Introduction

Gastroparesis (GP) is a poorly understood condition with current diagnostic tests lacking disease specificity. Gastric per oral endoscopic myotomy (G-POEM) has emerged as a promising treatment for refractory gastroparesis, however up to a third of patients fail to have an improvement in their symptoms.

Aims & Methods

We assessed the ability of Gastric Alimetry®, a new, non-invasive test of gastroduodenal function to enhance patient selection for G-POEM. Data was collected from patients with suspected GP (based on symptoms and scintigraphy), being worked up for G-POEM at Kings College Hospital between November 2022 and September 2023 (REC: 22/LO/0802). G-POEM success was defined as <1 point reduction in GCSI score. Descriptive comparisons were used to explore predictors of improvements in gastroparesis cardinal symptom index (GCSI).

Results

11 patients were assessed (8F, median age 40 interquartile range 32.5-49.5). GCSI scores significantly improved after G-POEM (median difference -1.03, IQR 0.50). Aetiologies of gastroparesis included 5 (45.5%) diabetic, 4 (36.4%) idiopathic, and 2 other aetiologies. Gastric Alimetry spectral analysis showed 2 (18.2%) with high frequencies, 2 (18.2%) with neuromuscular dysfunction (low rhythm stability and/or low amplitude), and 7 (63.6%) with normal spectral metrics. Symptom profiles followed a continuous pattern in 4 (36.4%), sensorimotor in 2 (18.2%), post-gastric in 1 (9.1%) and meal-induced in the remainder (36.4%). High frequency phenotype was associated with treatment failure (2/2, 100%), and neuromuscular phenotype was associated with success (2/2, 100%). The change in GCSI score after G-POEM was significantly lower in the high frequency group compared to the group average (median difference -0.18, IQR 0.18; p = 0.03).The average frequency and rhythm index was 2.9 (0.1) cycles per minute (cpm) and 0.4 (0.2) respectively among responders vs 3.2 (0.4) cpm 0.6 among non-responders.

Conclusion

Gastric Alimetry® is a new, non-invasive test of gastric function with provisional utility in differentiating disease mechanisms in patients with suspected GP. Early data suggests biomarkers for gastric autonomic dysregulation (high slow wave frequencies) were associated with reduced response to G-POEM. Further data are eagerly anticipated to validate these findings and develop more sophisticated predictive models for G-POEM outcomes.

Introduction

Gastroparesis is a heterogeneous condition lacking in actionable biomarkers with which to guide treatments. Gastric per oral endoscopic myotomy (G-POEM) has emerged as a promising treatment for refractory gastroparesis, however as many as half of patients can fail to benefit.

Aims & Methods

We assessed the ability of body surface gastric mapping (BSGM) using Gastric Alimetry®, a non-invasive test of gastric function to enhance patient selection for G-POEM. Patients with suspected gastroparesis at Kings College Hospital were recruited (Nov 2022 - Sep 2024). BSGM included 30 m fasting, standard nutrient drink + oatmeal bar (482 kcal), and 4 h postprandial recording. BSGM phenotyping followed an established classification scheme. G-POEM success was defined as <1 point reduction in gastroparesis cardinal symptom index (GCSI) with sensitivity analysis using >50% GCSI improvement. Mixed models accounted for repeated measures.

Results

22 patients completed initial follow-up (median 3.3 months; 77% female; median age 35.5; IQR 21-76). Gastroparesis aetiologies included 9 (41%) diabetic, 12 (55%) idiopathic, and 1 post-surgical. BSGM spectral analysis showed 4 (18.2%) with high frequencies, 3 (13.6%) with neuromuscular dysfunction (low rhythm stability and/or low amplitude), and the remainder had normal spectral metrics (n=15; 68.2%). Symptom profiles had a continuous pattern in 8 (36.4%), meal responsive pattern in 14 (59.1%; of whom 6 had sensorimotor correlation), and a 1 (4%) with a post-gastric pattern. GCSI scores significantly improved after G-POEM (median -0.92; IQR -1.8 to -0.34, p=0.0001) with 11 (50%) experiencing at least a 1 point GCSI reduction, and 7 (31.8%) experiencing >50% GCSI score reduction. Neuromuscular phenotype was associated with treatment success (27.3% vs 0%; and 28.6% vs 6.7% in sensitivity analysis), in keeping with responders having a lower BMI-adjusted amplitude (median 30.3 [IQR 23.1-41.0] vs median 45 [36.5-53.4]; p=0.03). Conversely, the high frequency phenotype was associated with treatment failure (9.1% vs 27.3%; and 0% vs 26.7% in sensitivity analysis). Elevated gastric frequency with comorbid diabetes was associated with higher post-G-POEM GCSI (β = 1.61, 95% CI 0.08 - 3.13, p=0.04) and a lower GCSI change (median -0.3 vs overall GCSI improvement -0.9, p=0.005).

Conclusion

At initial analysis of this ongoing clinical study, Gastric Alimetry demonstrates provisional utility in predicting GPOEM success based on underlying disease mechanisms in patients with refractory gastroparesis. First data suggests biomarkers for diabetic vagal dysregulation (high frequencies) were associated with reduced response to G-POEM, while patients with gastric neuromuscular dysfunction showed clearest benefit. Additional recruitment is ongoing to validate these findings.

Introduction

Gastric Per-oral Endoscopic Myotomy (G-POEM) has been proposed as a new treatment modality for patients with gastroparesis and is considered to be effective in two out three patients. Most studies focus on post procedural data of gastric retention during gastric emptying study and patient oriented self-reported scoring system as Gastroparesis Cardinal Symptom Index (GCSI) in order to measure G-POEM effectiveness.

Aims & Methods

We aimed to evaluate the effectiveness of G-POEM focusing on clinical post procedural evidence: hospitalisation rate, nasojejunal feeding tube and medication use. We analysed retrospectively data from consecutive patients undergoing G- POEM from 09/2018 to 2/2023 in our department. Epidemiological, laboratory and clinical pre-procedural and post-procedural data as also data about adverse events during and after the procedure were collected.

Results

In total 45 patients (M/F: 14/31, mean age: 36±12 years) were included, with mean follow up of 23±17 months. Gastroparesis etiology was: diabetic/idiopathic/Ehlers-Danlos syndrome/other: 23/16/5/1 with mean disease duration 6.7±5.6 years. Pre-procedural mean gastric retention (%) at 1 hour was 71.8±28.6. Two patients had gastric electrical stimulation devices in situ, while 14/45 (31.1%) reported previous Botox injection. Baseline prokinetic (metoclopramide/domperidone/erythromycin) use was reported among 35/39 (89.7%), anti-emetics (ondasendron, cyclizine) in 21/39 (53.8%) and 9/39 (23.1%) patients were using prucalopride. Nasojejunal feeding tube was placed in 10/45 (22.2%) patients. At least one hospitalization was documented in 24/38 (63.2%) patients. The mean number of hospital admissions was 4.3±9.1. After G-POEM rate of prokinetics (13/38, 34.2%, p=<0.001), anti-emetic (0/38, 0%, p<0.001) and prucalopride use (10.5%, p=0.224) was reduced. Moreover NJ tube was placed in only 1 patient, rate also significantly reduced (1/45, 2.2%, p=0.007). Additionally the rate of patient admitted at least for one time in the hospital post G-POEM was also significantly reduced (23/33, 36.4% vs 24/38, 63.2%, p=0.033). Post procedural admission rates (at least one hospital admission after G-POEM) did not differ among patients with diabetic or idiopathic gastroparesis (diabetic: 7/17 (41.2%) vs 5/12 (41.7%), p=1.000). No differences were noted also as far as prokinetics (6/16, 37.5% vs 4/17, 37.4%, p=1.000) and prucalopride (2/16, 12.5% vs 2/11, 18.2%, p=0.897). The mean hospital stay after the procedure was 1.05±1.11 days. Perforation during G-POEM was observed in 5/45 (11.1%) patients while significant bleeding was reported in 3/45 (6.6%). All adverse event with the exception of one perforation were managed endoscopically. One patient died during hospitalization though not directly due to procedural adverse event.

Conclusion

Our study points out that G-POEM benefits significantly patients with gastroparesis as it reduces both post-procedural hospitalization rates, need for nasojejunal feeding tube use as also medication use, independently of disease etiology. Procedural complications may develop though the vast majority are managed endoscopically.

Clinical Case Summary

Introduction: While endoscopic retrieval of gastric bezoars has been described involving various instruments and adjuncts, there is no consensus about the management of large non-obstructing gastric trichobezoars¹. This case report describes how a novel endoscopic device primarily developed to resect recurrent or scarred gastrointestinal lesions or pancreatic necrosis, was used to safely remove a large gastric trichobezoar after unsuccessful attempts with standard endoscopic adjuncts.
Case report: A 19-year-old female presented to our ED with CT-proven trichobezoar within the gastric lumen, measuring 123 x 51 mm (image 1).
An initial attempt at endoscopic removal was performed under general anaesthesia. Despite the use of multiple standard instruments (hot and cold snares, biopsy forceps, argon plasma coagulation, and endoscopic scissors) the congealed trichobezoar could not be sufficiently fragmented for removal.
A decision was made to repeat the procedure using EndoRotor™ (Interscope Inc, Whitinsville, Massachusetts), an endoscopic ‘morcellator’ device (image 2), which we have used to safely resect large or scarred, recurrent colorectal and duodenal polyps². The device allowed us to make dents in the trichobezoar, which facilitated the use of hot snares for complete fragmentation and retrieval via Roth net. Our novel use of this for trichobezoar removal was assisted by a team from EndoRotor.
Conclusion: We report the use of this new endoscopic technique to remove a large trichobezoar, which would otherwise have had to been removed surgically. Apart from reduced therapeutic morbidity, this approach facilitated a shorter hospital stay and quicker return to normal activity for our patient, compared to surgical intervention.

References

1. Gorter, R. R., Kneepkens, C. M. F., Mattens, E. C. J. L., Aronson, D. C., & Heij, H. A. (2010). Management of trichobezoar: Case report and literature review. In Pediatric Surgery International (Vol. 26, Issue 5, pp. 457–463). https://doi.org/10.1007/s00383-010-2570-0
2. Emmanuel A, Williams S, Gulati S, Ortenzi M, Gunasingam N, Burt M, Ratcliff S, Hayee B, Haji A. Incidence of microscopic residual adenoma after complete wide-field endoscopic resection of large colorectal lesions: evidence for a mechanism of recurrence, Gastrointestinal Endoscopy, (Volume 94, Issue 2, 2021, Pages 368-375). https://doi.org/10.1016/j.gie.2021.02.010.

Introduction

Gastroparesis (GP) is defined as symptomatic delayed gastric emptying. The most frequent etiologies are diabetes mellitus, after esophageal or gastric surgery and about a third of patients have idiopathic GP. The gastric emptying study by using a scintigraphy scintigraphy (GES) is considered as a principal diagnostic method. Endoscopic pyloromyotomy (G-POEM) is a method improving symptoms in about 60-70% of patients with GP. Its effect on gastric emptying remains controversial.

Aims & Methods

We performed a retrospective single-center analysis to assess the clinical efficicacy of G-POEM based on GES parameters. Between 2016 – 2024, a total of 72 patients with GP (confirmed by scintigraphy) underwent G-POEM and were later invited for clinical as well as scintigraphic assessment after 3, 12 and 36 months. Of these patients, 4 were excluded for missing data, incomplete follow-up data or non-standard testing meal. GES was always performed using the standardized 4 hours protocol with the standard testing meal mixed with 99Tc-DTPA. For this study, all GES were reanalyzed and the following parameters were established : residual activity after 2 hours, residual activity after 4 hours, biological halftimes of ingested activity and proximal-to-distal count ratio for time 0 (PDCR0).

Results

Mean value of GCSI before G-POEM was 3.1 and decreased to 1.6, 1.0 and 0.7 after 3, 12 and 36 months. Median value of GES after 2 hours was 60.2% before G-POEM and 38%, 32.6% and 24.2% after 3, 12 and 36 months. Median value of GES after 4 hours was 21.9% before G-POEM and 7.8%, 6.5% and 3.9% after 3, 12 and 36 months. Correlation index was weakly positive for GCSI and GES after 4 hours only for the first follow-up visit and negative for all remaining visits.
The residual activity after 2 hours and residual activity after 4 hours decreased after G-POEM during all follow-up visits (p<0,001). Mean decrease of residual activity after 4 hours was 12.89%, 15.13% and 6.7% after 3, 12 and 36 months.
Biological halftime also decreased after the procedure with statistically significant results with the mean halftime before G-POEM being 150 min and 86 min, 78.4 min and 65.8 min after 3, 12 and 36 months.
There was a difference between the diabetic and non-diabetic groups, with higher residual activity after 2 hours [median 29.6% before G-POEM, 9.0% after 3 months (p<0.001) and 11.0% after 12 months (p=0.005)] and 4 hours [median 64.8% before G-POEM, 39.4% after 3 months (p<0.001) and 37.7% after 12 months (p=0.012)] respectively in patients with diabetes.
The predictive value of PDCR0 for treatment success after G-POEM was only calculated for the first follow-up visit but was not statistically proved (p=0,712).

Conclusion

In our group of patients there is a weak correlation between the decrease of GCSI and GES early after G-POEM. The decrease in GES parameters tends to be lower in patients with diabetes compared to non-diabetic patients. Based on our data, predicting clinical success of G-POEM using PDCR0 cannot be recommended.

Introduction

There are no agreed guidelines to inform the approach to previously-treated achalasia patients presenting with recurrent symptoms. The decision to proceed to re-intervention is often based mainly on the clinical presentation and data arising from barium swallow studies and upper gastrointestinal endoscopy.

Aims & Methods

We evaluated Endoluminal functional luminal imaging probe (EndoFLIP) and High Resolution Manometry (HRM) value in such a setting. We selected patients from a prospectively-kept database with previously-treated achalasia (including Per Oral Esophageal Myotomy (POEM), Heller myotomy (LHM), pneumatic balloon dilatation (PBD) and botulinum toxin injection (BTX; only if submitted the last six months) presenting with symptom recurrence during an 8-year period (11/2015-2/2023). Only those with assessable EndoFLIP data (distensibility index (DI) at 40ml balloon inflation volume) and planned for re-intervention with POEM according to clinical judgment were included in the study. Baseline data were analyzed retrospectively. Consecutive naïve-to-treatment patients formed the control group.

Results

N=70 patients (25 treated vs 45 naïve) were included in the study (F=38; mean age 43 (17-78yrs). The majority of patients were previously submitted to pneumatic balloon dilatation (n=13), 5 were submitted to POEM A to Heller myotomy and 3 had botox treatment during the last six months before assessment. Table 1 lists the main demographic and investigative parameters. DI of treated patients was significantly decreased among patients without barium clearance at 5 min (1.8±0.9 vs 2.5±1.6, p=0.017) and was correlated to height of barium column (r=-0.439, p=0.015), fact not observed for IRP (29.1±13.5 vs 21.5±8.8, p=0.017 and r=0.266, p=0.319, respectively). DI was not correlated to IRP4s in treated patients (r=-0.168, p=0.374) in comparison to naïve (r=-0.227, p=0.046). Neither DI, IRP, nor barium column at 5 min were correlated to patients Eckardt score among treated patients (p=0.494, p=0.998, p=0.734 respectively).

Conclusion

DI is impaired and correlated to height of barium swallow in 5 minutes in previously treated achalasia patients presenting with symptom recurrence and can be used as an objective metric to tailor re-intervention in conjunction to barium swallow. DI is significantly reduced among treated in comparison to naïve achalasia patients. HRM cannot with certainty navigate treatment decisions in approximately half of treated patients. Future studies that may define specific diagnostic DI cut-offs for patients with recurrence of achalasia symptoms needing re-intervention are needed.

Introduction

Gastric peroral endoscopic myotomy (G-POEM) has proven to be an effective technique for treating refractory gastroparesis^1,2. However, data on the long-term outcomes of the technique remain limited. We present findings from a multicenter study with over one year of follow-up.

Aims & Methods

In this retrospective study, patients undergoing G-POEM for refractory gastroparesis at two Italian centers from March 2019 to October 2024 were included. Primary endpoints were clinical success rates at 1 and 2 years. Secondary endpoints included factors associated with long-term clinical success (CS), changes in Gastric Emptying Study (GES) results, and Body Mass Index (BMI). CS was defined as a ≥1-point improvement in the Gastroparesis Cardinal Symptom Index (GCSI) and a 25% reduction in two symptom subscales.

Results

A total of 56 patients underwent G-POEM (median age 61 years [IQR 25: 45.8 - IQR 75: 71.5], 57.1% female, and 60.8% with idiopathic gastroparesis).
Technical success was achieved in 54 out of 56 cases (96.4%). Only two adverse events were recorded (3.5%, both grade 1 according to the AGREE classification). The median length of myotomy was 3.00 cm (IQR 25: 3.00 - IQR 75: 5.00). Single-layer myotomy was performed in 12 patients (21.4%), while 42 patients (78.6%) underwent full-thickness myotomy.
CS rates were 70.0% (35/50 patients) at 3 months, 66.7% (31/45 patients) at 6 months, 64.9% (24/37 patients) at 12 months, and 57.1% (16/28) at 24 months, with a significant change over time (𝑄=25.36, p<0.001). Among patients with CS at 12 months, 4 experienced symptoms relapse at 24 months, while 1 patient achieved success at 24 months despite not having CS at 12 months. There were no differences in success rates based on the etiology of gastroparesis (Table 1)
In multivariate regression logistic, age (OR = 1.27, p=0.02) and baseline GCSI (OR = 1.45, p=0.03) were significant predictors of CS at 1 year.
Among patients with CS at two years, there was no significant difference between pre-procedure and post-procedure BMI (median follow-up time 1091 days)(22.6 vs 22.0, p=0.40) or between pre- and post-procedure GES t ½ (median follow-up time 901 days)(174 vs 101 min, p=0.078).

Table 1: Clinical success subgroup analysis

Conclusion

The efficacy of G-POEM decreases over time, reaching approximately 60% at two years. Long-term clinical success does not correlate with changes in BMI or GES parameters. Further studies are needed to better understand factors influencing long-term outcomes of G-POEM and to optimize patient selection.

References

1. Mandarino FV, Vespa E, Barchi A, et al. Precision Endoscopy in Peroral Myotomies for Motility Disorders of the Upper Gastrointestinal Tract: Current Insights and Prospective Avenues-A Comprehensive Review. Life (Basel). 2023;13(11):2143. Published 2023 Oct 31. doi:10.3390/life13112143
2. Mandarino FV, Testoni SGG, Barchi A, et al. Gastric emptying study before gastric peroral endoscopic myotomy (G-POEM): can intragastric meal distribution be a predictor of success?. Gut. 2023;72(5):1019-1020. doi:10.1136/gutjnl-2022-327701