Gastroparesis Cardinal Symptom Index Score Research Articles

Short-term symptomatic outcomes of GERD in patients with gastroparesis after gastric per oral endoscopic pyloromyotomy.

Gastroparesis (Gp) patients often have gastroesophageal reflux disease (GERD). Management of GERD in Gp patients is a challenge. Many studies have shown that gastric peroral endoscopic pyloromyotomy (G-POEM or POP) is moderately effective in reducing nausea and vomiting in patients with Gp. This study aims to determine whether G-POEM can improve GERD in Gp Patients. Patients who underwent G-POEM from July 2021 to October 2022 were enrolled in the study. GERD Health-Related Quality of Life (GERD HRQL) and Reflux Symptom Index (RSI) were used to assess patients' GERD before and after G-POEM. The use of proton pump inhibitors (PPIs) before and after G-POEM were also documented. The Gastroparesis Cardinal Symptom Index (GCSI) was used to assess the severity of Gp before and after G-POEM. A 'Welch two-sample t-test' was used to find differences in GERD HRQL (health-related quality of life) and RSI scores before and after the procedure. Pearson's chi-square test was used to find differences for use of PPI before and after G-POEM. Twenty-three consecutive refractory Gp patients with 30% male (average age 63.2) and 70% female patients (average age 53.9) were enrolled. Of these, 14 had diabetes, 3 had a history of surgery, and 6 had idiopathic Gp. The mean follow-up was 41days (range 7-61days). There was a significant decrease in the mean GERD HRQL score from 16.5 to 6.5 after G POEM with a P-value <0.0001 (95% level of significance) and a significant decrease in mean RSI score from 15.3 to 5.2 after G-POEM with P-value <0.0001 (95% level of significance). The proportion of use of PPI before GPOEM was 0.91, and the proportion of PPI use after GPOEM was 0.43 (P = 0.0008). The mean GCSI pre- and post-GPOEM were 3.53 and 1.59, respectively. Eighteen had clinical success in Gp as defined by decreased mean GCSI score greater than 1. In this short-term outcome study, 87% of patients' GERD HRQL scores and RSI scores decreased after G-POEM. These findings indicate that GPOEM not only effectively reduces Gp symptoms but also improves GERD symptoms leading to decreased or more effective use of PPI in these patients. To our knowledge, this is the first study to comprehensively show G-POEM significantly improves GERD. Further studies with a larger patient population and long-term outcomes are needed.

Efficacy of gastric stimulator as an adjunct to pyloroplasty for gastroparesis: characterizing patients suitable for single procedure vs dual procedure approach

BackgroundPyloroplasty is an effective surgery for gastroparesis. However, some patients fail to improve after pyloric drainage and may require subsequent gastric electric stimulation. There is a paucity of data on the efficacy of gastric stimulator as an adjunct to failed pyloroplasty. This study aimed to describe our experience with pyloroplasty, determine the efficacy of gastric stimulator for failed pyloroplasty, and compare the final outcomes of those who required pyloroplasty with and without gastric stimulator for gastroparesis. MethodsRecords of patients who underwent primary pyloroplasty for gastroparesis at our institution were reviewed. Patients with poor symptomatic improvement after pyloroplasty underwent subsequent gastric stimulator. Symptoms were assessed using the gastroparesis cardinal symptom index (GCSI) preoperatively and after each surgery. Severe gastroparesis was defined as GCSI total score ≥3. Outcomes were assessed after pyloroplasty in all patients and after stimulator in patients who failed pyloroplasty. Final outcomes were then compared between those who did and did not require adjunct gastric stimulator. ResultsThe study population consisted of 104 patients (89.4% females) with a mean (SD) age of 42.2 years (11) and body mass index of 26.9 kg/m2 (7). Gastroparesis etiologies were 71.2% idiopathic, 17.3% diabetic, and 11.5% postsurgical. At 18.7 months (12) after pyloroplasty, there was a decrease in the GCSI total score (3.5 [1] to 2.7 [1.2]; P = .0012) and the rate of severe gastroparesis (71.9%−29.3%; P < .0001). Gastric emptying scintigraphy (GES) 4-hour retention decreased (36.5 [24] to 15.3 [18]; P = .0003).Adjunct gastric stimulator was required by 30 patients (28.8%) owing to suboptimal outcomes with no improvement in GCSI (P = .201) or GES (P = .320). These patients were younger (40.5 [10.6] vs 49.6 [15.2] years; P = .0016), with higher baseline GCSI total scores (4.3 [0.7] vs 3.7 [1.1]; P < .001) and more severe gastroparesis (100% vs 55.6%; P < .001). All other preoperative characteristics were similar. At 21.7 months (15) after gastric stimulator, there was improvement in GCSI (4.1 [0.7] to 2.6 [1.1]; P < .0001), severe gastroparesis (100%−33.3%; P < .0001), and GES 4-hour retention (21.2 [22] to 7.6 [10]; P = .054). Before gastric stimulator, those who failed pyloroplasty had significantly worse GCSI (P = .0009) and GES (P = .048). However, after gastric stimulator, GCSI and GES improved and were comparable with those who only required pyloroplasty (P > .05). ConclusionPyloroplasty improved gastroparesis symptoms and gastric emptying, yet 28% failed, requiring gastric stimulator. Younger patients and those with preoperative GCSI scores ≥3 were more likely to fail. Gastric stimulator improved outcomes after failed pyloroplasty, with comparable final GCSI and GES with those who did not fail.

Symptoms from the Gastroparesis Cardinal Symptom Index and clinical factors associated with delayed gastric emptying in patients with suspected gastroparesis.

The association between upper gastrointestinal symptoms and delayed gastric emptying (GE) shows conflicting results. This study aimed to assess whether the symptoms of the Gastroparesis Cardinal Symptom Index (GCSI) and/or the scores were associated with the result of GE tests and whether they could predict delayed GE. Patients referred for suspected gastroparesis (GP) were included in a prospective database. Demographical data, medical history, and symptoms of the GCSI score were collected for each patient. A GE scintigraphy was then performed with a 4-hour recording. Delayed GE was defined as a retention rate ≥ 10% at 4 h. Among 243 patients included in this study, 110 patients (45%) had delayed GE. The mean age (49.9 vs. 41.3 years; p < 0.001) and weight loss (9.4 kg vs. 5.6 kg; p = 0.025) were significantly higher in patients with delayed GE. Patients with diabetes or a history of surgery had a higher prevalence of delayed GE (60% and 78%, respectively) than patients without comorbidity (17%; p < 0.001). The GCSI score was higher in patients with delayed GE (3.06 vs. 2.80; p = 0.045), but no threshold was clinically relevant to discriminate between patients with normal and delayed GE. Only vomiting severity was significantly higher in patients with delayed GE (2.19 vs. 1.57; p = 0.01). GE testing should be considered when there are symptoms such as a higher weight loss, comorbidities (diabetes, and history of surgery associated with GP), and the presence of vomiting. Other symptoms and the GCSI score are not useful in predicting delayed GE.

Efficacy and Safety of Gastric Per-Oral Endoscopic Myotomy (G-POEM): A Systematic Review and Meta-Analysis.

Gastric per-oral endoscopic myotomy (G-POEM) is an innovative treatment that has become increasingly utilized for patients with refractory gastroparesis. The aim of this systematic review and meta-analysis was to evaluate the safety and effectiveness of G-POEM for the treatment of gastroparesis. Individualized search strategies were developed through February 2021 in accordance with the PRISMA and MOOSE guidelines. This meta-analysis was performed by calculating pooled proportions and mean difference preprocedure and postprocedure with rates estimated using random effects models. Measured outcomes included technical success, clinical success, improvement in gastroparesis cardinal symptom index (GCSI), change in gastric emptying rate, alterations in impedance planimetry (functional lumen imaging probe [FLIP]) assessment, and adverse events. A total of 20 studies (n=797 patients; 67.41% female) were included. The mean age was 48.92±11.61 y, with an average duration of 4.24±1.11 y since gastroparesis diagnosis. Technical success was 98.47% [(95% CI: 97.14, 99.19);I2=0.00] with a mean myotomy length of 3.78±1.16cm. In terms of clinical success, mean preprocedure GCSI scores were 3.38±0.37 and improved significantly postprocedure [weighted mean difference -1.56 (95% CI: -1.89 to -1.24); I2=82.53; P<0.001]. Gastric retention after 4 hours demonstrated ~50% improvement (preprocedure 43.08±9.24% versus postprocedure 22.97±10.19%; P<0.001). FLIP assessment with 40mL and 50mL balloons demonstrated a significant increase in diameter, distensibility index, and cross-sectional area postprocedure (all P<0.05). Procedure-associated adverse events occurred among 10.92% [(95% CI 5.09 to 19.32); I2=82.85] of patients. G-POEM appears safe and highly effective for the treatment of patients with refractory gastroparesis regardless of symptom predominance or etiology.

Clinical Outcomes of a Large, Prospective Series of Gastric Electrical Stimulation Patients Using a Multidisciplinary Protocol.

Gastric electrical stimulation (GES) is an intervention used in the treatment of medically refractory gastroparesis. There are few large series demonstrating efficacy over a long-term follow-up period. This study reports clinical outcomes for patients from a single institution for up to 5 years. A prospective database of patients undergoing GES implantation for gastroparesis was collected and reviewed. Patients were selected according to a multidisciplinary institutional protocol. Baseline characteristics, including age, sex, smoking history, etiology of gastroparesis, and duration of gastroparesis symptoms, were collected. Symptomatic response was evaluated using Gastroparesis Cardinal Symptom Index (GCSI) surveys preoperatively and at subsequent follow-up visits. Other clinical outcome variables include medication use, hospitalizations due to gastroparesis, and overall satisfaction with symptom relief. Patient outcomes regarding reoperation and explantation were also recorded. A total of 157 patients have undergone GES at our institution since 2012. GCSI scores were collected in all patients at baseline, in 141 patients at 1-year follow-up, and in 110 patients at 5-year follow-up. Symptom severity in all 9 gastroparesis symptoms evaluated by the GCSI, as well as the total GCSI score, was reduced significantly at 1 year postoperatively, and these results were sustained at 5-year follow-up. Use of prokinetic and antiemetic medications was reduced during the follow-up period. Hospitalizations due to gastroparesis symptoms were also reduced. GES devices were explanted in 5 patients, 12 patients required generator exchanges, and 7 patients required reoperation due to displaced or eroded device leads during the study period. GES is associated with sustained symptomatic relief, reduced reliance on medications, and reduced hospitalizations in gastroparesis patients selected using our institutional protocol.

Effects of stimulating single acupoint and combination acupoints on diabetic gastroparesis: A randomised controlled trial study

Background and aimThe most effective among the acupoints remains to be determined for treating diabetic gastroparesis (DGP). This study aimed to compare single and combination acupoints for their effectiveness in DGP. Experimental procedureA prospective, patient-assessor-blinded randomised controlled trial was designed to compare the efficacy of 8-week acupuncture at a single acupoint (Zhongwan, CV-12), combination acupoints (Zhongwan, CV-12 and Zusanli, ST-36), and a sham-acupoint, in 99 adults with DGP. The primary clinical outcome was measured using the Gastroparesis Cardinal Symptom Index (GCSI), while barium meal examination, fasting plasma glucose, the 2-h plasma glucose, short-form health survey (SF-36), and GCSI subscales were performed for evaluating secondary clinical outcomes. These results were analysed by two factorial analysis of variance (ANOVA) test, Chi-Square, Fisher Exact, Kruskal–Wallis tests and Tukey's Honest Significant Difference (HSD) test. ResultsAfter randomization, 97 patients completed the study. GCSI scores of all groups decreased during both post-treatment and the follow-up period, they were statistically significant compared to the baseline period (p < 0.01), but there was no significant difference among the groups (p > 0.05) during the post-treatment period. GCSI scores improved more in the combination acupoints group than in the single acupoint group which was better than the sham group after treatment. During the follow-up period, the same trend was observed. ConclusionsAmong patients with DGP, the combination acupoints were more beneficial compared with single and sham acupoints. Trial registration numberNCT02452489.

Efficacy of Pistacia lentiscus Plant (Rumi Mastagi) in Comparison to Levosulpiride in Patients with Diabetic Gastroparesis: A Double-Blind Non-Inferior Randomised Control Trial Study.

Gastrointestinal neuropathies are frequently found in diabetic patients. The pathogenesis of diabetic gastroparesis (DG) is multifactorial. The usual treatment for DG includes dietary modifications, prokinetic and antiemetic agents. There is increasing demand for more effective medicines to treat DG. The current study was conducted on the Pistacia lentiscus stem extract to add to the armamentarium of DG treatment and to find the efficacy of P. lentiscus plant extract (mastic gum) in comparison to levosulpiride in DG for improvement in gastroparesis symptoms and gastric emptying scintigraphy (GES) in a single centric double-blind non-inferiority randomised control trial. Thirty-eight individuals were recruited and equally randomised into two study groups based on Gastroparesis Cardinal Symptom Index (GCSI) score and TC99 Radionuclide GES, mastic gum group and levosulpiride group. Both pre and post-intervention (8 weeks) GCSI scores were calculated, GES was performed to quantify the improvement in gastric emptying. Power analysis was performed using G*POWER software version 3.1.9.7 and data analysis using SPSS 23.0, variables measured in mean ± standard deviation (SD). Various statistical tests were used such as independent t-test, Chi-square test or Fisher's exact test, Wilcox Mann-Whitney test, analysis of variance (ANOVA) test, and posthoc pairwise tests. The mastic gum is found effective in the improvement of 4 h gastric emptying percentage from the mean (SD) 76.60 (± 9.96) to mean (SD) 97.20 (2.17)% (P < 0.001). Mastic gum has the property of HbA1c reduction, which is more significant than that of levosulpiride (P = 0.044). Mastic gum also had significant Low density lipoprotein (LDL) (mg/dL) levels reduction, (P < 0.001), compared to levosupiride. An absolute increase was observed in haemoglobin (HB) level in mastic gum at a 2-month mean (SD) of 1.03 (0.77) (g/dL) (P-value <0.001). To our knowledge, this is the first study to compare the effect of levosulpiride with mastic gum concerning improvement in diabetic gastroparesis (DG) using GES. In the study, mastic gum was found to have great properties to improve DG with many important pleiotropic effects.

The Efficacy of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Phase 3 Randomized Placebo-Controlled Clinical Trial

Neurokinin receptor 1 (NK1R) antagonists are effective in reducing nausea and vomiting in chemo-therapy induced emesis. We investigated the safety and efficacy of tradipitant, an NK1R antagonist, in patients with idiopathic and diabetic gastroparesis. 201 adults with gastroparesis were randomly assigned to oral tradipitant 85 mg (n = 102) or placebo (n = 99) twice daily for 12 weeks. Symptoms were assessed by a daily symptom dairy, Gastroparesis Cardinal Symptom Index scores, and other patient-reported questionnaires. Blood levels were monitored for an exposure-response analysis. The primary outcome was change from baseline to week 12 in average nausea severity, measured by daily symptom diary. The ITT population did not meet the pre-specified primary endpoint at Week 12 (difference in nausea severity change drug vs. placebo, P = .741) or pre-specified secondary endpoints. Post hoc analyses were performed to control for drug exposure, rescue medications, and baseline severity inflation. Subjects with high blood levels of tradipitant significantly improved average nausea severity beginning at early time points Weeks 2 through Week 4. In post hoc sensitivity analyses, tradipitant treatment demonstrated strengthened effects, with statistically significant improvements in nausea at Week 12. Although tradipitant did not reach significance in the ITT population, a pharmacokinetic exposure-response analysis demonstrated significant effects with adequate tradipitant exposure. When accounting for confounding factors such as baseline severity inflation and rescue medication, a statistically significant effect was also observed. These findings suggest that tradipitant has potential as a treatment for the symptom of nausea in gastroparesis. [ClincialTrials.gov number, NCT04028492].

Benefits of Prokinetics, Gastroparesis Diet, or Neuromodulators Alone or in Combination for Symptoms of Gastroparesis

Prokinetics have limited effectiveness for treating symptoms of gastroparesis. Thus, alternative or adjunct therapies, such as gastroparesis diets or neuromodulators, are often prescribed. Their therapeutic benefits alone or in combination remain unclear. One hundred and twenty-nine patients with symptoms of gastroparesis underwent wireless motility capsule gastric emptying time and gastric emptying scintigraphy. Based on test results, changes in therapy were recommended. Changes in Gastroparesis Cardinal Symptom Index (GCSI) and individual symptom scores over 6 months were related to recommendations for prokinetics, gastroparesis diet, or neuromodulators given as solo new therapies or in dual combinations. Multivariate analyses were performed to adjust for gastric emptying and other variables. In the whole group regardless of therapy, GCSI scores decreased by 0.53 points (interquartile range, -1.25 to 0.05; P < .0001) over 6 months. GCSI did not decrease for prokinetics as solo new therapy (P= .95). Conversely, neuromodulators as solo therapy decreased GCSI scores (P= .04) and all individual symptoms except nausea/vomiting (P= .86). Prokinetics combined with gastroparesis diets or neuromodulators improved GCSI scores (P ≤ .04) and most individual symptoms. Adjusting for gastric emptying time on multivariate analyses showed greater GCSI decreases for nondelayed emptying for neuromodulators as solo new therapy (P= .01). Gastric emptying scintigraphy, gender, diabetes, and functional dyspepsia did not influence responses to any treatment. Initiating prokinetics as solo new therapy had little benefit for patients with symptoms of gastroparesis. Neuromodulators as the only new therapy decreased symptoms other than nausea and vomiting, especially with nondelayed gastric emptying. Adding gastroparesis diets or neuromodulators to prokinetics offered relief, suggesting that combination therapies may be more useful in managing these patients. (ClinicalTrials.gov NCT02022826.).

Topic: StomachAbstract ID: 88Is There a Difference in Subjective and Objective Outcomes of Pyloroplasty for Gastroparesis Based on Pre-op Gastroparesis Cardinal Symptom Index Score and Nuclear Medicine Gastric Emptying Study?

Topic: StomachAbstract ID: 88Is There a Difference in Subjective and Objective Outcomes of Pyloroplasty for Gastroparesis Based on Pre-op Gastroparesis Cardinal Symptom Index Score and Nuclear Medicine Gastric Emptying Study?

A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis

Cannabis (delta-9-tetrahydrocannabinol), a nonselective cannabinoid-receptor agonist, relieves nausea and pain. Cannabidiol (CBD), a cannabinoid receptor 2 inverse agonist with central effects, also reduces gut sensation and inflammation. We compared the effects of 4 weeks of treatment with pharmaceutical CBD vs placebo in patients with idiopathic or diabetic (diabetes mellitus) gastroparesis. We performed a randomized, double-blinded, placebo-controlled study of CBD twice daily (Epidiolex escalated to 20 mg/kg/d; Jazz Pharmaceuticals, Dublin, Ireland) in patients with nonsurgical gastroparesis with delayed gastric emptying of solids (GES). Symptoms were assessed by the Gastroparesis Cardinal Symptom Index Daily Diary. After 4 weeks of treatment, we measured GES, gastric volumes, and Ensure (Abbott Laboratories, Abbott Park, IL) satiation test (1 kcal/mL, 30 mL/min) to assess volume to comfortable fullness and maximum tolerance. Patients underwent specific FAAH and CNR1 genotyping. Statistical analysis compared 2 treatments using analysis of variance including baseline measurements and body mass index as covariates. Among 44 patients (32 idiopathic, 6 diabetes mellitus type 1, and 6 diabetes mellitus type 2), 5 patients did not tolerate full-dose escalation; 3 withdrew before completing 4 weeks of treatment (2 placebo, 1 CBD); 95% completed 4 weeks of treatment and diaries. Compared with placebo, CBD reduced the total Gastroparesis Cardinal Symptom Index score (P= .008), inability to finish a normal-sized meal (P= .029), number of vomiting episodes/24 hours (P= .006), and overall symptom severity (P= .034). Patients treated with CBD had a higher volume to comfortable fullness and maximum tolerance and slower GES. FAAH rs34420 genotype significantly impacted nutrient drink ingestion. The most common adverse events reported were diarrhea (14 patients), fatigue (8 patients), headache (8 patients), and nausea (7 patients). CBD provides symptom relief in patients with gastroparesis and improves the tolerance of liquid nutrient intake, despite slowing of GES. gov NCT #03941288.

Bariatric endoscopic antral myotomy: first-in-human proof of concept of a novel therapeutic method to delay gastric emptying and induce weight loss

Bariatric endoscopic antral myotomy: first-in-human proof of concept of a novel therapeutic method to delay gastric emptying and induce weight loss

Is vitamin B12 deficiency a risk factor for gastroparesis in patients with type 2 diabetes?

BackgroundDiabetic gastroparesis is a severe diabetic complication refers to delayed gastric emptying in the absence of mechanical obstruction of the stomach. Vitamin B12 affects the dynamics of autonomic nervous system and its deficits has been linked to cardiovascular autonomic neuropathy therefore, vitamin B12 deficiency was hypothesized to be implicated in the development of diabetic gastroparesis. This study was conducted to explore the possible association between vitamin B12 deficiency and gastroparesis in patients with type 2 diabetes (T2D).MethodsA total of 100 T2D patients with diabetes duration > 10 years and 50 healthy controls matched for age and sex were recruited for this study. T2D patients were divided into 2 groups: patients with gastroparesis and patients without gastroparesis. The diagnosis of gastroparesis was based on Gastroparesis Cardinal Symptom Index (GCSI) Score ≥ 1.9 and ultrasonographic findings including gastric emptying ˂ 35.67% and motility index ˂ 5.1. Anthropometric measurements, plasma glucose, glycosylated hemoglobin (HbA1c), lipids profile, vitamin B12 and transabdominal ultrasonography were assessed.ResultsThe frequency of vitamin B12 deficiency in total patients with T2D was 35% (54.5% in patients with gastroparesis vs. 11.1% in patients without gastroparesis, P < 0. 001). Vitamin B12 level was negatively correlated with GCSI Score whereas, it was positively correlated with gastric emptying and motility index. Vitamin B12 deficiency was an independent predictor for gastroparesis in patients with T2D; it predicts gastroparesis at a cut off value of 189.5 pmol/L with 69.1% sensitivity and 64.4% specificity, P = 0.002.ConclusionsBeside the known risk factors of diabetic gastroparesis, vitamin B12 deficiency is an independent predictor of diabetic gastroparesis in patients with T2D.

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

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. 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. 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.

Screening for Gastric Sensory Motor Abnormalities in Pediatric Patients With Type 1 Diabetes

ObjectiveTo determine the frequency of gastric sensory motor symptoms in youth with type 1 diabetes. MethodsA prospective cross-sectional study was performed to evaluate symptoms of delayed gastric emptying in participants with type 1 diabetes, aged 12 to 25 years, using the Gastroparesis Cardinal Symptom Index (GCSI) questionnaire. In addition, a 5-year (January 2015 to December 2019), a retrospective study was completed on all gastric emptying scans performed in youth at our institution. ResultsA total of 359 participants (mean age, 17.7 ± 3.33 years) with type 1 diabetes completed the GCSI questionnaire. Compared with nonresponders, responders were more likely to be non-Hispanic White (90% vs 86%; P =.003) and female patients (58% vs 44%; P <.0001), with a lower HbA1c (8.1 ± 1.8 vs 9.0 ± 2.1; P <.0001). At least 1 gastrointestinal symptom was reported in 270 (75%) of responders, of which nausea was the most common (71%). A GCSI score of ≥1.9 suggestive of more severe gastrointestinal symptoms was reported in 17% of responders. Participants with scores ≥1.9 were older (19.1 ± 3.0 vs 17.8 ± 3.3 years; P =.01). In the retrospective study, 778 underwent gastric emptying scan, 29 participants had type 1 diabetes and 11 (38%) showed delayed gastric emptying. ConclusionGastrointestinal symptoms related to gastric sensory motor abnormalities are seen in youth and young adults with type 1 diabetes. In particular, for those with higher GCSI scores, earlier recognition and referral may be warranted.

S1089 Minimal Clinically Important Differences in Overall and Individual Gastroparesis Symptoms After G-POEM: Impact of Clinical Factors and Prior Treatments

Introduction: Gastric peroral endoscopic myotomy (G-POEM) reduces symptoms in gastroparesis to varying degrees. Studies using Gastroparesis Cardinal Symptom Index (GCSI) surveys set cutoffs for minimal clinically important differences (MCID) that reflect significant longitudinal improvement over time. Few studies have assessed MCIDs of individual gastroparesis symptoms after G-POEM or impact of clinical factors on MCID responses. We compared MCIDs to G-POEM for overall and individual symptoms relating to gastric emptying, pain and opioid use, conditions associated with gastroparesis, and prior therapy. Methods: 22 refractory gastroparesis patients completed GCSI surveys (0=no symptoms, 5=very severe) before and 85±64 days after G-POEM from 2017-21. MCIDs >1 after G-POEM were deemed significant for overall GCSI and individual nausea/vomiting (NV), early satiety/fullness (ES), and bloating/distention (BL) scores. Results: 11/22 patients (50%) met MCID cutoffs for significant GCSI decrease after G-POEM. Individual symptom decreases meeting MCID cutoffs were seen in 12 patients for NV and ES (54%) and 9 for BL (41%). NV and ES reductions were greater in those meeting GCSI MCID cutoffs; BL reductions trended higher (Figure). Gastric emptying normalized in 8/20 patients (40%) which was not different in MCID responders vs. nonresponders for GCSI (44 vs. 36%, P=1.0), NV (30 vs. 50%, P=0.65), ES (40 vs. 40%, P=1.0), or BL (56 vs. 27%, P=0.46). Pain as a major symptom was noted by 2/10 responders (20%) vs. 4/11 nonresponders (36%)(P=0.64). Opioids were used by 3/11 responders and 3/11 nonresponders (27%, P=1.0). Higher basal symptoms, associated IBS and fibromyalgia, and therapies (opioids, metoclopramide, botulinum toxin) impacted responses (Table). Conclusion: Important overall symptom responses to G-POEM using MCIDs were reported by half of gastroparesis patients. Individual symptoms of nausea/vomiting and early satiety showed meaningful decreases more often than bloating. MCID responses did not relate to gastric emptying or pain as a major symptom, but opioid use weakly predicted reduced early satiety/fullness. Increased basal gastroparesis symptoms and IBS related to greater response; fibromyalgia weakly predicted lower response. Metoclopramide use predicted response while higher numbers of botulinum toxin injections weakly related to lesser response raising concerns about pyloric scarring. These findings may be considered in selecting patients for G-POEM.Figure 1.: Individual symptom reductions in nausea/vomiting and early satiety/fullness in patients showing MCID responses in overall GCSI to G-POEM were greater than nonresponders. Bloating/distention improvements trended greater. Table 1. - Symptom Score Measuring MCID Response Associated with Improved Response Associated with Poorer Response Factor P Value Factor P Value Overall GCSI score Higher basal individual postprandial fullness score 0.04 Higher number of botulinum toxin injections 0.08 Prior metoclopramide use 0.08 Nausea/vomiting GCSI subscore Higher basal NV GCSI subscore 0.03 Diabetic gastroparesis etiology 0.09 Higher basal individual nausea score 0.02 Fibromyalgia 0.09 Higher basal individual vomiting score 0.03 Early satiety/fullness GCSI subscore Higher basal NV GCSI subscore 0.03 Fibromyalgia 0.06 Higher basal ES GCSI subscore 0.01 Higher basal individual postprandial fullness score 0.001 Prior opioid use 0.06 Prior metoclopramide use 0.01 Bloating/distention GCSI subscore IBS 0.04

S1585 Combining Surgical Pyloroplasty and Gastric Electrical Stimulation in Gastroparetic Patients Is Superior to Pyloroplasty Alone: A Randomized Double Blind Placebo Control Trial

Introduction: Pathophysiology of gastroparesis (GP) is related to the depletion of interstitial cells of Cajal in the stomach and suspected pathology of the pyloric smooth muscle. Pyloroplasty (PP) accelerates gastric emptying (GE), while gastric electrical stimulation (GES) improves GP symptoms. Our double-blind randomized clinical trial investigated if combining surgical PP and GES is more effective than PP alone. Methods: Drug refractory GP patients underwent simultaneous surgical implantation of the GES system with PP. Scintigraphic GE was performed at baseline (all participants were delayed at 4 h with >10 % retention), and 3 months after surgery. Patients were randomized to 3 months of active GES stimulation (ON group with default setting of GES parameters), or no stimulation (OFF group). All patients then had GES turned ON for another 3 months. GP Cardinal Symptom Index (GCSI) with 6-points scale (0- none; 5-very severe) was recorded at baseline, 3 and 6 months after the surgery. Delta changes of GCSI and individual GP symptoms in ON and OFF groups at 3 and 6 months versus their baseline were calculated and compared using 2-way ANOVA followed by Tukey’s post-hoc analysis. Results: 30 GP patients (18F; mean age 46 (21-72); 6 idiopathics; 24 diabetics with mean duration of DM 24 years (3-50); mean duration of GP 5.6 (1-18) years met criteria for the trial. The mean baseline 4 h GE retention was not different in GES-OFF and -ON group. GE was significantly accelerated at 3 months in GES-OFF (46%) and GES-ON (62%) groups (*P< 0.05), and 39% patients normalized their 4h GE. Patients were randomized to GES-OFF or ON (15 patients per group). GP etiologies were similar in both groups. Baseline GCSI in GES-OFF (3.5±0.2) was comparable to GES-ON (3.7±0.2) group, and significantly improved in 3 months compared to baseline (P< 0.01) in both groups. However, mean GCSI score was significantly better (P< 0.05) in GES-ON than GES-OFF group (Figure). When GES was turned ON in GES-OFF group at 3 months their GSCI significantly improved at 6 months. The frequency of hospitalizations due to vomiting was significantly reduced in GES-ON vs OFF group (P=0.02). There were no post-surgical complications or technical dysfunctions recorded during this trial. Conclusion: Our randomized, double-blind study has revealed for the first time that combining GES with pyloroplasty is statistically more effective than PP alone in controlling GP symptoms and GE is similarly accelerated following PP in both groups.Figure 1.: Changes of Gastroparesis Cardinal Symptom Index (GCSI) at 3 and 6 months in GES-ON versus GES-OFF group compared to baseline. **P<0.01

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

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. 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. 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 27min 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). 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.

Roux-en-Y gastric bypass as a salvage solution for severe and refractory gastroparesis in malnourished patients.

Gastroparesis (GP) is a rare condition for which several symptomatic treatments are available, but they may fail, leading to a discussion of gastrectomy. Few studies have described gastric-preserving surgery, particularly in malnourished patients. To describe the treatment of severe refractory GP with Roux-en-Y gastric bypass (RYGB). A university center. A retrospective review was conducted of adult patients who underwent laparoscopic RYGB. Severity and frequency of GP symptoms were compared before and 1 year after surgery using the Gastroparesis Cardinal Symptom Index (GCSI) score (0-5), the vomiting (VM) score (0-4), and the visual analog scale (VAS) for abdominal pain. Of the 9 patients with refractory GP, 7 were malnourished and 2 had obesity. There were no postoperative deaths. One patient was operated on for internal hernia without bowel necrosis. The mean GCSI score decreased significantly from 3.6 (range: 1-5) preoperatively to 2.1 (range: .3-4.4) postoperatively (P = .0019). The mean VM score improved significantly after surgery, from .22 (range: 0-1 units) preoperatively to 2.55 (range: 1-4) postoperatively (P = .007). The mean VAS score also decreased significantly from 7.0 (range: 5-9) preoperatively to 2.44 (range: 0-7) postoperatively (P = .0015). A nonsignificant weight and albumin change was observed at 1 year postoperatively, with a tendency for weight regain in malnourished patients. In malnourished patients with severe and refractory GP, this study suggests the feasibility, safety, and efficacy of RYGB for the treatment of vomiting and abdominal pain.

Gastric peroral endoscopic myotomy outcomes after 4 years of follow-up in a large cohort of patients with refractory gastroparesis (with video)

Gastric peroral endoscopic myotomy (G-POEM) is used for refractory gastroparesis (RG) with good early-term but variable mid- and long-term outcomes. Limited data exist about candidates and long-term clinical and predictive factors. Our aim was to evaluate the 4-year follow-up efficacy and predictive factors in patients with RG. Confirmed RG patients were included and evaluated between April 2017 and December 2021. Gastroparesis Cardinal Symptom Index (GCSI) score, retention percentage at 4 hours (RP4H), mean half-emptying time (MHET), and the 36-item short-form survey (SF-36) were performed at 1, 6, 12, 18, 24, 30, 36, 42, and 48 months. After G-POEM, 374 patients with RG were included: 141 patients (37.7%) had diabetic gastroparesis (DG), 115 (30.7%) had idiopathic gastroparesis (IG), 102 (27.3%) had postsurgical gastroparesis (PSG), and 16 (4.3%) had other etiologies. After the 48-month evaluation, 102 patients completed follow-up (DG, 58; IG, 22; PSG, 18; other, 4). Before G-POEM, GCSI score, RP4H, and MHET were 3.84 ± .53, 44% (interquartile range [IQR], 11-68), and 246 minutes (IQR, 150-368), respectively, and after the 48-month evaluation improved to 2.1 ± .70 (P< .001), 15.5% (IQR, 0-36; P= .021), and 135 minutes (IQR, 67-290; P= .045), respectively. At the 48-month evaluation, clinical success was 77.5%. DG showed the best outcomes (DG vs IG vs PSG vs other: 86.5% vs 72.5% [P= .001] vs 72.1% [P= .003] vs 68.8% [P< .001]). Long-term success predictors were DG (odds ratio [OR], 5.113; 95% confidence interval [CI], 1.643-5.981; P= .035), early diagnosis (OR, 2.455; 95% CI, 1.129-3.522; P= .042), nausea/vomiting (OR, 3.541; 95% CI, 1.881-5.511; P= .012), GCSI score at 6 months (1.5-2) (OR, 3.612; 95% CI, 2.122-5.317; P= .022), and RP4H<10% at 6 months (OR, 2.188; 95% CI, 1.435-4.233; P= .039). G-POEM is an effective 4-year treatment in patients with RG, especially in DG, establishing a potential first-line therapy in these patients. However, randomized controlled clinical trials are needed to confirm these results. (Clinical trial registration number: NTC03126513.).