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.

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.

The First Application of Intraumbilical Longitudinal Incision to Pyloromyotomy for Hypertrophic Pyloric Stenosis.

OBJECTIVE: There are several approaches to pyloromyotomy for the treatment of hypertrophic pyloric stenosis including open transumbilical pyloromyotomy and laparoscopic pyloromyotomy. Beginning in 2012, we adopted intraumbilical longitudinal incision as a new transumbilical approach for pyloromyotomy. We describe details of the operative technique and results of this new approach. METHODS: We reviewed records of patients undergoing transumbilical pyloromyotomy from 2005 to 2018. Perioperative outcomes were compared between intraumbilical longitudinal incision and supraumbilical incision, the latter of which is the conventional incision for transumbilical pyloromyotomy. RESULTS: Twenty-four patients underwent pyloromyotomy with intraumbilical longitudinal incision (intraumbilical group) and 28 patients with supraumbilical incision (supraumbilical group). The median operative time was longer in the intraumbilical group (58.0 vs. 43.5 min, p = 0.002). However, the time to full feeding did not differ significantly between the two groups, and the median postoperative stay was shorter in the intraumbilical group (3 vs. 5.5 days, p = 0.003). There was no difference in the rate of complications (4.2% vs. 7.1%, p = 1.0). Scars after intraumbilical longitudinal incision were localized inside the umbilicus. CONCLUSION: Pyloromyotomy can be performed through intraumbilical longitudinal incision as safely as supraumbilical incision and intraumbilical longitudinal incision may improve cosmetic results. This approach can be an alternative technique for pyloromyotomy.

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.

Gastric electrical stimulation versus per-oral pyloromyotomy for the treatment of nausea and vomiting associated with gastroparesis: An observational study of two cohorts.

BACKGROUND: Both gastric electrical stimulation (GES) and gastric-peroral endoscopic myotomy (G-POEM) can be offered to patients with gastroparesis and predominant nausea and vomiting. The study's aim was to compare GES and G-POEM efficacy on nausea and vomiting scores in patients with gastroparesis. METHODS: Two multicenter cohorts of patients with medically refractory gastroparesis with predominant nausea and vomiting (defined as a score >2 on nausea and vomiting subscale that varied from 0 to 4) were treated either with GES (n = 34) or G-POEM (n = 30) and were followed for 24 months (M). Clinical response was defined as a decrease of ≥1 point in nausea and vomiting subscale without premature exclusion due to switch from one to the other technique before M24. Changes in symptomatic scales and quality of life were also monitored. KEY RESULTS: Patients from both groups were comparable although the mean score of nausea and vomiting subscale was higher in GES (3.0) compared to G-POEM group (2.6; p = 0.01). At M24, clinical response was achieved in 21/34 (61.7%) patients with GES and in 21/30 (70.0%; p = 0.60) patients with G-POEM. Mean scores of nausea and vomiting subscale decreased at M24 in both GES (from 3.0 to 1.6; p < 0.001) and G-POEM (from 2.6 to 1.2; p < 0.001) groups, although there was no difference between groups (difference adjusted from baseline: -0.28 [-0.77; 0.19]; p = 0.24). Likewise, symptomatic and quality of life scores improved at M24 in both groups, without difference according to treatment group. CONCLUSIONS AND INFERENCES: At M24, we did not observe significant difference in efficacy of GES and G-POEM in medically refractory gastroparesis with predominant nausea and vomiting.

Analysis of esthetic assessment scales in two surgical approaches for hypertrophic pyloric stenosis. / Evaluación de escalas de valoración estética en dos abordajes quirúrgicos para la estenosis hipertrófica de píloro.

INTRODUCTION: Hypertrophic pyloric stenosis (HPS) is a frequent pathology in neonates, with extramucosal pyloromyotomy being a healing surgery. It may be performed through a transverse subcostal incision (TSI) or a transumbilical incision (TUI). OBJECTIVE: To compare complications, operating times, hospital stay, and esthetic results between both techniques. MATERIALS AND METHODS: A retrospective, descriptive study of patients undergoing HPS surgery between January 2010 and January 2020 was carried out. Qualitative variables (sex and complications) were expressed as absolute frequency and percentage, whereas quantitative variables (age at surgery, operating time, hospital stay, and scar esthetic assessment scales: MVSS [Modified Vancouver Scar Scale] and P-SAS [Patient Scar Assessment Scale]) were expressed as median and interquartile range. RESULTS: 107 patients were analyzed: TSI (60.7%, n = 65) vs. TUI (39.3%, n = 42). Male patients: 89.2%, n = 58 vs. 83.3%, n = 35; age (days): 31 (24.5-39.5) vs. 34.5 (29.5-47.25); operating time (minutes): 41 (33.75-60) vs. 46 (38.5-60); and hospital stay (days): 2 (2-4) vs. 3 (2-3). Clavien-Dindo grade II complications were more frequent in the TUI Group (1.54%, n = 1 vs. 23.81%, n = 10; p <0.001), with most of them being wound infections. The opinion regarding the scar according to the MVSS scale was better in the TUI Group (1.5 [0-4] vs. 0 [0-2]; p = 0.022). No significant differences were found in the P-SAS scale (10 (6-18) vs. 6 (6-9); p = 0.060). CONCLUSIONS: TUI is preferred from an esthetic point of view, and even though surgical wound infections are more frequent, it is not associated with longer operating times, longer hospital stay, or severe complications.

INTRODUCCION: La estenosis hipertrófica de píloro (EHP) es una patología frecuente en neonatos donde la piloromiotomía extramucosa es una cirugía curativa. Puede realizarse a través de una incisión transversa subcostal (IT) o una incisión transumbilical (ITU). OBJETIVO: Comparar complicaciones, tiempo quirúrgico y de hospitalización y resultado estético entre ambas técnicas. MATERIAL Y METODOS: Estudio descriptivo retrospectivo en pacientes intervenidos de EHP entre enero 2010-2020. Variables cualitativas (sexo y complicaciones) expresadas mediante frecuencia absoluta y porcentaje; y cuantitativas (edad en cirugía, tiempo operatorio, días de hospitalización y escalas de estética de cicatrices: MVSS (Modified Vancouver Scar Scale) y P-SAS (Patient Scar Assessment Scale)) expresadas mediante mediana y rango intercuartílico. RESULTADOS: Se analizaron 107 pacientes: IT (60,7%, n = 65) vs. ITU (39,3%, n = 42): varones (89,2%, n = 58 vs. 83,3%, n = 35), días de vida (31 [24,5-39,5] vs. 34,5 [29,5-47,25]), tiempo quirúrgico (41 [33,75-60] vs. 46 [38,5-60] minutos) y días de hospitalización (2 [2-4] vs. 3 [2-3]). Las complicaciones Clavien-Dindo II fueron más frecuentes en el grupo ITU (1,54%, n = 1 vs. 23,81%, n = 10; p <0,001), siendo la mayoría infecciones de la herida. En el grupo ITU presentaban una mejor opinión sobre la cicatriz en la escala MVSS (1,5 [0-4] vs. 0 [0-2]; p = 0,022). La escala P-SAS no alcanzó diferencias significativas (10 [6-18] vs. 6 [6-9]; p = 0,060). CONCLUSIONES: La ITU es mejor aceptada a nivel estético y, aunque presenta más infecciones de herida quirúrgica, no precisa más tiempo quirúrgico o de ingreso, ni asocia complicaciones graves.

Targeting the pylorus in gastroparesis: From physiology to endoscopic pyloromyotomy.

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

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.

Gastric Peroral Endoscopic Pyloromyotomy for Infants With Congenital Hypertrophic Pyloric Stenosis.

INTRODUCTION: Congenital hypertrophic pyloric stenosis (CHPS), the most common infantile disease requiring surgical intervention, is routinely treated with open or laparoscopic pyloromyotomy. Recently, gastric peroral endoscopic pyloromyotomy (G-POEM) has been used for adult gastroparesis. We aimed to evaluate the efficacy and safety of G-POEM in treating infantile CHPS. METHODS: We reviewed data from 21 G-POEM-treated patients at 3 tertiary children's endoscopic centers in China between January 2019 and December 2020. Clinical characteristics, procedure-related parameters, perioperative management, and follow-up outcomes were summarized. RESULTS: G-POEM was performed successfully in all patients. The median operative duration was 49 (14-150) minutes. The submucosal tunnels were successfully established along the greater curvature of the stomach in 19 cases, and 2 cases were switched to the lesser curvature because of difficulty. No perioperative major adverse events occurred. Minor adverse events included inconsequential mucosal injury in 5 cases and unsatisfactory closure of the mucosal incision in 1 case. Upper gastrointestinal contrast radiography in all patients showed smooth passage of the contrast agent through the pylorus on postoperative day 3. The growth curves of the patients reached normal levels 3 months after the procedure. No recurrent clinical symptoms occurred in any patient during the median follow-up period of 25.5 (14-36) months. DISCUSSION: G-POEM is feasible, safe, and effective for infants with CHPS, with satisfactory clinical responses over a short-term follow-up. Further multicenter studies should be performed to compare the long-term outcomes of this minimally invasive technique with open or laparoscopic pyloromyotomy.

[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.

Safety and feasibility of same day discharge after per oral endoscopic pyloromyotomy in refractory gastroparesis: a pilot study.

BACKGROUND: Gastroparesis is a debilitating medical condition with limited treatment options. Gastric per-oral pyloromyotomy (G-POEM) has emerged as a promising treatment option with remarkable short-term clinical success shown in multiple studies. While the post-procedure protocol is not standardized across many centers, the majority of the centers observes these patients in the hospital after the procedure for monitoring. In this single-center prospective study, we evaluated the safety and feasibility of same day discharge after the G-POEM procedure. METHODS: All the patients with refractory gastroparesis undergoing G-POEM from October 2019 to March 2020 were enrolled. A total of 25 patients were enrolled in the procedure. Based on the pre-defined criteria, patients were either discharged on the same day after the procedure or admitted to the hospital for further observation. The patient and procedure-related data were extracted from the chart review. Univariate analysis was performed (chi-squared test) on categorical variables after organizing categorical variables as numeric counts or percentages. The student t test was performed on continuous variables after reporting as mean and standard deviation. For analysis with a smaller sample size, Fisher exact and Mann-Whitney tests were used. RESULTS: A total of 25 patients were enrolled. The technical success of G-POEM was 100% and clinical success was 80% (20/25) at 1-month follow-up. Of the 25 patients, 9 patients (36%) were discharged on the same day according to the procedure from the recovery unit. Of the remaining 16 patients who were admitted to the hospital post-procedure, 10 (40%) were admitted due to procedure-related causes while other admissions were either pre-planned or due to social reasons. The average Charlson comorbidity index was lower in the same day discharge group ( P   <  0.05). The number of patients requiring double myotomy was higher in the same day discharge group ( P  < 0.05). The overall complication rate of G-POEM in the study cohort was 12% (3/25) with all complications being mild without any severe adverse events. CONCLUSION: G-POEM is a safe and effective method of treatment for refractory GP with higher clinical success in short-term follow-up. The same day discharge after G-POEM is safe and feasible in >50% of patients with close periprocedural monitoring.

Endoscopic clips versus overstitch suturing system device for mucosotomy closure after peroral endoscopic pyloromyotomy (G-POEM): a prospective single-center study.

BACKGROUND AND AIMS: G-POEM is an emerging method for treatment of severe gastroparesis. Safe mucosal closure is necessary to avoid adverse events. The aim of this study was to compare the efficacy of two closure methods: clips and endoscopic suturing (ES) after G-POEM. METHODS: We performed a single center, prospective study. The closure method was assigned at the discretion of an endoscopist prior to the procedure. The main outcome was the proportion of subjects with successful closure. Unsuccessful closure was defined as a need for a rescue method, or a need for an additional intervention or incomplete closure-related adverse events. Secondary outcomes were the easiness of closure (VAS score 1 = very difficult, 10 = easy), closure time, and cost. RESULTS: A total of 40 patients [21 female; mean age, range 47.5; (20-74)] were included; 20 received ES and 20 clips [mean number of clips 6; range (4-19)]. All 20 patients with ES (100%, 95% CI 84-100%) and 18 patients with clips (89%, 95% CI 70-97%) had successful closure (p = 0.49). One patient needed a rescue method (KING closure) and the other patient an additional clipping on POD1. Closure with clips was quicker [mean time 9.8 (range 4-20) min vs. 14.1 (5-21) min; p = 0.007] and cheaper [mean cost 807 USD (± 402) vs. 2353 USD (± 145); p < 0.001]. Endoscopist assessed the easiness of ES and clips as comparable [mean VAS, range 7.5 (3-10) (ES) vs. 6.9 (3-10) (clips); p = 0.3]. CONCLUSIONS: Both ES and clips are effective methods for mucosal closure in patients undergoing G-POEM. However, centres using clips should have a rescue closure method available as clips may fail in some patients. Closure with ES is more costly than with clips.

Transumbilical single-site two incision laparoscopic pyloromyotomy for pediatric hypertrophic pyloric stenosis.

PURPOSE: A new novel technique for the treatment of pediatric hypertrophic pyloric stenosis (HPS), transumbilical single-site laparoscopic pyloromyotomy with a single instrument (TUSSLP), was introduced. TUSSLP was compared with the transabdominal three-site laparoscopic pyloromyotomy (TATSLP) procedure. METHODS: Patients with HPS who underwent TUSSLP and TATSLP between January 2016 and September 2020 were assigned to group A and group B, respectively. The descriptive variables, perioperative clinical characteristics and postoperative follow-up results were retrospectively analyzed and compared between the 2 groups. The primary outcome of this study was the rate of switching to conventional pyloromyotomy. RESULTS: Sixty-four patients were enrolled in this study. Of these patients, 29 (22 males, 7 females, 54.4 ± 22.6 days) who received TUSSLP were assigned to group A. The remaining 35 (28 males, 7 females, 54.5 ± 27.6 days) who received TATSLP were assigned to group B. The data of preoperative patient variables were comparable between the 2 groups (P > 0.05). The mean operative time (ORT) was 28.1 ± 5.6 min in group A, which was not significantly different from 25.8 ± 3.1 min in group B (P = 0.25). The other perioperative features were not significantly different between the 2 groups (P > 0.05). During follow-up (39.1 ± 14.7 m in group A and 35.4 ± 16.1 m in group B, P = 0.51), no significant difference was observed in the overall incidence of vomiting between the 2 groups (P = 0.26). CONCLUSIONS: TUSSLP is a feasible and reliable minimally invasive method for HPS. It has the advantages of an improved cosmetic appearance. The postoperative follow-up results of TUSSLP are comparable with those of TATSLP.

Controlled long term outcome of pyloromyotomy for pyloric stenosis: No long-term adverse effect.

PURPOSE: Pyloromyotomy for pyloric stenosis is one of the more common surgical procedures performed on infants. The long-term effects of the procedure are however unclear. The purpose of this study was to study the effects into adult life, compare them with controls and to see if there is a need for structured follow up of patients. METHODS: Of the 101 patients operated for pyloric stenosis between 1972 and 1974 at our tertiary referral center 91 could be traced. They were all invited to participate in the study and were sent validated questionnaires (PAGI-SYM, GIQLI) as well as a study-specific questionnaire examining the use of antacid drugs, incidence of gastroscopy and abdominal surgery. Sixty patients responded (66%, mean age 45 years, 46 male) and were included. Thereafter, 600 age and sex-matched controls were sent the same questionnaires. 132 responded (22%, 90 male) and were includes as controls. RESULTS: No significant differences could be found in any of the examined parameters when looking at the whole material or the male patients. Female patients had higher PAGI-SYM-scores for post prandial fullness (mean 1.11 vs 0.43, P = 0.035) and heartburn (mean 0.59 vs 0.14, P = 0.043) when compared to controls. CONCLUSIONS: The present study shows that most patients operated for pyloric stenosis during infancy experience no negative effects into adulthood. The finding in the female patient group is interesting but is unlikely to have any clinical implications. The results from this study strongly implicate that there is no need for follow up of patients into adulthood. LEVEL OF EVIDENCE: Level III.

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.

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.

Gastric peroral endoscopic myotomy in refractory gastroparesis: long-term outcomes and predictive score to improve patient selection.

BACKGROUND AND AIMS: Limited data exist concerning the long-term efficiency of gastric peroral endoscopic myotomy (G-POEM) as a treatment of refractory gastroparesis. This study evaluated the 3-year results of G-POEM in patients with refractory gastroparesis. METHODS: This was a prospective multicenter study of all G-POEM operations performed in 2 expert French centers for 46 patients with refractory gastroparesis with at least 3 years of follow-up. RESULTS: Clinical success was 65.2% at 36 months. There was significant improvement in symptom severity. Median Gastroparesis Cardinal Symptom Index decreased from 3.33 to 1.80 (P < .0001), with improvement in all subscales. We created a predictive score concerning G-POEM success (G-POEM predictive score) to which points were assigned as follows: nausea subscale <2: predictive of success, 1 point; satiety subscale >4: predictive of success, 1 point; bloating subscale >3.5: predictive of success, 1 point; percentage of gastric retention at 4 hours on scintigraphy >50%: 1 point. A threshold of 2 was identified by receiver operating characteristic curve analysis with an area under the curve of .825 that predicted clinical success with a sensitivity of 93.3% (95% confidence interval [CI], .77-.99), specificity of 56.3% (95% CI, .33-.77), positive predictive value of 80% (95% CI, .67-.93), negative predictive value of 81.8% (95% CI, .59-1.00), and accuracy of 80.4% (95% CI, .69-.92). Patients with a score ≥2 were significantly more likely to be responders at 3 years than were patients with a score <2 (80% and 18%, respectively; P = .0004). CONCLUSIONS: The clinical success of G-POEM for refractory gastroparesis was 65.2% at 36 months. Our predictive score offers an easy tool that needs to be confirmed in other studies.

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.