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.

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.

Response to botulinum toxin may predict response to peroral pyloromyotomy in patients with gastroparesis.

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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

A Contemporary Review of Surgical Approach and Outcomes in Pediatric Hypertrophic Pyloric Stenosis.

INTRODUCTION: In order to define optimal resources and outcome standards for infant pyloromyotomy, we sought to perform a contemporary analysis of surgical approach (laparoscopic versus open) and outcomes. METHODS: The National Surgical Quality Improvement Project Pediatrics Participant Use File (NSQIP PUF) was queried from 2016 to 2020. Utilization of laparoscopy was trended over time. Complication rates and length of stay were compared by operative approach. RESULTS: 9752 pyloromyotomies were included in the analysis. The utilization of laparoscopy steadily increased over the study time period (66% to 79%) and was associated with a shorter operative time. On multivariate regression, the utilization of laparoscopy was associated with a lower risk of overall complications, length of stay, and superficial surgical site infections. Overall complication rates were lower than previously reported (2.02%). The most common complication was superficial infection (1.2%). CONCLUSIONS: In facilities reporting to pediatric National Quality Improvement Project, utilization of laparoscopy has steadily increased, and complication rates are lower than previously reported. Complication rates and length of stay were lower with the laparoscopic approach in this contemporary cohort. These results offer benchmarks for quality improvement initiatives. The laparoscopic approach should be standard in facilities performing this procedure.

Single-incision versus conventional laparoscopic pyloromyotomy for pediatric hypertrophic pyloric stenosis: a systematic review and meta-analysis.

PURPOSE: To assess the safety and efficacy of single-incision versus conventional laparoscopic pyloromyotomy in pediatrics, we conducted a systematic review and meta-analysis. METHODS: A literature search was conducted to identify studies that compared single-incision laparoscopic pyloromyotomy (SILP) and conventional laparoscopic pyloromyotomy (CLP) for infants with hypertrophic pyloric stenosis (HPS). Meta-analysis was used to pool and compare variables such as operative time, time to full feeding, length of hospital stay, mucosal perforation, inadequate pyloromyotomy, wound infection, incisional hernia and overall complications. RESULTS: Among the 490 infants with HPS in the seven studies, 205 received SILP and 285 received CLP. There was significant longer time to full feeding for SILP compared with CLP. However, pooling the results for SILP and CLP revealed no significant difference in operative time, length of hospital stay and postoperative complications. CONCLUSIONS: SILP is a safe, feasible and effective surgical procedure for infants with HPS when compared to CLP. SILP is equivalent to CLP in terms of operative time, length of hospital stay and postoperative complications. We conclude that LS should be considered an acceptable option for HPS.

Omission of intraoperative pyloric procedures in minimally invasive esophagectomy: assessing the impact on patients.

Pyloroplasty or pyloromyotomy is often undertaken during esophagectomy to aid gastric emptying postoperatively. Minimally invasive esophagectomy (MIE) frequently omits a pyloric procedure. The impact on perioperative outcomes and the need for subsequent interventions is unclear. This study assesses the requirements for endoscopic balloon dilation of the pylorus (EPD) following MIE. Patients undergoing MIE from 2016 to 2020 were reviewed. Patients undergoing open resection, or an intraoperative pyloric procedure were excluded. Demographic, clinical and pathological data were reviewed. Univariable and multivariable analysis were performed as appropriate. In total, 171 patients underwent MIE. There were no differences in age (median 65 vs. 65 years, P = 0.6), pathological stage (P = 0.10) or ASA status (P = 0.52) between those requiring and not requiring endoscopic pyloric dilation (EPD). Forty-three patients (25%) required EPD, with a total of 71 procedures. Twenty-seven patients (16%) had EPD on their index admission. Seventy-five patients (43%) had a postoperative complication. Higher ASA status was associated with increased requirement for EPD (odds ratio 10.8, P = 0.03). On multivariable analysis, there was no association between the need for a pyloric procedure and overall survival (P = 0.14). Eight patients (5%) required insertion of a feeding jejunostomy in the postoperative period, with no difference between those with or without EPD (P = 0.11). Two patients required subsequent surgical pyloromyotomy for delayed gastric emptying. Although pyloroplasty or pyloromyotomy can safely be excluded during MIE, a quarter of patients will require postoperative EPD procedures. The impact of excluding pyloric procedures on gastric emptying requires further study.

Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial.

OBJECTIVE: Endoscopic pyloromyotomy (G-POEM) is a minimally invasive treatment option with promising uncontrolled outcome results in patients with gastroparesis. DESIGN: In this prospective randomised trial, we compared G-POEM with a sham procedure in patients with severe gastroparesis. The primary outcome was the proportion of patients with treatment success (defined as a decrease in the Gastroparesis Cardinal Symptom Index (GCSI) by at least 50%) at 6 months. Patients randomised to the sham group with persistent symptoms were offered cross-over G-POEM. RESULTS: The enrolment was stopped after the interim analysis by the Data and Safety Monitoring Board prior to reaching the planned sample of 86 patients. A total of 41 patients (17 diabetic, 13 postsurgical, 11 idiopathic; 46% male) were randomised (21 G-POEM, 20-sham). Treatment success rate was 71% (95% CI 50 to 86) after G-POEM versus 22% (8-47) after sham (p=0.005). Treatment success in patients with diabetic, postsurgical and idiopathic gastroparesis was 89% (95% CI 56 to 98), 50% (18-82) and 67% (30-90) after G-POEM; the corresponding rates in the sham group were 17% (3-57), 29% (7-67) and 20% (3-67).Median gastric retention at 4 hours decreased from 22% (95% CI 17 to 31) to 12% (5-22) after G-POEM and did not change after sham: 26% (18-39) versus 24% (11-35). Twelve patients crossed over to G-POEM with 9 of them (75%) achieving treatment success. CONCLUSION: In severe gastroparesis, G-POEM is superior to a sham procedure for improving both symptoms and gastric emptying 6 months after the procedure. These results are not entirely conclusive in patients with idiopathic and postsurgical aetiologies. TRIAL REGISTRATION NUMBER: NCT03356067; ClinicalTrials.gov.

Gastric per-oral endoscopic myotomy (G-POEM) for the treatment of gastric sleeve stenosis: a feasibility and safety study.

BACKGROUND: Traditional endoscopic treatments have limited success in gastric sleeve stenosis (GSS). Gastric peroral endoscopic myotomy (G-POEM) could conceivably obliterate the twist/angulation that causes GSS through a tunneled stricturotomy. We report early outcomes of G-POEM for GSS treatment. METHODS: We retrospectively reviewed all patients with GSS treated with G-POEM at our center. The primary end point was clinical success, defined as symptom improvement with resumption of adequate oral intake, without requiring further intervention. RESULTS: 13 patients (mean age 43 ±â€Š10.9 years; 12 female) underwent G-POEM for predominantly helical (11/13, 85 %) GSS. Three (23 %) had concurrent sleeve leak and 10 (77 %) had prior GSS treatment. Two intraoperative complications occurred, with no deviation to the procedure; no major complications occurred. At median follow-up of 175 (interquartile range [IQR] 119-260) days, clinical success was achieved in 10 patients (77 %). Median Gastroparesis Cardinal Symptom Index score in responders decreased from 2.06 (IQR 1.5-2.8) to 0.39 (IQR 0.2-0.5). Three patients (23 %) required surgical revision. CONCLUSIONS: G-POEM was feasible and safe, and may provide an alternative option for those averse to undergoing surgical revision for treatment of GSS.

Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis-A Systematic Review and Meta-Analysis.

INTRODUCTION: Infantile hypertrophic pyloric stenosis is treated by either open pyloromyotomy (OP) or laparoscopic pyloromyotomy (LP). The aim of this meta-analysis was to compare the open versus laparoscopic technique. METHODS: A literature search was conducted from 1990 to February 2021 using the electronic databases MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. Primary outcomes were mucosal perforation and incomplete pyloromyotomy. Secondary outcomes consisted of length of hospital stay, time to full feeds, operating time, postoperative wound infection/abscess, incisional hernia, hematoma/seroma formation, and death. RESULTS: Seven randomized controlled trials including 720 patients (357 with OP and 363 with LP) were included. Mucosal perforation rate was not different between groups (relative risk [RR] LP versus OP 1.60 [0.49-5.26]). LP was associated with nonsignificant higher risk of incomplete pyloromyotomy (RR 7.37 [0.92-59.11]). There was no difference in neither postoperative wound infections after LP compared with OP (RR 0.59 [0.24-1.45]) nor in postoperative seroma/hematoma formation (RR 3.44 [0.39-30.43]) or occurrence of incisional hernias (RR 1.01 [0.11-9.53]). Length of hospital stay (-3.01 h for LP [-8.39 to 2.37 h]) and time to full feeds (-5.86 h for LP [-15.95 to 4.24 h]) were nonsignificantly shorter after LP. Operation time was almost identical between groups (+0.53 min for LP [-3.53 to 4.59 min]). CONCLUSIONS: On a meta-level, there is no precise effect estimate indicating that LP carries a higher risk for mucosal perforation or incomplete pyloromyotomies compared with the open equivalent. Because of very low certainty of evidence, we do not know about the effect of the laparoscopic approach on postoperative wound infections, postoperative hematoma or seroma formation, incisional hernia occurrence, length of postoperative stay, time to full feeds, or operating time.

Per-oral Endoscopic Myotomy: State of the Art.

For more than a decade, per-oral endoscopic myotomy (POEM) has been performed for the treatment of achalasia and other dysmotilities of the esophagus. POEM has become an accepted alternative to Heller myotomy, a salvation technique for patients not responding to Heller myotomy and the favorite intervention for diffuse esophageal spasm and jackhammer esophagus. POEM paved the way for endoscopic pyloromyotomy, Zenker's diverticulum myotomy, and submucosal tunneling with endoscopic resection. This review will cover the technique and the most current literature of this revolutionary third space technique.

Gastric Peroral Endoscopic Myotomy: A Specific Learning Curve.

INTRODUCTION: Gastric peroral endoscopic pyloromyotomy (G-POEM) is a novel option for patients with gastroparesis. It involves submucosal tunneling across the pylorus, followed by pyloromyotomy, and subsequent closure of the endoscopic tunnel. The aim of this study was to determine the learning curve for G-POEM. METHODS: Consecutive patients undergoing G-POEM by a single operator were included from a prospective registry over 2 years. Demographics, procedure info, postprocedure follow-up data, and adverse events were collected. Nonlinear regression and cumulative sum control chart analyses were conducted for the learning curve. Clinical outcomes were improvement in Gastroparesis Cardinal Symptom Index score and gastric emptying scintigraphy. RESULTS: Thirty-six patients were included (16.7% M, mean age 46 y). The majority had idiopathic gastroparesis (n=16, 44%), with the remaining having diabetes (n=5, 17%), postsurgical (n=10, 28%), or other (n=4, 11%). Technical success was achieved in 35 of 36 (97%). There was a significant reduction in the total Gastroparesis Cardinal Symptom Index score (2.09 units, P<0.00001) and a significant reduction in postoperative gastric emptying scintigraphy (82.44 mins, P<0.00001). Mean follow-up was 15 months (SD, 1.05). Median procedure time was 60.5 minutes (range, 35 to 136). Cumulative sum control chart shows 60-minute procedure was achieved at the 18th procedure. Procedure durations further reduced with consequent procedures with the last 3 being 45 minutes, thus demonstrating continued improvement with ongoing experience (nonlinear regression P<0.0001). CONCLUSION: Endoscopists experienced in G-POEM are expected to achieve a reduction in procedure time over successive cases, with efficiency reached at 60.5 minutes and a learning rate of 18 cases with continuing improvement.

Efficacy and safety of endoscopic pyloric balloon dilation in patients with refractory gastroparesis.

BACKGROUND AND AIMS: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Gastroparesis with concomitant gastrointestinal dysmotility is not a contraindication for per-oral pyloromyotomy (POP).

INTRODUCTION: Per-oral pyloromyotomy (POP or G-POEM) provides significant short-term improvements in symptoms and objective emptying for patients with medically refractory gastroparesis, but it is unclear if patients with gastroparesis and co-existing dysmotility (small bowel or colonic delay) also benefit. In this study, we used wireless motility capsule (WMC) data to measure outcomes in patients with isolated gastroparesis (GP) and gastroparesis with co-existing dysmotility (GP + Dys) who underwent POP. METHODS: We retrospectively analyzed patients who had POP and completed WMC data during their evaluation of intestinal dysmotility. WMC data were reviewed to identify patients who demonstrated isolated GP or GP + Dys. Each patient's pre-op and post-op Gastroparesis Cardinal Symptom Index (GCSI) and 4-h solid-phase scintigraphy gastric emptying studies (GES) scores were compared to evaluate improvement. RESULTS: Of the entire cohort (n = 73), 89% were female with a mean age of 47.0 ± 15.0 years old. Gastroparesis etiologies were divided among idiopathic (54.8%), diabetic (26%), postsurgical (8.2%), autoimmune (5.5%), and multifactorial (5.5%). Forty-one patients (56%) had GP and 32 patients (44%) had GP + Dys. GCSI improved after POP whether the patient had isolated GP (- 12.31, p < 0.001) or GP + Dys (- 9.58, p < 0.001); however, there was no significant difference in total GCSI improvement between the two groups. A subset of patients had postoperative GES available (n = 47). In the isolated GP and GP + Dys cohorts, 15/28 (54%) and 12/19 (63%) patients had normal post-op 4-h GES, respectively, but no statistical difference between the two groups. CONCLUSION: Patients with medically refractory gastroparesis with and without concomitant gastrointestinal dysmotility show short-term subjective and objective improvement after POP. Concomitant small bowel or colonic dysmotility should not deter physicians from offering POP in carefully selected patients with gastroparesis.

Quantification of Interstitial Cells of Cajal in the Gastric Muscle of Patients with Gastroparesis at Per-Oral Endoscopic Pyloromyotomy: A Novel Approach for Future Research in Pathogenesis of Gastroparesis.

BACKGROUND: The role of Interstitial Cells of Cajal (ICC) in the pathogenesis of gastroparesis has been suggested by previous studies due to their involvement in the transmission of neuronal signaling to the smooth muscles of the GI tract. However, studies have been limited by the inability to obtain a gastric muscle sample, since routine endoscopy can only biopsy the mucosa. We present a new technique of muscle biopsy during per-oral endoscopic pyloromyotomy (GPOEM), a novel endoscopic procedure for treatment of gastroparesis. PATIENTS AND METHODS: All enrolled patients had diagnosed gastroparesis and had biopsies of the muscular layer at the antrum/pylorus during POEM. All GPOEM procedures took place from August 2019 to December 2019. Various demographic, disease-related, and procedure-related data were collected from chart review. ICC in the biopsy specimen was examined and quantitated. RESULTS: Through this method, we readily expose the gastric muscle of 21 patients through dissection of a gastric submucosal tunnel during GPOEM and provide reliable muscle sample for ICC quantification. Average number of ICC were higher in clinical responders (88 ICC ± 63 vs. 39 ICC ± 24, p = 0.02), defined as those who experienced significant improvement in nausea and vomiting symptoms after GPOEM. CONCLUSIONS: This study provides a reliable novel biopsy method for safely biopsy gastric muscle for quantitating the number of gastric ICC in patients with gastroparesis. The number of ICC may be related to the outcome of GPOEM therapy. However, further studies with larger number of patients are needed to confirm the results.

Endoscopic pyloromyotomy in minimally invasive esophagectomy: a novel approach.

BACKGROUND: Pyloric drainage procedures, namely pyloromyotomy or pyloroplasty, have long been considered an integral aspect of esophagectomy. However, the requirement of pyloric drainage in the era of minimally invasive esophagectomy (MIE) has been brought into question. This is in part because of the technical challenges of performing the pyloric drainage laparoscopically, leading many surgical teams to explore other options or to abandon this procedure entirely. We have developed a novel, technically facile, endoscopic approach to pyloromyotomy, and sought to assess the efficacy of this new approach compared to the standard surgical pyloromyotomy. METHODS: Patients who underwent MIE for cancer from 01/2010 to 12/2019 were identified from a prospectively maintained institutional database and were divided into two groups according to the pyloric drainage procedure: endoscopic or surgical pyloric drainage. 30-day outcomes (complications, length of stay, readmissions) and pyloric drainage-related outcomes [conduit distension/width, nasogastric tube (NGT) duration and re-insertion, gastric stasis] were compared between groups. RESULTS: 94 patients were identified of these 52 patients underwent endoscopic PM and 42 patients underwent surgical PM. The groups were similar with respect to age, gender and comorbidities. There were more Ivor-Lewis esophagectomies in the endoscopic PM group than the surgical PM group [45 (86%), 15 (36%) p < 0.001]. There was no significant difference in the rate of complications and readmissions. Gastric stasis requiring NGT re-insertion was rare in the endoscopic PM group and did not differ significantly from the surgical PM group (1.9-4.7% p = 0.58). CONCLUSIONS: Endoscopic pyloromyotomy using a novel approach is a safe, quick and reproducible technique with comparable results to a surgical PM in the setting of MIE.

Efficacy and safety of gastric peroral endoscopic myotomy (G-POEM) for refractory gastroparesis: 3-year follow up results.

BACKGROUND/PURPOSE: Gastroparesis is a common but easily overlooked disease. Gastric peroral endoscopic myotomy (G-POEM) is one of the third-space endoscopy techniques to treat gastroparesis. In this study, we aimed to evaluate the efficacy and safety of G-POEM for patients with refractory gastroparesis. METHODS: Between December 2017 and 2020, we consecutively enrolled patients with gastroparesis who failed after the administration of several kinds of medication and repeated admission for nutritional support. All patients underwent gastric emptying scintigraphy and answered a questionnaire on Gastroparesis Cardinal Symptom Index (GCSI). Demographic data, endoscopic procedure, and post procedural outcome were analyzed. RESULTS: A total of 11 (9 women and 2 men) patients with refractory gastroparesis (nine with diabetes mellitus, one systemic lupus erythematosus, and one idiopathic) were enrolled. The mean (±standard deviation (SD)) procedure time was 61.82 (±18.99) min with technical and clinical success rates of 100% and 81.82%, respectively. A statistically significant improvement was observed in the clinical severity (mean GCSI score 36.00 vs. 14.73, p < 0.0001) and gastric emptying time (mean T1/2 341.92 vs. 65.92 min, p = 0.016) after G-POEM. Hospital stay was 7.18 (±4.49) days without mortality. Complications included 4 (36.36%) patients with self-limited postprocedural abdominal pain and 3 (27.27%) patients with intra-procedural pneumoperitoneum. During the mean follow-up period of 554.36 days, one (9.09%) patient had relapsed clinical symptoms after 6 months. CONCLUSION: G-POEM is an efficient and safe pylorus-directed endoscopic therapy for refractory gastroparesis with promising results.

Long-term Outcome of Gastric Per-Oral Endoscopic Pyloromyotomy in Treatment of Gastroparesis.

BACKGROUND & AIMS: Gastric per oral endoscopic pyloromyotomy (GPOEM) is a promising treatment for gastroparesis. There are few data on the long-term outcomes of this procedure. We investigated long-term outcomes of GPOEM treatment of patients with refractory gastroparesis. METHODS: We conducted a retrospective case-series study of all patients who underwent GPOEM for refractory gastroparesis at a single center (n = 97), from June 2015 through March 2019; 90 patients had more than 3 months follow-up data and were included in our final analysis. We collected data on gastroparesis cardinal symptom index (GCSI) scores (measurements of postprandial fullness or early satiety, nausea and vomiting, and bloating) and SF-36 questionnaire scores (measures quality of life). The primary outcome was clinical response to GPOEM, defined as a decrease of at least 1 point in the average total GCSI score with more than a 25% decrease in at least 2 subscales of cardinal symptoms. Recurrence was defined as a return to baseline GCSI or GCSI scores of 3 or more for at least 2 months after an initial complete response. The secondary outcome was the factors that predict GPOEM failure (no response or gastroparesis recurrence within 6 months). RESULTS: At initial follow-up (3 to 6 months after GPOEM), 73 patients (81.1%) had a clinical response and significant increases in SF-36 questionnaire scores (indicating increased quality of life) whereas 17 patients (18.9%) had no response. Six months after GPOEM, 7.1% had recurrence. At 12 months, 8.3% of patients remaining in the study had recurrence. At 24 months, 4.8% of patients remaining in the study had a recurrence. At 36 months, 14.3% of patients remaining in the study had recurrence. For patients who experienced an initial clinical response, the rate of loss of that response per year was 12.9%. In the univariate and multivariate regression analysis, a longer duration of gastroparesis reduced the odds of response to GPOEM (odds ratio [OR], 0.092; 95% CI, 1.04-1.3; P = .001). On multivariate logistic regression, patients with high BMIs had increased odds of GPOEM failure (OR, 1.097; 95% CI, 1.022-1.176; P = .010) and patients receiving psychiatric medications had a higher risk of GPOEM failure (OR, 1.33; 95% CI, 0.110-1.008; P = .052). CONCLUSIONS: In retrospective analysis of 90 patients who underwent GPOEM for refractory gastroparesis, 81.1% had a clinical response at initial follow-up of their procedure. 1 year after GPOEM, 69.1% of all patients had a clinical response and 85.2% of initial responders maintained a clinical response. Patients maintained a clinical response and improved quality of life for as long as 3 years after the procedure. High BMI and long duration gastroparesis were associated with failure of GPOEM.

One-year results of gastric peroral endoscopic myotomy for refractory gastroparesis: a French multicenter study.

BACKGROUND: Data on the long-term outcomes of gastric peroral endoscopic myotomy (G-POEM) for refractory gastroparesis are lacking. We report the results of a large multicenter long-term follow-up study of G-POEM for refractory gastroparesis. METHODS: This was a retrospective multicenter study of all G-POEM operations performed in seven expert French centers for refractory gastroparesis with at least 1 year of follow-up. The primary endpoint was the 1-year clinical success rate, defined as at least a 1-point improvement in the Gastroparesis Cardinal Symptom Index (GCSI). RESULTS: 76 patients were included (60.5 % women; age 56 years). The median symptom duration was 48 months. The median gastric retention at 4 hours (H4) before G-POEM was 45 % (interquartile range [IQR] 29 % - 67 %). The median GCSI before G-POEM was 3.6 (IQR 2.8 - 4.0). Clinical success was achieved in 65.8 % of the patients at 1 year, with a median rate of reduction in the GCSI score of 41 %. In logistic regression analysis, only a high preoperative GCSI satiety subscale score was predictive of clinical success (odds ratio [OR] 3.41, 95 % confidence interval [CI] 1.01 - 11.54; P = 0.048), while a high rate of gastric retention at H4 was significantly associated with clinical failure (OR 0.97, 95 %CI 0.95 - 1.00; P = 0.03). CONCLUSIONS: The results confirm the efficacy of G-POEM for the treatment of refractory gastroparesis, as evidenced by a 65.8 % clinical success rate at 1 year. Although G-POEM is promising, prospective sham-controlled trials are urgently needed to confirm its efficacy and identify the patient populations who will benefit most from this procedure.

A prospective multicentre study of per-oral endoscopic myotomy (POEM) for achalasia in Australia.

OBJECTIVE: To describe the clinical and procedural outcomes of per-oral endoscopic myotomy (POEM) for achalasia in Australia. DESIGN, SETTING: Prospective observational study in three Australian tertiary referral centres, 5 May 2014 - 27 October 2019 (66 months). PARTICIPANTS: Patients who had undergone POEM for achalasia. MAJOR OUTCOME MEASURES: Eckardt scores calculated prior to POEM and six months, one year, and two years after POEM. The primary outcome was clinical success, defined as an Eckardt score of 3 or less without a second intervention. RESULTS: 142 patients underwent POEM for achalasia; their mean age was 52 years (SD, 18 years), 83 were men (58%), and the median length of hospital stay two days (IQR, 1-3 days). Their mean Eckardt score before POEM was 8.0 (SD, 2.4) and 1.1 (SD, 1.6) six months after POEM; it did not change significantly between six months and two years after POEM (mean monthly increase, 0.014 points; 95% CI, -0.001 to 0.029). A total of 127 patients (89%) improved clinically after POEM. Intra-procedural capnoperitoneum was the only risk factor associated with treatment failure (adjusted hazard ratio, 2.85; 95% CI, 1.08-7.51). Previous treatments - botulinum toxin injection (25 patients, 18%), endoscopic balloon dilatation (69, 49%), and Heller myotomy (14, 10%) - did not affect POEM outcomes. Five patients (4%) experienced major adverse events, including pneumonia, oesophageal leak, empyema and melaena, that were managed during admission and without sequelae. CONCLUSIONS: POEM is an effective treatment for achalasia. Significant reductions in Eckardt scores achieved by six months are sustained at two years. POEM can be both a first line definitive therapy and a salvage therapy for patients not helped by other treatments.

Gastric per-oral endoscopic myotomy versus pyloromyotomy for gastroparesis: An international comparative study.

BACKGROUND AND AIM: Gastroparesis is a potentially debilitating gastric motility disorder with limited treatment options. Highest efficacy treatments include gastric per-oral endoscopic myotomy (GPOEM) and surgical pyloromyotomy. This study compares the efficacy and safety of GPOEM versus laparoscopic pyloromyotomy for refractory gastroparesis. METHODS: Patients who underwent GPOEM or laparoscopic pyloromyotomy for refractory gastroparesis from four centers across the USA and Latin America were included in a dedicated registry. Data collected included patient demographics, imaging, laboratory values, clinical success, gastroparesis cardinal symptom index, procedure time, pre-op and post-op gastric emptying times, adverse events, and hospital length of stay. RESULTS: A total of 102 patients were included (mean age 47; 32.4% male): GPOEM n = 39, surgical pyloromyotomy n = 63.Technical success was 100% in both groups. Clinical success was 92.3% in the GPOEM group and 82.5% in the surgery group (P = 0.164). The GPOEM group had a significantly higher post-op GSCI score reduction by 1.3 units (P < 0.00001), post-op retention reduction at 2 h by 18% (P < 0.00001), post-op retention reduction at 4 h by 25% (P < 0.00001) and a lower procedure time by 20 min (P < 0.00001) as compared with surgery. GPOEM also had a lower hospital length of stay by 2.8 days (P < 0.00001). Adverse events were significantly fewer in the GPOEM group (13%) compared with surgery group (33.3%; P = 0.021). Mean blood loss in the GPOEM group was only 3.6 mL compared with 866 mL in the surgery group. CONCLUSIONS: The GPOEM may be a less invasive, safer, and more efficacious procedural treatment for refractory gastroparesis as compared with surgical pyloromyotomy.