Prognostic Value of Pre-Operative Intragastric Meal Distribution in Gastric Emptying Scintigraphy for Long-Term Success of Gastric Peroral Endoscopic Myotomy in Gastroparesis.

BACKGROUND AND AIMS: Gastric emptying scintigraphy (GES) is the gold standard for the diagnosis of gastroparesis. However, data are lacking regarding the prognostic value of pre-operative intragastric meal distribution during GES, in patients undergoing gastric peroral endoscopic myotomy (GPOEM) for gastroparesis. This study investigated the association of GES morphologic parameters and the long-term clinical success of G-POEM. METHODS: This retrospective study included patients who underwent G-POEM for refractory gastroparesis in a tertiary center with preoperative GES data. Intragastric meal distribution was measured using the proximal to distal count ratio (PDCR) at 0, 1, 2 and 4 hours (h), and the retention index (RI) was calculated. Clinical success was defined as a decrease of at least 50% in the post-G-POEM Gastroparesis Cardinal Symptom Index (GCSI) total score. RESULTS: In total, 77 patients were included with a mean follow-up of 40.14 months. Clinical success was observed in 54.55% of patients. The RI was not associated with clinical success. Only PDCR at 0h (PDCR0) was associated with clinical success. In univariate analysis, the median PDCR0 was 6.0 (IQR 5.59) in patients with clinical success and 4.29 (IQR 4.51) in patients with clinical failure (p=0.019). In multivariate analysis, PDCR0 > 5.25 was associated with clinical success (HR = 4.36 [1.55;12.26], p=0.00524). CONCLUSIONS: This study suggests that in patients with gastroparesis, High PDCR0 value (suggestive for a preferential fundic meal distribution) during preoperative GES is associated with long-term clinical response to G-POEM.

American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity.

This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥ 30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.

Digestive neo-epithelialization after endoscopic stenting for upper digestive tract complete disunion.

BACKGROUND: Complete digestive disunion due to anastomotic necrosis is considered a contraindication to endoscopic repair. However, recent publications have suggested that endoscopic treatment by insertion of a self-expandable metal stent (SEMS) is possible. The report of this patient series aims to demonstrate the use of endoscopic management in selected cases with complete digestive disunion. METHODS: Seven consecutive patients with complete and circumferential upper gastrointestinal anastomotic disunion were treated at two European tertiary care centers between 2009 and 2021 by endoscopic insertion of an SEMS. Treatment was performed with a therapeutic gastroscope under general anesthesia, carbon dioxide insufflation, and fluoroscopic guidance, after surgical or percutaneous drainage. RESULTS: All patients were successfully treated by endoscopic insertion of fully or partially covered SEMS left in place for a median of 8 weeks, with a median of 3 endoscopic sessions. Digestive neo-epithelialization was associated with a restored circumferential gut lumen in all cases. The rate of stent migration was 23% and three patients (43%) experienced symptomatic strictures, which were successfully treated by endoscopic dilation. CONCLUSION: Complete digestive rupture could be successfully treated by endoscopy in selected cases, adding proof-of-concept data regarding guided tissue regeneration alongside SEMS placement.

Does the presence of an esophageal motor disorder influence the response to anti-reflux mucosectomy (ARMS) for refractory GERD?

INTRODUCTION: The prevalence of esophageal motor disorders (EMD) in PPI-refractory gastroesophageal reflux disease (GERD) is substantial. However, limited data exist on their impact on the efficacy of endoscopic treatments like anti-reflux mucosectomy (ARMS). This study aimed to evaluate the influence of EMD on ARMS efficacy in patients with PPI-refractory GERD. METHOD: This single-center retrospective study enrolled patients with refractory GERD treated with ARMS-b (anti-reflux mucosectomy band-ligation). High-resolution esophageal manometry (HREM) was conducted before the procedure to identify EMD presence. The primary endpoint was treatment efficacy, defined as >50% improvement in GERD-HRQL score at 1 year. Secondary endpoints included PPI intake, symptom control, ARMS complications, and overall patient satisfaction at 12 months. RESULTS: The study included 65 patients, with 41 (63.1%) showing EMD on HREM. Treatment efficacy was achieved by 33.8% (22) of patients, with 8 without EMD, 11 having isolated LES hypotonia, and 3 with both LES hypotonia and esophageal body motor disorder. No significant differences were observed between patients with and without EMD regarding the primary endpoint, PPI use, symptom control, or complications. Dysphagia developed in 52.3% (34) within 6 months, leading to esophageal dilatation in 15.3% (10). Two patients experienced acute hemorrhage, and one had perforation. CONCLUSION: The presence of esophageal motor disorders does not seem to impact ARMS response, suggesting the technique's consideration in this population. Larger studies are essential for confirming these results and exploring treatment response and post-operative predictors.

Mid-gastric peroral endoscopic myotomy in the treatment of post-sleeve gastrectomy gastric tube twist: Four cases.

Background and study aims Laparoscopic sleeve gastrectomy (LSG) may lead to symptomatic mid-gastric twist in 0.1% to 4% of cases. Endoscopic balloon dilatation often fails, requiring a switch to Roux-en-Y bypass. Submucosal endoscopic treatment is expanding, so we propose a new technique of fibrosis incision after tunnelization, called medio-gastric peroral endoscopic myotomy (MG-POEM). Patients and methods Four patients aged 41 to 70 years underwent MG-POEM in 2020 for symptomatic post-LSG medio-gastric twist. The aim was to describe the technique, and document the efficacy, using the Gastric Outlet Obstruction Scoring System (GOOSS) score and a quality-of-life scale (QOLS). The procedures consisted of a POEM with myotomy and fibrosis incision. Results Median preoperative GOOSS and QOLS were 1/3 ([0-3] and 1.75/10 [0-10], respectively. All procedures were technically successful. One patient had immediate postoperative complications, which were treated conservatively. The median follow-up was 18 months. All patients had improved quality of life and food intake, with median postoperative GOOSS and QOLS of 3/3 and 6,5/10 [6-8], respectively. Two patients required additional pneumatic dilatation for scarring strictures. Follow-up endoscopies and esophagograms showed that the twist had disappeared. Conclusions MG-POEM shows promise for safe and effective management of post-LSG mid-gastric twist, despite requiring a high level of endoscopic skill to perform submucosal tunneling.

Gastric volumetry for the assessment of fundic compliance and visceral hypersensitivity in patients with gastroparesis: a retrospective comparative study.

BACKGROUND/AIMS: The evaluation of visceral hypersensitivity and gastric accommodation in patients with gastroparesis (GP) is difficult. CT-scan gastric volumetry allows to test the distension of different regions of the stomach. We aimed to study gastric volumes and patient's sensitivity to gastric distension between in patients with GP compared to patients with GERD. METHOD: Retrospective study including patients who had CT-scan volumetry for GP or GERD. Two CT-scan series were made after gastric distension: left lateral decubitus 30° (LLD30) for antrum and right lateral decubitus (RLD) for body. Pain and discomfort were assessed using visual analogue scale (VAS). Gastric volumes were measured for LLD30 and RLD. RESULTS: 13 patients (7 GP and 6 GERD) were included. Mean age was 35.6+/-7.3 years. Median gastric volume in the RLD was lower in GP vs GERD (927+/-208 ml vs. 1115+/-163 ml; p = 0.046) while it was similar for LLD30 (1053+/-228 ml vs. 1054+/-193 ml; p = 0.603). GP patients had significantly more pain and discomfort during the procedure: pain VAS for GP was 6[0-9] versus 0[0-2] for GERD, p = 0.004, discomfort VAS for GP was 7[4-10] versus 4[0-5] for GERD, p = 0.007. 66.7% of GERD patients felt no pain vs. 14.3% in GP, p = 0.053. CONCLUSION: This pilot study suggests that GP could be associated with a reduced gastric volume compared to GERD in RLD after gaseous distension. In contrast, patient self-assessment of pain related to gastric distension was greater int GP patients. A lack of fundus accommodation and visceral hypersensitivity could explain some mechanisms in the genesis of GP symptoms.

Gastroparesis is associated with lower volumes in right lateral decubitus suggesting a lower distensibility of the fundus.Gastric volumetry is more painful in patients with gastroparesis than GERD controls, suggesting visceral hypersensitivity to mechanical distension.

Gastric peroral endoscopic myotomy versus botulinum toxin injection for the treatment of refractory gastroparesis: results of a double-blind randomized controlled study.

INTRODUCTION: Gastric peroral endoscopic myotomy (G-POEM) is a promising technique for treating refractory gastroparesis. We present the first double-blind randomized study comparing the clinical efficacy of G-POEM versus pyloric botulinum toxin injection (BTI). METHODS: This randomized study, conducted in two expert centers, enrolled patients with refractory gastroparesis, medically managed for >6 months and confirmed by gastric emptying scintigraphy (GES), into two groups, G-POEM versus BTI, with follow-up of 1 year. The primary end point was the 3-month clinical efficacy, defined as a >1-point decrease in the mean Gastroparesis Cardinal Symptom Index (GCSI) score. Secondary end points were: 1-year efficacy, GES evolution, adverse events, and quality of life. RESULTS: 40 patients (22 women; mean age 48.1 [SD 17.4]), with mean symptom duration of 5.8 (SD 5.7) years, were randomized. Etiologies included idiopathic (n=18), diabetes (n=11), postoperative (n=6), and mixed (n=4). G-POEM showed a higher 3-month clinical success than BTI (65% vs. 40%, respectively; P=0.10), along with non-significantly higher 1-year clinical success (60% vs. 40%, respectively) on intention-to-treat analysis. The GCSI decreased in both groups at 3 months and 1 year. Only three minor adverse events occurred in the G-POEM group. The GES improvement rate was 72% in the G-POEM group versus 50% in the BTI group (non-significant). CONCLUSION: G-POEM seems to have a higher clinically relevant success rate than BTI, but this was not statistically demonstrated. This study confirms the interest in treatments targeting the pylorus, either mechanically or chemically, for managing refractory gastroparesis.

EUS-guided Gastroenterostomy: A Multicenter International Study Comparing Benign and Malignant Diseases.

BACKGROUND: Endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) is a minimally invasive therapy for patients with gastric outlet obstruction without the risks of surgical bypass and the limited long-term efficacy of enteral self-expanding metal stent placement. However, due to its novelty, there is a lack of significant data comparing long-term outcomes of patients with EUS-GE, based on the underlying disease. In this study, we compare outcomes of EUS-GE on benign versus malignant indications. METHODS: Consecutive patients from 12 international, tertiary care centers who underwent EUS-GE over 3 years were extracted in a retrospective registry. Demographic characteristics, procedure-related information and follow-up data was collected. Primary outcome was the rate of adverse events associated with EUS-GE and the comparison of the rate of adverse events in benign versus malignant diseases. Secondary outcomes included technical and clinical success as well as hospitalization admission. RESULTS: A total of 103 patients were included: 72 malignant and 31 benign. The characteristics of the patients undergoing EUS-GE is shown in Table 1. The mean age of the cohort was 68 years and 58 years for malignant and benign etiology. Gender distribution was 57% and 39% being females in malignant and benign etiology group, respectively. Clinical success, technical success, average procedure time, and hospital length of stay were similar in both groups. Patients with benign underlying etiology had significantly higher number of surgically altered midgut anatomy (P=0.0379). CONCLUSION: EUS-GE is equally efficient regardless of the underlying etiology (malignant vs. benign), and the adverse events both groups were comparable.

Endoscopic ultrasound-guided gastroenterostomy with lumen-apposing metal stents: a retrospective multicentric comparison of wireless and over-the-wire techniques.

BACKGROUND: Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) using lumen-apposing metal stents (LAMSs) appears to be effective and safe in gastric outlet obstruction (GOO); however, the EUS-GE procedure is not standardized, with the use of assisted or direct methods still debated. The aim of this study was to compare the outcomes of EUS-GE techniques focusing on an assisted with orointestinal drain wireless endoscopic simplified technique (WEST) and the nonassisted direct technique over a guidewire (DTOG). METHOD: This was a multicenter European retrospective study involving four tertiary centers. Consecutive patients who underwent EUS-GE for GOO between August 2017 and May 2022 were included. The primary aim was to compare the technical success and adverse event (AE) rates of the different EUS-GE techniques. Clinical success was also analyzed. RESULTS: 71 patients (mean [SD] age 66.2 10 years; 42.3 % men; 80.3 % malignant etiology) were included. Technical success was higher in the WEST group (95.1 % vs. 73.3 %; estimate of relative risk from odds ratio (eRR) 3.2, 95 %CI 0.94-10.9; P = 0.01). The rate of AEs was lower in the WEST group (14.6 % vs. 46.7 %; eRR 2.3, 95 %CI 1.2-4.5; P = 0.007). Clinical success was comparable between the two groups at 1 month (97.5 % vs. 89.3 %). The median follow-up was 5 months (range 1-57). CONCLUSION: The WEST resulted in a higher technical success rate with fewer AEs, with clinical success comparable with the DTOG. Therefore, the WEST (with an orointestinal drain) should be preferred when performing EUS-GE.

Peroral endoscopic myotomy and valve section for treatment of persistent and disabling dysphagia after laparoscopic fundoplication (with video).

BACKGROUND AND AIMS: The use of laparoscopic fundoplication (LF) to treat refractory GERD may induce refractory dysphagia (5%-10%). The management is complex, and peroral endoscopic myotomy (POEM) including valve incision is a new therapeutic option. METHODS: This retrospective study involved patients with postfundoplication refractory dysphagia treated by POEM associated with complete wrap incision. Patients were evaluated with Eckardt and dysphagia scores. Study objectives were to evaluate clinical and technical outcomes, adverse events, and GERD recurrence. RESULTS: Twenty-six patients, with a mean age of 57.3 ± 15.6 years, were included. Mean follow-up was 25.3 ± 17.6 months. The technical and clinical success rates were 96% and 84.6%, respectively. Among failures, 1 patient underwent Lewis-Santy, 2 required dilations, and 1 was lost to follow-up. Three late recurrences occurred and were endoscopically managed. Five patients (19%) had GERD recurrence that was mainly improved by proton pump inhibitors. CONCLUSIONS: POEM with fundoplication is a serious therapeutic option for managing persistent dysphagia after LF, with a low risk of GERD recurrence.

Risk factors for EUS-guided radiofrequency ablation adverse events in patients with pancreatic neoplasms: a large national French study (RAFPAN study).

BACKGROUND AND AIMS: EUS-guided radiofrequency ablation (EUS-RFA) has been described as a potentially curative option for solid and cystic pancreatic neoplasms. We aimed to assess the safety and efficacy of pancreatic EUS-RFA in a large study population. METHODS: A retrospective study retrieving all consecutive patients who underwent pancreatic EUS-RFA during 2019 and 2020 in France was conducted. Indication, procedural characteristics, early and late adverse events (AEs), and clinical outcomes were recorded. Risk factors for AEs and factors related to complete tumor ablation were assessed on univariate and multivariate analyses. RESULTS: One hundred patients (54% men, 64.8 ± 17.6 years old) affected by 104 neoplasms were included. Sixty-four neoplasms were neuroendocrine neoplasms (NENs), 23 were metastases, and 10 were intraductal papillary mucinous neoplasms with mural nodules. No procedure-related mortality was observed, and 22 AEs were reported. Proximity of pancreatic neoplasms (≤1 mm) to the main pancreatic duct was the only independent risk factor for AEs (odds ratio [OR), 4.10; 95% confidence interval [CI), 1.02-15.22; P = .04). Fifty-nine patients (60.2%) achieved a complete tumor response, 31 (31.6%) a partial response, and 9 (9.2%) achieved no response. On multivariate analysis, NENs (OR, 7.95; 95% CI, 1.66-51.79; P < .001) and neoplasm size <20 mm (OR, 5.26; 95% CI, 2.17-14.29; P < .001) were independently related to complete tumor ablation. CONCLUSIONS: The results of this large study confirm an overall acceptable safety profile for pancreatic EUS-RFA. Close proximity (≤1 mm) to the main pancreatic duct represents an independent risk factor for AEs. Good clinical outcomes in terms of tumor ablation were observed, especially for small NENs.

Training in esophageal peroral endoscopic myotomy (POEM) on an ex vivo porcine model: learning curve study and training strategy.

BACKGROUND: Peroral endoscopic myotomy (POEM) is a very effective treatment for achalasia. However, training remains non-standardized. We evaluated a training curriculum, including ex vivo cases, followed by patients' cases under expert supervision. The objective was to establish a learning curve of POEM. MATERIALS AND METHODS: Four operators having completed advanced endoscopy fellowship were involved. They had already observed > 30 cases performed by experts. They performed 30 POEMs standardized (tunnel and myotomy lengths) procedures on ex vivo porcine model. Procedural times, number/volume of injections, mucosal and serous perforations, and myotomy length were collected. The learning curve was assessed using dissection speed (DS) and a dedicated performance score (PS), including learning rate (LR) and learning plateau (LP). RESULTS: The operators completed all cases within 4 months (median of 3.5 cases/week). The mean procedural time was 43.3 min ± 14.4. Mean myotomy length was 70.0 mm ± 15.6 mm. Dissection speed averaged 1.78 mm/min ± 0.78. Using DS and PS as parameter, the LR was reached after 12.2 cases (DS = 2.0 mm/min) and 10.4 cases, respectively. When comparing the LP and the plateau phase, the DS was slower (1.3 ± 0.5 mm/min versus 2.1 ± 0.54 mm/min, p < 0.005) and perforations were decreased: 0.35 ± 0.82 in LP vs. 0.16 ± 0.44 in PP. Following this training, all operators performed 10 supervised cases and are competent in POEM. CONCLUSION: The association of observed cases and supervised ex vivo model training is effective for starting POEM on patients. The learning curve is 12 cases to reach a plateau.

EUS-guided hepaticogastrostomy in patients with obstructive jaundice after failed or impossible endoscopic retrograde drainage: A multicenter, randomized phase II Study.

Background and Objectives: Over the last two decades, EUS-guided hepaticogastrostomy (EUS-HGS) has emerged as a therapeutic alternative for patients with biliary obstruction and failed ERCP. Percutaneous transhepatic biliary drainage (PTBD) as the gold standard is associated with relevant morbidity and need for re-intervention. The aim of our work was to evaluate in a phase II study the safety and efficacy profile of EUS-HGS. A PTBD arm was considered a control group. Patients and Methods: We conducted a prospective, randomized, noncomparative phase II study in three French tertiary centers involving patients with benign or malignant obstructive jaundice after failure of ERCP. Patients were randomized to either PTBD or EUS-HGS. Results: Fifty-six patients (mean age 64 years) have been included between 2011 and 2015. Twenty-one underwent PTBD and thirty-five were drained using EUS-HGS. An interim analysis after the inclusion of 41 patients revealed an unexpected high 30-day morbidity rate for PTBD (13 out of 21 patients), justifying to stop randomization and inclusion in this control arm in 2013. The primary objective was reached with 10 out of the 35 EUS-HGS patients (28.6%) having observed complications (90%-level bilateral exact binomial confidence interval [CI] [16.4%-43.6%], left-sided exact binomial test to the objectified 50% unacceptable rate P = 0.0083). Both methods achieved comparable technical success rate (TSR) and clinical success rate (CSR) (TSR: PTBD 100% vs. EUS-HGS 94.3%, P = 0.28; CSR: PTBD 66.7% vs. EUS-HGS 80%, P = 0.35). Long-term follow-up showed EUS-HGS patients being at lower risk for re-intervention (relative risk = 0.47, 95% CI [0.27-0.83]). Conclusion: In cases of ERCP failure, EUS-HGS is a valuable alternative for biliary drainage with a high TSR and CSR. PTBD is associated with an unacceptable 30-day morbidity rate, whereas EUS-HGS seems to have a decent safety profile, suggesting that it may be the treatment of choice in appropriately selected patients.