Gastric Peroral Endoscopic Pyloromyotomy Research Articles

Correction: Gastric peroral endoscopic pyloromyotomy versus gastric electrical stimulation in the treatment of refractory gastroparesis: a propensity score-matched analysis of long term outcomes.

Correction: Gastric peroral endoscopic pyloromyotomy versus gastric electrical stimulation in the treatment of refractory gastroparesis: a propensity score-matched analysis of long term outcomes.

Outcomes of Gastric Per-Oral Endoscopic Pyloromyotomy for Severe Gastroparesis in a Lung Transplant Patient Population

Gastroparesis is a common and potentially devastating complication of lung transplantation. Initial results of Gastric Per-oral Endoscopic Pyloromyotomy (G-POEM) for the treatment of gastroparesis are encouraging but it's use in lung transplant is unknown. Retrospective cohort analysis of consecutive patients treated with G-POEM for medically refractory gastroparesis secondary to lung transplantation. Clinical, demographic, procedural and post procedural data was collected. 11 patient underwent G-POEM procedure. Technical and clinical success was noted in all 11 patients. Statistically significant decreases in gastroparesis symptom scores (GCSI) were noted in all 11 patients. In patients that obtained repeat GES, 100% experienced improvements in 4 hr GES emptying. Normalization of GES (<10% retention at 4 hrs) was noted in 3/7 patients. No significant difference in FEV1 or FVC was noted post G-POEM. 1 patient experienced accidental mucosotomy and 1 patient delayed pyloric stricture. All adverse events were managed endoscopically. G-POEM is a safe and efficacious treatment for medical refractory gastroparesis secondary to lung transplantation.

Gastric peroral endoscopic pyloromyotomy versus gastric electrical stimulation in the treatment of refractory gastroparesis: a propensity score-matched analysis of long term outcomes.

BACKGROUND : Gastric peroral endoscopic pyloromyotomy (G-POEM) and gastric electrical stimulation (GES) have been reported as treatment options for refractory gastroparesis. In this study, we compared the long term clinical outcomes of G-POEM versus GES in the treatment of such patients. METHODS : We retrospectively evaluated 111 consecutive patients with refractory gastroparesis between January 2009 and August 2018. To overcome selection bias, we used propensity score matching (1:1) between G-POEM and GES treatment. The primary outcome was the duration of clinical response. RESULTS : After propensity score matching, 23 patients were included in each group. After a median follow-up of 27.7 months, G-POEM had a significantly better and longer clinical response than GES (hazard ratio [HR] for clinical recurrence 0.39, 95 % confidence interval [CI] 0.16 - 0.95; P = 0.04). The median duration of response was 25.4 months (95 %CI 8.7 - 42.0) in the GES group and was not reached in the G-POEM group. The Kaplan - Meier estimate of 24-month clinical response rate was 76.6 % with G-POEM vs. 53.7 % with GES. GES appeared to have little effect on idiopathic gastroparesis (HR for recurrence with G-POEM vs. GES 0.35, 95 %CI 0.13 - 0.95; P = 0.05). The incidence of adverse events was higher in the GES group (26.1 % vs. 4.3 %; P = 0.10). CONCLUSION : Among patients with refractory gastroparesis, clinical response was better and lasted longer with G-POEM than with GES. The positive outcomes with G-POEM are likely to derive from the superior clinical response in patients with idiopathic gastroparesis. Further studies are needed to confirm these findings.

Role of endoscopic functional luminal imaging probe in predicting the outcome of gastric peroral endoscopic pyloromyotomy (with video)

Endoluminal functional luminal imaging probe (EndoFLIP) is an imaging tool that measures the physiologic characteristics of GI sphincters. In this study, we used EndoFLIP to evaluate the association between the pyloric physiologic measurements and the clinical outcomes of gastric peroral endoscopic myotomy (G-POEM) in patients with refractory gastroparesis. Thirty-seven patients from 5 centers who underwent G-POEM for management of refractory gastroparesis and had EndoFLIP measurements were evaluated. Cross-sectional area (CSA), balloon pressure, and the distensibility index (DI) of the pylorus were evaluated by EndoFLIP at 40 mL and 50 mL balloon fills before and after G-POEM. One-year clinical success and change in gastric emptying study 3 months after the G-POEM procedure were compared with the EndoFLIP measurements. Clinical success was achieved in 26 (70%) patients. Post-G-POEM CSA and DI were significantly higher in the clinical success group with both 40-mL volume distension (CSA: 89.9 ± 64.8 vs 172.5 ± 71.9mm2, P=.003; DI: 5.8 ± 4.4 vs 8.8 ± 6.1mm2/mm Hg, P=.043) and 50-mL volume distention (CSA: 140.1 ± 89.9 vs 237.5 ± 80.3mm2, P=.003; DI: 5.6 ± 3.3 vs 9.9 ± 6.6mm2/mm Hg, P=.049). CSA using 40-mL volume distention with an area under the curve of 0.83 yielded a specificity of 91% and a sensitivity of 71% at a cutoff point of 154mm2. Post-G-POEM CSA of the pylorus is associated with clinical success and improvement in a gastric emptying scan after G-POEM. EndoFLIP measurements of the pylorus have the potential to be used as a tool to predict the clinical outcome of G-POEM.

Short-term outcomes of double versus single pyloromyotomy at peroral endoscopic pyloromyotomy in the treatment of gastroparesis (with video)

The prevalence of gastroparesis (Gp), a chronic debilitating disorder, and resulting hospitalizations are increasing. Gastric peroral endoscopic pyloromyotomy (POP or GPOEM) is a novel technique in the treatment of refractory Gp. Despite the initial promising results of GPOEM, one-third of patients do not exhibit any clinical response. Furthermore, loss of clinical response was reported in several studies. No response or loss of response after GPOEM may be related to inadequate myotomy. The aim of our study is to examine whether double pyloromyotomy at GPOEM is superior to single pyloromyotomy. A retrospective case-controlled study of patients who underwent GPOEM for refractory Gp at our tertiary care institution between June 2015 and March 2018 was performed. Because the follow-up time for the single myotomy group was much longer than that of the double myotomy group, we matched the length of follow-up for the single myotomy group to that of the double myotomy group. The outcomes were measured by the changes in the Gastroparesis Cardinal Symptom Index (GCSI) before and 3 to 6 months after the procedure. Adverse events and other procedural and clinical parameters were also compared. Ninety patients underwent GPOEM (55 single and 35 double pyloromyotomy). The mean age was 47 ± 14 years, and the mean duration of symptoms was 5.3 ± 4.4 years. The average GCSI score was 3.8 before the GPOEM, and the average GCSI score 6 months after procedure was 1.8. Thirty-seven of 55 (67%) patients who underwent single pyloromyotomy achieved clinical response compared with 30 of 35 (86%) patients who underwent double pyloromyotomy. There were no significant differences for procedure time, postoperative pain, or length of hospital stay between the 2 groups. There was no difference in adverse events in the 2 pyloromyotomy groups. Double pyloromyotomy is a safe and feasible technique during GPOEM. Clinical success was higher in patients undergoing double pyloromyotomy compared with single pyloromyotomy in this nonrandomized, short-term follow-up study. Long-term studies are needed to further confirm our results.

Proximal and Distal Gastric Retention Patterns in Gastroparesis and the Impact of Gastric Per-Oral Endoscopic Myotomy: A Retrospective Analysis Using Gastric Emptying Scintigraphy.

Gastroparesis is a debilitating disease of insufficient gastric emptying and visceral hypersensitivity characterized by nausea, vomiting, early satiety, and bloating. Gastric emptying scintigraphy (GES), in combination with typical symptoms and normal esophagogastroduodenoscopy findings, is used to diagnose the disease. Gastric per-oral endoscopic pyloromyotomy (G-POEM) has emerged as a novel technique for treating gastroparesis, with up to an 80% success rate. This procedure involves myotomy of the distal stomach. We hypothesize that responders to this therapy are characterized by more distal dysmotility than nonresponders, as defined by GES retention patterns. Methods: We used regional gastric emptying measurements from diagnostic GES to determine the proximal or distal predominance of disease for each patient. We then compared treatment response and symptoms in each patient to total gastric half-emptying time (T½), proximal gastric T½, and a ratio comparing the 2 values. Results: In total, 47 patients underwent G-POEM during the study period. A significant difference (P < 0.01) was found in proximal-to-total T½ ratio between responders and nonresponders. A significant difference between pre- and postprocedural proximal-to-total T½ ratios was identified for each patient. No correlations were identified between motility patterns and symptoms or in motility patterns among the different etiologies of the disease. Conclusion: Proximal-to-total T½ ratio may represent an important patient selection factor for G-POEM versus other treatment modalities going forward. Local retention patterns in GES may not inform the symptom profile in gastroparesis.

Tu2039 – Gastric Peroral Endoscopic Pyloromyotomy (G-POEM) for Refractory Gastroparesis: A Meta-Analysis with Predictors of Response Based on Subtypes and Procedure Characteristics

Tu2039 – Gastric Peroral Endoscopic Pyloromyotomy (G-POEM) for Refractory Gastroparesis: A Meta-Analysis with Predictors of Response Based on Subtypes and Procedure Characteristics

Association between duration or etiology of gastroparesis and clinical response after gastric per-oral endoscopic pyloromyotomy

Gastric per-oral endoscopic pyloromyotomy (GPOEM) is a novel procedure with promising potential for the treatment of gastroparesis but with limited data regarding predictors of clinical response. This study aims to evaluate the safety and efficacy of the procedure and explore the impact of duration and etiology (diabetic vs nondiabetic) of gastroparesis on clinical outcome as measured by the Gastroparesis Cardinal Symptom Index (GCSI). A single-center retrospective longitudinal study at a tertiary care hospital was performed over an 18-month period. Forty patients with refractory gastroparesis (25 nondiabetic and 15 diabetic patients) were included. GCSI significantly improved throughout the study period (F[2.176, 17.405]= 10.152, P= .001). The nausea/vomiting subscale showed sustained improvement through 18 months (F[2.213, 17.704]= 15.863, P< .00001). There was no significant improvement in bloating (F[2.099, 16.791]= 1.576, P= .236). Gastric scintigraphy retention was significantly reduced by 41.7% (t= -7.90; P< .00001). Multivariate linear regression modeling revealed a significant correlation between the duration of disease and a GCSI improvement at 12 months (P= .02), with a longer duration of disease associated with a poorer long-term response. The etiology of gastroparesis was not associated with clinical improvement (P= .16). Adverse events (7.5%) included 1 capnoperitoneum, 1 periprocedure chronic obstructive pulmonary disease exacerbation, and 1 mucosotomy closure site disruption. GPOEM appears to be a safe and effective minimally invasive therapy for refractory gastroparesis, especially for patients with predominant nausea/vomiting and shorter duration of disease, regardless of the etiology. We propose the clinical criteria for undergoing GPOEM should be a GCSI of at least 2.0 and a gastric retention of greater than 20%.

Does Gastric Retention Pattern Affect Outcome of Gastric Peroral Endoscopic Myotomy for Patients with Gastroparesis? A Preliminary Study

Introduction: Gastroparesis is a disease of impaired gastric motility characterized by nausea, vomiting, early satiety and bloating. Gastric emptying scintigraphy (GES) is primarily used for diagnosis. Gastric per-oral endoscopic pyloromyotomy (G-POEM or POP) has emerged as a novel technique for treating gastroparesis with up to an 80% success rate. As this procedure involves pyloromyotomy, we hypothesize that responders to this therapy are characterized by a more distal retention pattern on GES when compared with non-responders. Methods: This is a retrospective study with IRB approval. We used standardized 4-hour GES as per the SNMMI procedure guideline to quantify proximal and distal retention using the incisura as an anatomical landmark, separating two regions (Figures 1 and 2). Baseline and post-procedure symptom severity were measured using the Gastroparesis Cardinal Symptoms Index (GCSI). Responders were defined by a reduction of at least 1 point in total GCSI and a 25% reduction in at least 2 of the 3 symptom subscales. We compare treatment response and symptom profile in each patient to total gastric half-emptying time (T1/2), proximal gastric T1/2 and a ratio comparing the proximal to total gastric T1/2, which we call retention index (RI). RI serves as a proxy for retention location, with a larger value representing more proximal disease.749_A Figure 1. Proximal stomach selection on gastric emptying scintigraphy in anterior (left) and posterior (right) projections.749_B Figure 2. Distal stomach selection on gastric emptying scintigraphy in anterior (left) and posterior (right) projections.Results: 47 patients underwent G-POEM during the study period. A significant difference (P<0.01) was found in pre-procedure RI between responders and non-responders (Figure 3). A decrease in RI was identified for each patient following the procedure. No significant differences were identified in baseline total or proximal T1/2 between the two groups. No correlations were found between motility patterns and predominant symptoms.749_C Figure 3. Pre-procedure Retention Index vs. Total GCSI Reduction. Note that all responders had RI value greater than 0.84, as indicated by the dashed red line, and all non-responders had RI less than this value.Conclusion: RI was significantly higher in responders. This may represent an important patient selection factor for G-POEM going forwards. A higher RI indicates a more proximal burden of disease. Perhaps the effect of pyloromyotomy goes beyond local distensibility, similarly to how fundic distension can induce antroduodenal motor activity. Larger, prospective studies are warranted to further explore RI as a criterion for G-POEM selection and the correlation between anatomical retention and motor activity. G-POEM has a clear, measurable effect on gastric emptying as shown by the decrease in RI following the procedure. Regional retention patterns may not correlate well with gastroparesis symptoms.

Factors Associated With Loss of Clinical Response to Gastric Per-Oral Endoscopic Pyloromyotomy (GPOEM) for Refractory Gastroparesis

Factors Associated With Loss of Clinical Response to Gastric Per-Oral Endoscopic Pyloromyotomy (GPOEM) for Refractory Gastroparesis

Diabetic gastroparesis: current challenges and future prospects.

Diabetic gastroparesis (DMGP) is a condition of delayed gastric emptying after gastric outlet obstruction has been excluded. Symptoms of nausea, vomiting, early satiety, bloating, and abdominal pain are associated with DMGP. Uncontrolled symptoms can lead to overall poor quality of life and financial burdens on the healthcare system. A combination of antiemetics and prokinetics is used in symptom control; metoclopramide is the main prokinetic available for clinical use and is the only U.S. Food and Drug Administration-approved agent in the United States. However, a black box warning in 2009 reporting its association with tardive dyskinesia and recommending caution in chronically using this agent beyond 3 months has decreased its role in clinical practice. There is an unmet need for new prokinetics with good efficacy and safety profiles. Currently, there are several new drugs with different mechanisms of action in the pipeline that are under investigation and show promising preliminary results. Surgically combining gastric electrical stimulation with pyloroplasty is considered “gold” standard. Advances in therapeutic endoscopic intervention with gastric per-oral endoscopic pyloromyotomy have also been shown to improve gastric emptying and gastroparesis (GP) symptoms. In this review, we will comment on the challenges encountered when managing patients with DMGP and provide an update on advances in drug development and endoscopic and surgical interventions.

State of the art review with literature summary on gastric peroral endoscopic pyloromyotomy for gastroparesis.

Gastroparesis is a debilitating progressive disease that significantly impacts a patient's life with limited and challenging treatments available. Although the pathogenesis is multifactorial, pylorospasm is believed to have a major underlying role. Several therapeutic interventions directed to the pylorus have been developed over the last decade, including intra-pyloric injections of botulinum toxin, transpyloric stenting, and surgical pyloroplasty. All of these treatment options had limited and disappointing results. More recently, gastric peroral endoscopic myotomy (G-POEM) has been reported as a treatment for refractory gastroparesis. In this review article, we provide an overview on gastroparesis with a focus on the therapeutic interventions. In addition, we provide a literature summary and pool analysis of the clinical efficacy, scintigraphic efficacy, and safety profile of all studies that evaluated G-POEM in gastroparesis. Overall, seven studies have reported on the use of G-POEM in gastroparesis, and the pooled analysis of these studies showed a technical success of 100%, with clinical efficacy as assessed by the Gastroparesis Cardinal Symptoms Index of 81.5%, gastric emptying scintigraphy normalization in approximately 55.5% of the cases, perioperative complications in 7.6%, and intraoperative complications in 6.6%. This suggests that G-POEM is a new promising therapeutic intervention for the treatment of gastroparesis with durable effect and limited potential adverse events.

Gastric Peroral Endoscopic Pyloromyotomy Reduces Symptoms, Increases Quality of Life, and Reduces Health Care Use For Patients With Gastroparesis

Gastric peroral endoscopic pyloromyotomy (GPOEM) is becoming a promising treatment option for patients with refractory gastroparesis. We aimed to systematically assess the efficacy of GPOEM and its effects on health care use. We performed a retrospective study on 30 patients with refractory gastroparesis who underwent GPOEM from June 2015 through July 2017 at a tertiary center. We compared outcomes with those of 7 patients with refractory gastroparesis who did not undergo the procedure (controls). The primary outcomes were patient-reported reductions in symptoms, based on the gastroparesis cardinal symptom index (GCSI), and increases in 8 aspects of quality of life, based on Short Form 36 (SF-36) scores. Data were collected on the day of the procedure (baseline) and at 1 month, 6 months, 12 months, and 18 months afterward. Secondary outcomes included visits to the emergency department or hospitalization for gastroparesis-related symptoms. GPOEM was technically successful in all patients and significantly reduced GCSI scores in repeated-measure analysis of variance (F2.044, 38.838= 22.319; P < .0005). The mean score at baseline was 3.5 ± 0.6, at 1 month after GPOEM was 1.8 ± 1.0 (P < .0005), at 6 months after was 1.9 ± 1.2 (P < .0005), at 12 months after was 2.6 ± 1.5 (P < .026), and at 18 months after was 2.1 ± 1.3 (P < .016). GPOEM was associated with improved quality of life: 77.8%, 76.5%, and 70% of patients had significant increases in SF-36 scores, compared with baseline, at 1 month, 6 months, and 12 months after GPOEM, respectively (F1.71,18.83= 14.16; P < .0005). Compared with controls, patients who underwent GPOEM had significant reductions in GCSI, after we controlled for baseline score and duration of the disease (F1,31= 9.001; P= .005). Patients who received GPOEM had significant reductions in number of emergency department visits (from 2.2 ± 3.1 times/mo at baseline to 0.3 ± 0.8 times/mo; P= .003) and hospitalizations (from 1.7 ± 2 times/mo at baseline to 0.2 ± 0.4 times/mo; P= .0002). In a retrospective study of patients who underwent GPOEM for refractory gastroparesis, we found the procedure significantly improved symptoms, increased quality of life, and reduced health care use related to gastroparesis.

Gastric peroral endoscopic myotomy for the treatment of refractory gastroparesis: a multicenter international experience.

Gastroparesis is a difficult-to-treat motility disorder with a poor response to medical therapy. Gastric peroral endoscopic pyloromyotomy (G-POEM) has been offered as a novel therapy in the treatment of refractory gastroparesis. We present a multicenter case series of our experience with G-POEM. This is an international multicenter case series of patients who underwent G-POEM for the treatment of gastroparesis. The severity of gastroparesis was assessed by delayed gastric emptying scintigraphy (GES) and an elevated gastroparesis cardinal symptoms index (GCSI). Patients then underwent G-POEM using the submucosal tunneling technique. The primary endpoint was improvement in the GCSI score and improvement in gastric emptying on repeat scintigraphy. Secondary endpoints were technical success, complication rate, procedure duration, and length of hospital stay post-procedure. G-POEM was technically successful in all 33 patients. Symptomatic improvement was seen in 28/33 patients (85 %), with a decrease in symptom score by GCSI from 3.3 to 0.8 at follow-up (P < 0.001). The mean procedure duration was 77.6 minutes (37 - 255 minutes). Mean GES improved significantly from 222.4 minutes to 143.16 minutes (P < 0.001). Complications were minimal and included bleeding (n = 1) and an ulcer (n = 1) treated conservatively. The mean length of hospital stay post-procedure was 5.4 days (1 - 14 days). The mean follow-up duration was 11.5 months (2 - 31 months). G-POEM is a technically feasible, safe, and successful procedure for the treatment of refractory gastroparesis. A further multicenter comparative study should be performed to compare this technique to laparoscopic pyloromyotomy.

Current Status of Peroral Endoscopic Myotomy.

Peroral endoscopic myotomy (POEM) has been established as an optional treatment for achalasia. POEM is an endoluminal procedure that involves dissection of esophageal muscle fibers followed by submucosal tunneling. Inoue first attempted to use POEM for the treatment of achalasia in humans. Expanded indications of POEM include classic indications such as type I, type II, type III achalasia, failed prior treatments, including Botulinum toxin injection, endoscopic balloon dilation, laparoscopic Heller myotomy, and hypertensive motor disorders such as diffuse esophageal spasm, jackhammer esophagus. Contraindications include prior radiation therapy to the esophagus and prior extensive esophageal mucosal resection/ablation involving the POEM field. Most of the complications are minor and self-limited and can be managed conservatively. As POEM emerged as the main treatment for achalasia, various adaptations to tunnel endoscopic surgery have been attempted. Tunnel endoscopic surgery includes POEM, peroral endoscopic tumor resection, gastric peroral endoscopic pyloromyotomy. POEM has been widely accepted as a treatment for all types of achalasia, even for specific cases such as achalasia with failed prior treatments, and hypertensive motor disorders.

Fluoroscopic gastric peroral endoscopic pyloromyotomy (G-POEM) in patients with a failed gastric electrical stimulator

BackgroundGastric electrical stimulators (GESs) have been used to treat refractory gastroparesis in patients who fail initial therapies such as dietary modifications, control of psychological stressors and pharmacologic treatment. More recently, gastric peroral endoscopic pyloromyotomy (G-POEM) has emerged as a novel endoscopic technique to treat refractory gastroparesis. We present a case series of patients with refractory gastroparesis who failed treatment with an implanted GES that were safely treated with G-POEM performed under fluoroscopy as a salvage therapy.MethodsCases of G-POEM performed on patients with refractory gastroparesis who failed treatment with a GES were retrospectively reviewed. All G-POEM procedures were performed under fluoroscopic guidance with the GES still in place. Gastroparesis Cardinal Symptoms Index (GCSI) and gastric emptying scintigraphy were assessed before and after the procedure. Patients were followed up for up to 18 months post procedure.ResultsFive patients underwent G-POEM after failing treatment with a GES. Under fluoroscopy, the GES and their leads were visualized in different parts of the stomach. One GES lead was observed at the antrum near the myotomy site. All procedures were successfully completed without complications. Patients’ GCSI decreased by an average of 62% 1 month post procedure. Patients also had notable improvements in gastric emptying 2 months post procedure.ConclusionIn patients with refractory gastroparesis who have failed treatment with a GES, G-POEM can be safe and effective without removing the GES. To visualize the GES and avoid cutting GES leads during myotomy, the procedure should be performed under fluoroscopy.

Effect of Gastroparesis Etiology on Clinical Response to Gastric Peroral Endoscopic Pyloromyotomy (GPOEM)

Introduction: Gastroparesis is a heterogenous disorder with broad clinical spectrum. Etiology of gastroparesis was shown to influence clinical severity and response to therapy. Gastric per oral endoscopic pyloromyotomy (GPOEM) has shown an exciting success in treatment of refractory gastroparesis but its clinical impact on different subtypes of gastroparesis is currently unknown. This study aims to evaluate clinical responses of GPOEM based on etiology of gastroparesis. Methods: This retrospective cohort study was conducted in patients with refractory gastroparesis who underwent GPOEM. Symptoms and quality of life were scored using Gastroparesis Cardinal Symptom Index (GCSI) and a short-form 36 questionnaire (SF36) before and after the procedure at 1, 6, and 12-month. Gastric emptying scintigraphy (GES) was obtained at baseline and at 8 weeks. Comparative analysis of clinical outcomes was performed. Results: 12 patients with diabetic gastroparesis (DG), 12 patients with idiopathic gastroparesis (IG), and 5 patients with post-surgical gastroparesis (PG) were included. There was no statistically significant difference in baseline disease severity across all group, measured by GCSI (F=0.04; p=0.96), SF36 (F=0.24; p=0.79), and GES (F=1.48; p=0.28). DG cohort had significantly longer duration of the disease (6.7+/-3.8 years), compared to IG (t=1.92; p=0.03) and PG group (t=-2.2; p=0.01). Overall, 76.9% of patients achieved clinical response. All group had statistically significant improvement in GES, GCSI, and SF36. There was no significant difference on degree of improvement of GES (F=0.3; p=0.74), GCSI (F=0.09; p=0.91), and SF36 (F=1.14; p=0.33) at 1-month post GPOEM among 3 groups. There was no significant difference on the improvement of GCSI and SF36 between DG and IG at both 6-month (t=0.18; p=0.85 and t=-1.4; p=0.18) and 12-month post procedure (t=-0.5; p=0.6 and t=0.58; p=0.58). Subgroup analyses of clinical responses on each primary symptom of nausea, early satiety, bloating, and pain did not show any significant differences among DG, IG, and PG cohort. Conclusion: GPOEM resulted in improved GSCI and quality of life that sustained throughout a 12-month period in all subtype of gastroparesis, including DG, IG and PG, with a similar degree of improvement. Despite a greater decrease in nausea and early satiety, compared to bloating and pain, they did not reach statistical significance in subgroup analyses. Larger studies are warranted to determine factors associated with favorable outcomes.Figure: Improvement of GCSI after GPOEM in each subtype of gastroparesis;GCSI: gastroparesis cardinal symptoms index; GPOEM: gastric per oral endoscopic pyloromyotomy.Figure: Improvement of quality of life after GPOEM in each subtype of gastroparesis;SF36: Short form 36; GPOEM: gastric per oral endoscopic pyloromyotomy.Figure: Improvement of GES after GPOEM in each subtype of gastroparesis;GES: gastric emptying scintigraphy; GPOEM: gastric per oral endoscopic pyloromyotomy; DG: diabetic gastroparesis; IG: idiopathic gastroparesis; PG: post-surgical gastroparesis.

Choosing An Optimal Tool for Monitoring Clinical Response in Gastroparesis After Gastric Peroral Endoscopic Pyloromyotomy: A Correlational Study Between Gastric Emptying Scintigraphy and Patient Reported Outcomes

Introduction: Gastroparesis is a debilitating disease with a complex pathophysiology, chronic, relapsing course, rendering inconsistent responses to available treatments. Gastric Per Oral Endoscopic Pyloromyotomy (GPOEM) is a novel endoscopic procedure with exciting potential to become the forefront of gastroparesis treatment. However, one of the challenges in managing gastroparesis is the lack of standardized monitoring tools. This study aims to assess this critical aspect of outcome evaluation by comparing patient-reported clinical metrics and gastric emptying scintigraphy (GES).Figure: Improvement of GCSI after GPOEM during a 12-month follow upFigure: Correlation between GES and patient-reported outcomes as measured by GCSI and SF36;GCSI: gastroparesis cardinal symptoms index; GPOEM: gastric per oral endoscopic pyloromyotomy; SF36: Short form 36; GES: gastric emptying scintigraphy; QoL: quality of life; K-correlation: kappa correlation.Figure: Correlation between patient reported outcomes (GCSI and SF36) after GPOEM; GCSI: gastroparesis cardinal symptoms index; GPOEM: gastric per oral endoscopic pyloromyotomy; SF36: Short form 36; K-correlation: kappa correlation.Methods: This is a retrospective correlational study on outcomes of GPOEM performed from June 2015 to February 2017. GES was obtained at baseline and at 8-week post procedure. Agreements among GES, gastroparesis cardinal symptoms index (GCSI), and quality of life, measured by standardized short-form 36 (SF36) at 1, 6, and 12-month post GPOEM were evaluated. Results: 28 patients with refractory gastroparesis were included. Mean gastric retention at 4-hour GES significantly decreased from baseline of 63.0+/-25.2% to 22.2+/-20.5% (p50% reduction) in 78.3% and has normalized in 47.8% of patients, while GCSI has improved in 76.6%, 80%, and 72.7% of patients at 1, 6, and 12-month post-GPOEM, respectively. Improvement of GES had moderate agreement with both GCSI and SF36 at 1 month post-procedure (K=0.49+/-0.2 and K=0.48+/-0.25). The strength of agreement between GES and SF36 (good agreement at both 6-month and 12-month; K=0.76+/-0.22 and K=0.6+/-0.23) appeared to be better compared to agreement between GES and GCSI (fair agreement K=0.39+/-0.24 at 6-month and moderate agreement K=0.42+/-0.3 at 12-month). Between patient-reported outcomes, GCSI had moderate agreement with SF36 at 1-month and 6-month (K=0.57+/-0.19 and K=0.6+/-0.24) and good agreement at 12-months (K=0.6+/-0.2, 95%CI 0.15-1.0). Conclusion: The inconsistent correlations between GES and patient-reported outcomes found in our study questioned the validity of GES to predict clinical response to gastroparesis treatment. As symptomatic improvement is the main goal of therapy, the role of GES for disease monitoring is unclear and should be used as a reference. With moderate-to-good agreement between GCSI and SF36 and the fact that they were designed to assess different clinical parameters, we believe that both scoring tools are equally important and should be adopted in assessment of therapeutic efficacy of gastroparesis.

Patient-Reported Quality of Life Assessment and Utilization of Health Care After Gastric Peroral Endoscopic Pyloromyotomy (GPOEM): 2017 Fellows-in-Training Award (Interventional Endoscopy Category)

Introduction: Current therapy for gastroparesis is limited, often times ineffective and results in frequent emergency room visits and hospitalizations. Gastric per oral endoscopic pyloromyotomy (GPOEM) is a promising treatment option for refractory gastroparesis. Due to its novelty, the existing data on long-term clinical outcomes and its impact on healthcare are lacking. This study aims to systematically assess the efficacy and safety of GPOEM using patient-reported metrics and utilization of health care.Figure: Improvement of GCSI after GPOEM GCSI: Gastroparesis cardinal symptom index.Figure: Improvement of GCSI after GPOEM GCSI: Gastroparesis Cardinal Symptom Index.Figure: Improvement of quality of life after GPOEM PF: physical functioning; RP: role limitation due to physical health; BP: bodily pain; GH: general health; VT: vitality; SF: social functioning; RE: role limitation due to emotional problems; MH: mental health.Methods: We performed a retrospective cohort study on outcomes of GPOEM on patients with refractory gastroparesis. Patient-reported gastroparesis cardinal symptoms index (GCSI), quality of life metrics assessed by standardized short-form 36 (SF36), and utilization of health care were collected at 0, 1, 6, 12, and 18-month after the procedure. Results: 30 patients with refractory gastroparesis who underwent GPOEM were included. GPOEM was technically successful in all patients. Mean gastroparesis cardinal symptom index (GCSI) decreased from 3.6+/-0.6 at baseline to 1.74+/-1.0 at 1-month (p < 0.00001), 1.7+/-1.1 at 6-month (p < 0.00001), 1.8+/-1.4 at 12-month (p=0.002), and 1.4+/-1.3 at 18-month (p=0.016) post-GPOEM with nausea and early satiety being the symptoms with highest response rate (p=0.0046 and 0.03). Significant improvements in quality of life in several domains were observed with 77.8%, 76.5%, 70%, and 83.3% of patients improved at 1, 6, 12, and 18-month after the procedure, respectively. 55.5% and 52.9% of patients had significantly improved pain at 1 and 6-month follow up (p=0.001 and 0.01), while only 40% and 33.3% reported better pain control at 12 and 18-month but with a nonsignificantly improved pain score (p=0.13 and 0.86). There was a significant decrease in the emergency room visit rate for gastroparesis-related symptoms from 2.2+/-3.1 to 0.3+/-0.8 times/month (p=0.003), while hospitalization rate significantly decreased from 1.7+/-2 to 0.2+/-0.4 times/month (p=0.0002). Only one patient (3.3%) had a complication with a tension capnoperitoneum requiring needle decompression. Conclusion: GPOEM results not only in clinical improvement that sustained throughout an 18-month period, but also significantly decreased utilization of healthcare resources and an improvement in overall quality of life. It is a therapeutic option for patients with refractory gastroparesis who have nausea/vomiting or early satiety as predominating symptoms, but less for bloating and pain.

Procedural Characteristics and Relation to Clinical Outcomes in Gastric Peroral Endoscopic Pyloromyotomy (GPOEM) for Refractory Gastroparesis

Introduction: Refractory gastroparesis has shown encouraging response to the emerging gastric peroral endoscopic pyloromyotomy (GPOEM) procedure. GPOEM is technically similar to POEM for achalasia; however, the focus is on pyloromyotomy for improved stomach emptying. This study assesses procedural characteristics of GPOEM and the relation to clinical outcomes in patients with refractory gastroparesis. Methods: This study was a case-control retrospective analysis of 14 total patients who underwent GPOEM from June 2015 to July 2016 for refractory gastroparesis. Seven patients were grouped based on failed clinical response to the procedure, as defined by: (1) less than 20% decrease in Gastroparesis Cardinal Symptom Index (GCSI) score after one month, (2) gastric retention at 4 hours failed to decreased by 50% during gastric emptying study, or (3) Short Form 36 score did not increase by 25% overall or by more than 50% in three or more individual categories. We compared these seven patients with seven pre-procedural GCSI-matched patients who achieved improvement based on the above criteria. Procedural parameters, including timing of procedure, i.e. performed during the first 10 cases within first six months or learning curve period, participation of an advanced endoscopy fellow/trainee, and the length of myotomy, were compared between the two groups using bivariate analysis. Results: Age, gender, and race were matched between the two groups. The average pre-GPOEM GCSI score for non-responders was 31.7 ± 5.1 and for responders was 32.0 ± 4.7 (p=0.36). Number of the procedures performed during the learning curve period was not significantly different between the two groups (p=0.17) and none of the seven patients who failed to respond to GPOEM underwent their procedure during this period. An advanced endoscopy fellow/trainee participated in all 14 cases. Mean myotomy length was longer for non-responders (2.92 ± 0.19 cm) compared with 2.71 ± 0.39 cm for responders but did not reach statistical significance (p=0.07). Conclusion: It does not appear that timing of GPOEM, in terms of being performed within the learning curve period, or participation of a trainee significantly affects outcomes. There may be an association of increasing myotomy length and lack of clinical improvement following the procedure, however, this trend did not reach statistical significance. We suspect that antral contractility, and thus stomach emptying, may be adversely affected by longer myotomy length.Table: Table. Procedural Characteristics of Included Cases