflator. RESULTS: We present a video of GPOP for a 71-year-old male with post-vagotomy-induced gastroparesis after esophagectomy. His pre-operative course was significant for persistent nausea and vomiting, diet intolerance, 20 lb weight loss, and frequent hospitalizations for aspiration pneumonia. Post-operatively, the patient recovered well and was discharged home on post-operative day 1 on a liquid diet. At 3-week follow-up, his nausea, vomiting, and PO intolerance had improved. At 6-month follow-up, he had no recent admissions for aspiration pneumonia and his pylorus remained widely patent on EGD. CONCLUSIONS: GPOP status post-esophagectomy presented multiple challenges: difficulty maintaining field of view and insufflation, establishing tension and counter tension for the mucosotomy, and a limited working space. With care and patience, endoscopists trained to perform POEM may apply their skillset to help a large population of patients suffering with post-esophagectomy gastroparesis.

Enhanced recovery outcomes following per-oral pyloromyotomy (POP): a comparison of safety and cost with same-day discharge versus inpatient recovery.

BACKGROUND: While per-oral pyloromyotomy (POP) has shown promise as a novel endoscopic procedure to treat medically refractory gastroparesis, standardized care pathways are not well-defined. We aimed to compare the safety and cost of same-day discharge (SDD) after POP with inpatient stay overnight or longer. METHODS: All patients with SDD after POP between January 2016 and May 2018 were retrospectively identified from a prospectively maintained registry. Propensity scores considering gender, age, gastroparesis etiology, and American Society of Anesthesiologists (ASA) class were used to match a comparison group which stayed overnight or longer. Statistical tests included two-sample t tests for continuous variables, Fisher's exact test for categorical variables, and paired sample t tests for within-group comparisons with repeated measures. RESULTS: Fifty-four patients who underwent POP with SDD during the study period were propensity-matched with 54 patients with inpatient recovery. The SDD cohort was 85.2% female with a mean age of 44.8 years and median ASA class 3. The etiology of gastroparesis was idiopathic in 53.7% (n = 29), diabetic in 29.6% (n = 16), and post-surgical in 11.1% (n = 6). Operative time was shorter in the SDD cohort (25.4 vs. 31.3 min, p = 0.02). The mean post-procedure recovery time was 4 h in patients with SDD and 29.3 h in the inpatient cohort (p < 0.001). There was a trend towards less readmissions with SDD (7.4% vs. 18.5%, p = 0.08). There was no increased risk of complications with SDD (1.9% vs. 3.7%, p = 0.57). Compared to inpatient recovery, the average total cost for the procedure, recovery, and all subsequent care within 30 days was 26.0% less with SDD (p < 0.001). CONCLUSIONS: Following POP, patients can be safely discharged the same day with low risk of both complications and readmission. Total costs in the complete perioperative period are significantly less with SDD compared to inpatient recovery.

Per-Oral Pyloromyotomy (POP) for Medically Refractory Post-Surgical Gastroparesis.

BACKGROUND: Post-surgical gastroparesis (psGP) is putatively related to vagal denervation from either therapeutic transection or inadvertent injury. Here, we present a series of patients undergoing endoscopic per-oral pyloromyotomy (POP) as a treatment for medically refractory psGP. METHODS: Patients identified from a prospectively maintained database of patients undergoing POP procedures at our institution from January 2016 to January 2018 were included. Surgical history, symptom scores, and gastric emptying studies before and 3 months after POP were additionally recorded. RESULTS: During the study period, 177 POP procedures were performed, of which 38 (21.5%) were for psGP. The study cohort was 84.2% female with a mean body mass index of 27.6 kg/m2 and mean age of 55.2 years. Common comorbidities included hypertension (34.2%), depression (31.6%), and gastroesophageal reflux disease (28.9%). Hiatal/paraesophageal hernia repair (39.5%) or fundoplication (36.8%) preceded psGP diagnosis most often. The mean operative time was 30 ± 20 min. There were no intraoperative complications. Mean postoperative length of stay was 1.2 days. There were two readmissions within 30 days, one for melena and one for dehydration. The mean improvement in total Gastroparesis Symptom Index Score was 1.29 (p = 0.0002). The mean 4-h gastric retention improved from a pre-POP mean of 46.4 to 17.9% post-POP. Normal gastric emptying was noted in 50% of subjects with available follow-up imaging. CONCLUSION: POP is a safe and effective endoscopic therapy for patients with psGP. POP should be considered a reasonable first-line option for patients with medically refractory psGP and may allow stomach preservation.

Outcomes and Future Directions of Per-Oral Endoscopic Pyloromyotomy: A View from France.

Gastroparesis is a challenging functional gastroenterological disorder, the complex pathophysiology of which hampers development of therapeutic modalities. Per-oral pyloromyotomy (POP) is a promising endoscopic therapy with a short-term clinical success rate of greater than 80%. Interest in POP is increasing, particularly in France, a country in which there is considerable expertise in submucosal endoscopy and functional disorders. Long-term follow-up and pyloric function evaluation are needed to assess the efficacy of POP in gastroparetic patients.

Gastric per-oral endoscopic myotomy for refractory gastroparesis: a detailed description of the procedure, our experience, and review of the literature.

BACKGROUND AND AIMS: Gastric per-oral endoscopic myotomy (G-POEM) was introduced four years ago as an investigational procedure for refractory gastroparesis. The safety and efficacy were currently evaluated. With our recent studies on G-POEM, we share our experience and knowledge through the discussion of a detailed description of the procedure and review of the literature. To our knowledge, this is the first systemic review on this new therapeutic endoscopic procedure. METHODS: The indications and contraindications, various aspects of the procedure, and efficacy assessment are discussed based on our experience and current available data. RESULTS: Preoperative preparation, detailed description of the procedure, post-procedural care, and results in the literature are presented. The procedure is safe and effective. 70-80% of patients have significant improvement in overall symptoms and quality of life in short-term (6 months) follow-up, as assessed by Gastric Cardinal Symptom Index and Short Form 36. CONCLUSIONS: G-POEM is a feasible and effective procedure for refractory gastroparesis based on early and limited data. Well-designed prospective studies are expected to advance and evaluate this new procedure in the future.

How I Do It: Per-Oral Pyloromyotomy (POP).

INTRODUCTION: Several surgical treatments exist for treatment of gastroparesis, including gastric electrical stimulation, pyloroplasty, and gastrectomy. Division of the pylorus by means of endoscopy, Per-Oral Pyloromyotomy (POP), is a newer, endoluminal therapy that may offer a less invasive, interventional treatment option. METHODS: We describe and present a video of our step by step technique for POP using a lesser curvature approach. The following are technical steps to complete the POP procedure from the lesser curve approach. CONCLUSION: In our experience, these methods provide promising initial results with low operative risks, although long-term outcomes remain to be determined.