MANAGEMENT OF PATIENTS AFTER FAILED GASTRIC PERORAL ENDOSCOPIC MYOTOMY (G-POEM): A MULTICENTER STUDY

Background:
Endoscopic ultrasound-guided gastroejejunostomy (EUS-GJ) has gained popularity in treating malignant gastric outlet obstruction (GOO). EUS-GJ has also been used to manage benign GOO with promising technical and clinical success. The long-term efficacy and course of EUS-GJ in benign GOO are important to understand given the longer treatment course entailed, compared to malignant GOO in which end of life may be eminent. The aim of this study was to determine efficacy and clinical course of EUS-GJ in benign GOO.
Methods:
This was a single center retrospective series. Consecutive patients who underwent EUS-GJ from January 2017 to May 2022 for treatment of benign GOO were included. The primary outcomes were technical and clinical success. The secondary outcomes included prior endoscopic treatment, adverse events, and follow-up (clinical and endoscopic).
Results:
A total of 16 patients (43.75% female; mean age 63.3 +/- 14.8 years) underwent EUS-GJ for benign GOO. The etiology of the patients’ respective GOO’s was intrinsic in 50% of patients (8/16) and extrinsic in 50% of patients (8/16). These included pancreatitis (n=5), NSAID induced stricture (n=4), peptic ulcer disease (n=2), and SMA syndrome (n=2) among others. Technical success was achieved in 100% (16/16) patients and clinical success was achieved in 93% (15/16) patients- one patient required stent exchange due to occlusion in the first month. Hot Axios^TM stent was used; 20 mm x 10 mm in 12 patients and 15 x 10 mm in 4 patients. Stents remained in place for an average of 329 days and 25% of patients (4/16) had their stents removed on follow-up. In total, 13 patients had follow-up endoscopy, 1 patient was lost to follow-up, and 2 patients died of other chronic illnesses. On endoscopic follow-up, the stent was patent in all patients with no evidence of tissue overgrowth. On follow-up, 10 patients had normal jejunal mucosa at an average of 5.9 months from EUS-GJ, 1 patient had jejunal erosions 6-months after the procedure, and 2 patients had ulcerations at an average of 6.5 months from the procedure.
Discussion:
This series adds to very limited literature on EUS-GJ for benign GOO, showing that it is both technically feasible and clinically beneficial. This study uniquely features follow-up at up to 1444 days from EUS-GJ. In the 4 of 16 patients whose stents were removed during the study, 75% of patients (3/4) had an extrinsic etiology, which was consistent with expectations given that extrinsic causes of GOO are more likely to resolve. No patients had stent damage or tissue overgrowth and most patients had normal jejunal mucosa on follow-up. Limitations of this study include the single center retrospective nature and the small sample size. A larger and prospective data set is needed to further describe the clinical course of EUS-GJ for benign GOO.

Endoscopic resection (ER) is the standard technique for the treatment of duodenal adenomas (DA). However, it can be technically challenging in flat lesions or lead to bleeding or perforation. A small retrospective study found that cryoballoon ablation (CBA) led to complete eradication (CE) of DA with no adverse events. AIM: To assess the safety and efficacy of nitrous oxide focal CBA in a prospective multicenter clinical trial (NCT03847636). METHODS: We enrolled patients with or without familial adenomatous polyposis (FAP) with benign non-ampullary DAs in the first or second portion with maximum diameter 1-5 cm, thickness <=4 mm (Paris 2a, 2b,1s) involving < 50% circumference and < 3 duodenal folds, no prior ablation or surgery. Prior EMR >6 weeks from CBA allowed. We excluded Paris 1p, 0-2c, 0-3 or malignant DAs. Using a cryogen dose of 8-12 seconds, we treated DA (up to 5 per procedure) at baseline and every 3 months until CE, maximum of 5 treatments in 1 year. Follow-up continued to minimum of 1 year. Primary endpoints: clinical response (>=50% eradication of treated DA using endoscopy and/or pathology), and change in Spigelman class (FAP only). Secondary endpoints: percent eradication, safety, technical success, procedure time. A 3-member expert panel blindly reviewed FAP images and videos and independently scored post-CBA response (+1 clinical improvement, 0 no improvement, -1 increase in DA size and number). RESULTS: To date, 28 patients enrolled, 19 (68%) completed treatment for 48 DAs, in a median of 2 procedures, within 4 min/DA (Tables 1a,1b). 6(21%) had prior EMR. Technical success was 86% (minor device malfunction or difficulty in positioning in 4 FAP patients). There were no serious adverse events; 4 patients had mild immediate transient post-procedure discomfort not requiring treatment. In 19 evaluable patients, we noted clinical response in 95%, with 90% complete, 5% partial (>=50% size reduction), and 5% minimal/no eradication (<50% size reduction) (Figure 1a). A median of 4 CBA procedures (IQR1-5) were needed to achieve CE. Median time for CBA per session was 4 minutes (IQR 2.2-7.8). The Paris classification of 48 of eligible treated polyps was 1s (13%), 0-2a (69%),0-2b (12%) or mixed (6%),with median diameter of 20 mm (IQR 15-30) (Table 1b).To date, in 38 of 48 polyps that completed treatment, we noted 26(74%) complete and 7(20%) partial eradication, with median decrease in DA size of 17 mm (IQR10-20) (Table1b). In all treated polyps, a clinical response was noted in 95% (Figures 1b, 2a-d). In FAP patients, blinded review showed improvement in polyp size and number in 4/4 and downgraded Spigelman class in 2/4 (Stage 3 to 2, Stage 3 to1). CONCLUSION: CBA is a safe, efficient, and effective therapy for DAs. Our preliminary results suggest it is a potential alternative therapy for select non-polypoid or thin sessile non-ampullary DA.

Introduction:
Gastric per-oral endoscopic myotomy (POP or GPOEM) is an endoscopic procedure aimed at reducing symptom burden in patients who suffer from refractory gastroparesis. Despite publications describing improved symptom response after GPOEM, there is a subset of patients who fail to respond to initial GPOEM or develop a recurrence of symptoms. There are only two case reports that describe clinical outcomes after redo GPOEM for patients who have had a recurrence of gastroparesis. We report the clinical and procedural outcomes of nine patients undergoing redo GPOEM at a single center for patients who have failed or developed recurrent symptoms after index GPOEM.
Methods:
We performed a retrospective study of patients who underwent index GPOEM and redo GPOEM between October 2016 and March 2022. Patients who were included had demonstrated delayed gastric emptying on scintography and clinical symptoms consistent with gastroparesis refractory to medical treatment. Various demographic, disease-related and procedure-related data were collected from chart review. Symptom severity was determined by patient-reported symptoms calculated by the Gastroparesis Cardinal Symptom Index (GCSI). Clinical success of redo GPOEM was defined as a decrease of at least 1 point in mean GCSI and a 25% decrease in at least 2 subsets of cardinal symptoms. Statistical analysis was done using paired t test where appropriate.
Results:
Nine patients (mean age 43.6, range 26- 68, 100% female) were included in this study. All nine patients had failed medical therapy prior to initial intervention. Additionally, one patient failed implantation of neurostimulator prior to undergoing index GPOEM. Four patients (44.4%) had diabetic gastroparesis, two patients (22.2%) had post-surgical gastroparesis, and three patients (33.3%) had idiopathic gastroparesis. Technical success was achieved in 100% of both index and redo GPOEMs. There was no significant difference in procedural times, number of clips, or length of myotomy between index GPOEM and redo GPOEM (table 1). Figure 1 describes the trend of GCSI assessed prior to and post index and redo intervention. Clinical success was achieved in five patients (55.6%). Eight patients (88.9%) experienced improvement in their gastroparesis symptoms. There were no adverse events.
Discussion:
Redo GPOEM is a safe and feasible option to offer as a salvage therapy for patients with recurrent symptoms of gastroparesis. Further studies with a larger population are needed to distinguish which patients would most benefit from this procedure.

Introduction:
Gastric peroral endoscopic myotomy (G-POEM) is an innovative procedure that seeks to improve clinical outcomes for patients suffering with refractory gastroparesis. Treating gastroparesis is often a challenging experience for both patients and clinicians, and oftentimes does not lead to a significant improvement of symptoms. G-POEM has emerged as a procedure with a potential to serve as a sustainable and highly tolerable solution for gastroparesis, yet there is a paucity of documented long-term outcomes of those who undergo the procedure. We aimed to perform a systematic review and meta-analysis of studies examining G-POEM utilization for gastroparesis and its long-term outcomes.
Methods:
We performed a comprehensive and systematic search across multiple electronic databases since inception until November 2022 to identify studies reporting the long-term outcomes (≥1 year follow up) of G-POEM in treatment of refractory gastroparesis. The pooled weighted rates of technical success, adverse events and clinical success were calculated based on random effects model. The clinical success rates reported by the studies based on gastroparesis cardinal symptom index (GCSI) score were pooled and outcomes were evaluated as pooled clinical success rates at 1 year, 1-2 years and at 3 years based on study follow up durations. I² statistics were used to analyze heterogeneity.

Results:
We identified 12 studies with a total of 871 patients that evaluated long term outcomes of G-POEM for gastroparesis management. The weighted, pooled rates of technical success rate of performing G-POEM in patients with refractory gastroparesis was 98.7% (95%CI: 97.1 – 99.4; I² = 0). The pooled rate of adverse events was found to be 8% (95% CI: 5.2 – 12.0; I² = 45.35). The weighted pooled clinical success rates at 1 year, 1-2 years and 3 years follow up was found to be 70.9% (95% CI: 57.7 – 81.2; I² = 79.7), 72.3% (95%CI: 57.5 – 83.4, I² = 67.0) and 74.2% (95% CI: 63.9 – 82.5; I² = 45.88) respectively. Heterogeneity was minimal to high in our analyses.
Conclusions:
Our study shows that G-POEM is a safe and effective procedure in the management of refractory gastroparesis. Furthermore, our study also shows that G-POEM achieved a sustained clinical response until 3 years after the procedure. Further long-term prospective studies are required to validate our results.

Introduction: Previous studies reported that the non-balloon percutaneous endoscopic gastrostomy (PEG) tube had a longer lifespan than the balloon tube. Therefore, it is recommended that the balloon type needs a sooner replacement (3-6 months vs. 6-12 months). To date, there has been no experimental study on complication-pattern differences. Therefore, we conducted a randomized trial to compare the tube lifespan and complication rates/patterns at 6-12 months after PEG replacement by the two tubes.
Method: Patients who underwent PEG tube exchange from 1/2021 to 10/2021 were randomly assigned to receive either a 20 Fr. balloon or non-balloon replacement tube. The water irrigation test was used to ensure tube position. EGD was performed whenever the tip confirmation was in doubt. Patients were instructed for another replacement at 6-12 months. Data were collected longitudinally from the exchange date until the development of the desired event, death, or the end of the study. The primary outcome was major complications classified as tube occlusion or other complications requiring replacement (tube dislodgement, buried bumper syndrome (BBS)), and the secondary outcome was complications not requiring replacement (peri-ostomy cellulitis and excessive granulation tissue growth). Baseline characteristics and time to first replacement were compared between groups using the Kaplan-Meier and Cox-regression methods.
Result: 87 patients (48% male) with a mean age of 74 ± 23 years were included. 45 patients were randomized to the balloon group, and 42 were to the non-balloon group. All patients completed the study. Dysphagia from neurological disorder was the most common indication (n=86; 99%). There were no statistical differences in baseline characteristics regarding gender, co-morbidities, and feeding formula between groups. The overall complication rate and major complication rate were comparable between the balloon and non-balloon groups (46.7% vs. 45.2%; p=0.79, and 35.6% vs. 28.6%; p=0.61, respectively), with the median tube lifespan of 173 and 214 days, respectively (Table1 and Figure1). At 12 months, BBS developed only in the non-balloon group (9.5% vs. 0%; p<0.05), whereas more tube dislodgement was found in the balloon group (18.4% vs. 9.5%; p<0.05). EGD facilitating tube replacement was significantly higher in non-balloon group (16.7% vs. 0%; p<0.05). No differences in minor complications were observed, including excessive granulation tissue growth (4.4% vs. 4.8%; p=0.94) and peristomal cellulitis (6.7% vs. 11.9%; p=0.39).
Conclusions: Approximately 80% of both PEG replacement types could last 6 months. EGD-guided PEG exchange was required more in non-balloon type. Despite comparable complication rates, the pattern of major complication differed; tube dislodgement was seen more often in the balloon type, whereas BBS was more common in non-balloon PEG.

Introduction:
Endoscopic sleeve gastroplasty (ESG) is a safe and effective treatment for obesity which involves full-thickness suturing to reduce gastric volume. As optimal suture technique and tension are not yet fully understood, a new, promising technology could potentially allow for real-time optimization of the procedure via the endoscopic change in mucosal oxygen saturation (StO2) through multi-wavelength emission and spectral analysis of reflected light. We report StO2 levels pre and post primary intervention ESG in an effort to create a foundation for further investigation.

Methods:
This is a retrospective study of all patients who underwent StO2 imaging prior to and immediately after primary intervention ESG from September 2021 to October 2022 in a bariatric endoscopy clinic. Patients with gastrointestinal pathology or prior surgeries were excluded. A computer processor that is compatible with commercially available endoscopes was used to curate pseudo-color-based scale images which were then used to precisely quantify mucosal StO2 levels through a dedicated software. Clinical and demographic information were also collected.

Results:
A total of 9 patients were included. All patients were females with a mean age of 46 (± 8). The mean pre-ESG BMI was 35.1 (± 4.8) and post-ESG nadir BMI was 28.8 (± 2.7) with an average %Total Weight Loss (%TWL) of 16.5% (± 6.2%). 7 patients underwent plication while 2 patients underwent suturing ESG. The average post-procedural StO2 of the gastric body was 37% (± 26%) which was significantly less than the pre-ESG mucosal StO2 levels 75% (± 13%) (p<0.05).

Conclusion:
Our results show that ESG significantly decreases mucosal StO2 in the gastric body. By measuring real-time StO2 changes during ESG using this new endoscopic technology, this could potentially lead to enhanced procedural optimization and ultimately improved patient outcomes. Further investigation is needed to better understand the role of mucosal oxygen saturation measurement in ESG techniques.

Background: The heterogeneous clinical outcomes of gastric peroral endoscopic myotomy (G-POEM) in patients with refractory gastroparesis is an important shortcoming of the procedure. The optimal management of patients who fail G-POEM is not known. We aimed to compare the outcomes of different management strategies in patients who had failed G-POEM. Methods: This was a multicenter retrospective study at 7 tertiary centers between 02/2020 and 10/2022. All patients who underwent G-POEM and experienced persistent (primary) or recurrent (secondary) symptoms were included. The primary outcome was clinical success after additional treatment, defined as having at least one-score decrease in average Gastroparesis Cardinal Symptom Index (GCSI) with a ≥ 25% decrease in at least 2 sub-scales post-G-POEM. Results: A total of 233 patients [mean age 47.8 ± 15.6, F 170 (73%)] underwent G-POEM for the management of refractory gastroparesis at 7 U.S. tertiary care centers and 92 (39%) patients experienced clinical failure with a median GCSI score of 2.4 (IQR 2.1-3.3). The majority, 86 (93%), were primary clinical failures. Diagnosis of secondary clinical failure occurred at a median time of 3.9 (1.5-3.6) months post-G-POEM. Post-G-POEM GES was performed in 35 (38%) [abnormal in 14 (40%)], and diagnostic upper endoscopy in 57 (62%) [findings suggestive of gastroparesis 35 (83%)] patients. During the duration of the study, a total of 25 (27%) underwent re-treatment (balloon dilation 7, gastric neurostimulator (GNS) 6, surgical pyloromyotomy 2, botulinum toxin injection 4, repeat G-POEM 6), while 67 (73%) underwent pharmacologic and/or symptomatic interventions (percutaneous feeding tube placement 11, transpyloric stenting 1, celiac block 8, pharmacologic 47) (Table 1). Among the patients who underwent re-treatment, clinical success was achieved in 12 (46%) patients during a median duration follow-up of 9.4 (IQR 6-13) months, with a decrease in the median GCSI score from 2.8 ± 1.6 to 1.5 ± 1.8, (p=0.024). A total of 9 patients in the re-treatment group underwent both pre- and post-retreatment GES with an improvement in gastric retention at 4 hrs. from 38 ± 20.83 % to 23 ± 19.7 %, (p=0.124). The highest clinical success was achieved among patients with GNS, 5 (83%), followed by repeat G-POEM, 4 (67%) (Figure 1). Having an abnormal GES post-G-POEM was found to be the only independent predicting factor (OR 1.6, p=0.031) for clinical success post-re-treatment. Concomitant gastrointestinal pathologies were noted in 6 (6.5%) (esophageal dysmotility treatment 2, sphincter of Oddi dysfunction 1, candida esophagitis 3). Conclusion: Our study highlights that further treatment strategies may still be considered in this refractory patient population, particularly for patients with abnormal GES post-failed G-POEM, and that concomitant pathologies should always be ruled out.