Benefits of EUS-guided gastroenterostomy over surgical gastrojejunostomy in the palliation of malignant gastric outlet obstruction: a large multicenter experience.

BACKGROUND AND AIMS: Palliation of malignant gastric outlet obstruction (mGOO) allows resumption of peroral intake. Although surgical gastrojejunostomy (SGJ) provides durable relief, it may be associated with a higher morbidity, interfere with chemotherapy, and require an optimum nutritional status. EUS-guided gastroenterostomy (EUS-GE) has emerged as a minimally invasive alternative. We aimed to conduct the largest comparative series to date between EUS-GE and SGJ for mGOO. METHODS: This multicenter retrospective study included consecutive patients undergoing SGJ or EUS-GE at 6 centers. Primary outcomes included time to resumption of oral intake, length of stay (LOS), and mortality. Secondary outcomes included technical and clinical success, reintervention rates, adverse events (AEs), and resumption of chemotherapy. RESULTS: A total of 310 patients were included (EUS-GE, n = 187; SGJ, n = 123). EUS-GE exhibited significantly lower time to resumption of oral intake (1.40 vs 4.06 days, P < .001), at lower albumin levels (2.95 vs 3.33 g/dL, P < .001), and a shorter LOS (5.31 vs 8.54 days, P < .001) compared with SGJ; there was no difference in mortality (48.1% vs 50.4%, P = .78). Technical (97.9% and 100%) and clinical (94.1% vs 94.3%) success was similar in the EUS-GE and SGJ groups, respectively. EUS-GE had lower rates of AEs (13.4% vs 33.3%, P < .001) but higher reintervention rates (15.5% vs 1.63%, P < .001). EUS-GE patients exhibited significantly lower interval time to resumption of chemotherapy (16.6 vs 37.8 days, P < .001). Outcomes between the EUS-GE and laparoscopic (n = 46) surgical approach showed that EUS-GE had shorter interval time to initiation/resumption of oral intake (3.49 vs 1.46 days, P < .001), decreased LOS (9 vs 5.31 days, P < .001), and a lower rate of AEs (11.9% vs 17.9%, P = .003). CONCLUSIONS: This is the largest study to date showing that EUS-GE can be performed among nutritionally deficient patients without affecting the technical and clinical success compared with SGJ. EUS-GE is associated with fewer AEs while allowing earlier resumption of diet and chemotherapy.

Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial.

BACKGROUND AND AIMS: Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and requires repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN. METHODS: This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN ≥6 cm and ≤22 cm and with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life. RESULTS: Thirty patients (mean age, 55 years; 60% men) underwent DEN with no device-related adverse events. Of 30 patients, 15 (50%) achieved complete debridement in 1 session and 20 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range, 1-7) were required. Median hospital stay was 10 days (interquartile range, 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated with the total number of interventions (ρ = .363, P = .049). CONCLUSIONS: The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed. (Clinical trial registration number: NCT03694210.).

Is transoral incisionless fundoplication (TIF) an answer to post-peroral endoscopic myotomy gastroesophageal reflux? A multicenter retrospective study.

BACKGROUND: The use of peroral endoscopic myotomy (POEM) for achalasia has a high incidence of post-procedural gastroesophageal reflux (GER). Transoral incisionless fundoplication (TIF) may be an ideal endoscopic treatment. We report our experience with the use of post-POEM TIF. METHODS: In this multicenter retrospective study, post-POEM patients with GER who underwent TIF were included. The study end points were: (i) technical success; (ii) safety; (iii) effectiveness (changes in symptoms, scores, proton pump inhibitor [PPI] use, pH studies). RESULTS: 12 patients underwent TIF after POEM, nine of whom had daily symptoms, with 91.7% requiring twice daily (BID) PPIs. Technical success was achieved in all patients. Two adverse events occurred. There were significant decreases in the percentage of patients on BID PPIs (P = 0.03), frequency of daily symptoms (P = 0.03), Reflux Severity Index questionnaire, and GERD Health-related Quality of Life scores (P = 0.03 and P = 0.003; n = 6). pH studies performed in seven of the patients showed a significant reduction in the mean DeMeester score (P = 0.05) and mean percentage acid exposure time (P = 0.04). CONCLUSION: Our experience suggests that TIF may be effective and safe in treating GER after POEM. Larger prospective trials are needed.

Clinical and technical outcomes of patients undergoing endoscopic ultrasound-guided gastroenterostomy using 20-mm vs. 15-mm lumen-apposing metal stents.

BACKGROUND: Most studies on endoscopic ultrasound (EUS)-guided gastroenterostomy (EUS-GE) for palliation of malignant gastric outlet obstruction (GOO) utilized a 15-mm lumen-apposing metal stent (LAMS). More recently, a 20-mm LAMS has become available. This study aimed to compare rates of technical and clinical success and adverse events (AEs) in patients undergoing EUS-GE using a 20-mm vs. 15-mm LAMS. METHODS: Patients who underwent EUS-GE with 15-mm or 20-mm LAMS for malignant GOO during the period from January 2018 to October 2020 were included. The primary outcome was clinical success, defined as an increase in the gastric outlet obstruction score (GOOS) by at least 1 point during follow-up. Secondary outcomes were technical success, maximum tolerated diet, re-intervention rate, and rate/severity of AEs. RESULTS: 267 patients (mean age 67 years, 43 % women) with malignant GOO from 19 centers underwent EUS-GE. Clinical success rates were similar for the 15-mm and 20-mm stents (89.2 % [95 %CI 84.2 %-94.2 %] vs. 84.1 % [77.4%-90.6 %], respectively). However, a significantly higher proportion of patients in the 20-mm group tolerated a soft solid/complete diet at the end of follow-up (91.2 % [84.4 %-95.7 %] vs. 81.2 % [73.9 %-87.2 %], P = 0.04). Overall, AEs occurred in 33 patients (12.4 % [8.4 %-16.3 %]), with similar rates for 15-mm and 20-mm stents (12.8 % [7.5 %-18.2 %] vs. 11.8 % [6 %-17.6 %]), including incidence of severe/fatal AEs (2 % [0.4 %-5.8 %] vs. 3.4 % [0.9 %-8.4 %]). CONCLUSIONS: The 20-mm and 15-mm LAMS show similar safety and efficacy for patients undergoing EUS-GE for malignant GOO. The 20-mm LAMS allows a more advanced diet and is, thus preferred for EUS-GE.

Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use.

BACKGROUND: The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing. METHODS: The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices. RESULTS: We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity. CONCLUSIONS: The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.

Initial multicenter experience with nitrous oxide cryoballoon for treatment of flat duodenal adenomas (with video).

BACKGROUND AND AIMS: EMR is the preferred endoscopic therapy for duodenal adenomas (DAs) but is associated with an overall adverse event rate of 26%. Cryotherapy using a Cryoballoon Focal Ablation System (CbFAS) can safely and effectively eradicate esophageal intestinal metaplasia. We report our first experience with cryoballoon ablation for treatment of flat DAs. METHODS: This was an American, multicenter, retrospective study involving 5 centers. DAs (Paris 0-IIa and 0-IIb) were treated with nitrous oxide for 5 to 12 seconds using CbFAS. Follow-up EGD was performed at 3 to 12 months. RESULTS: Seventeen DAs (mean size, 22.7 ± 14.3 mm; 12 tubular, 5 tubulovillous) from 13 patients (mean age, 66.5 ± 9.99 years; 61.5% males) were included in the study. Thirteen of 17 DAs (76.5%) had failed previous treatment, and 4 of 17 (23.5%) were treatment naÏve. All procedures were technically successful and achieved a >50% decrease in size after cryoballoon ablation There was no increase in size or progression of disease for any lesions. Overall, treatment was completed in 15 of 17 patients, and recurrence-free survival was achieved in 12 of 17 (71%) after a median follow-up of 15.5 months (interquartile range [IQR], 6.8-19.4). The median cryoablation time per polyp was 4 minutes (IQR, 1-7.5 minutes), and the median total procedure time was 25 minutes (IQR, 22-30.5 minutes). There were no intra- or postprocedural adverse events. CONCLUSIONS: Nitrous oxide cryoballoon ablation of nonpolypoid DAs is feasible, with promising safety and efficacy.

Initial clinical experience of a steerable access device for EUS-guided biliary drainage.

BACKGROUND AND AIMS: EUS-guided biliary drainage (EUS-BD) has been used as a rescue procedure after failed endoscopic retrograde cholangiography (ERC), and there is growing interest in EUS-BD as a primary therapy for distal malignant biliary obstruction. After EUS-guided needle puncture of an obstructed bile duct, directional control of wire advancement remains an area of need, potentially addressed by a new steerable EUS access system. The aim of this study was to evaluate the safety and efficacy of this novel steerable access system in patients undergoing EUS-BD after failed ERC. METHODS: We performed a retrospective study of prospectively acquired data at 3 tertiary academic hospitals. Consecutive patients who had failed ERC followed by EUS-BD using the access device were included. Primary outcomes were safety and technical feasibility (successful completion of EUS-BD). Secondary outcomes were clinical success (75% improvement in liver function tests at 30 days) and device performance. RESULTS: Twenty-two consecutive patients underwent EUS-BD between October 10, 2018 and March 3, 2019. Needle puncture and selective wire advancement in the intended direction were both successful in 100% of cases (22/22). Technical success was 95% (21/22). Fifty-nine percent (13) underwent rendezvous, 32% (7) underwent choledochoduodenostomy, and 4.5% (1) underwent hepaticogastrostomy. One patient (4.5%) underwent percutaneous transhepatic cholangiography. There were no cases of wire shearing. The adverse event rate was 4.5% (mild pancreatitis in 1 patient). There was no bile leak, bleeding, or death at 30 days' follow-up. CONCLUSIONS: This first clinical experience with a steerable access system for EUS-BD suggests it is safe and effective, particularly with regard to controlling direction of wire advancement.

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

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

International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage.

BACKGROUND AND AIMS: High rates of technical and clinical success were reported for lumen-apposing metal stent (LAMS) placement for peripancreatic fluid collection (PFC) drainage. However, data on the adverse event (AE) rates are heterogeneous. The aim of this study was to evaluate the incidence, severity, management, and risk factors of AEs related to the use of LAMSs for drainage of PFCs in a large cohort of patients. METHODS: This is a multicenter, international, retrospective review from 15 centers of all patients who underwent placement of LAMSs for the management of PFCs. A nested case-control study was conducted in patients with (case) or without (control) AEs. RESULTS: Three hundred thirty-three procedures in 328 patients were performed (5 patients treated with 2 LAMSs). Technical success was achieved in 321 patients (97.9%). Three hundred four patients were finally included in the study (7 excluded for lost to follow-up information; 10 excluded for deaths unrelated to LAMSs). The rate of clinical success was 89.5%. Seventy-nine LAMS-related AEs occurred in 74 of 304 patients (24.3%), after a mean time of 25.3 days (median, 18 days; interquartile range, 6-30) classified as 20 (25.3%) mild, 54 (68.4%) moderate, or 5 (6.3%) severe. On multivariable analysis compared with control subjects, cases were more likely to have walled-off necrosis (WON) versus pancreatic pseudocysts (odds ratio, 2.18; 95% confidence interval, 1.09-4.46; P = .028), whereas cases were less likely to have undergone tract (balloon) dilation (yes vs no; odds ratio, .47; 95% confidence interval, .22-.93; P = .034). CONCLUSIONS: Data from this large international retrospective study confirm that the use of LAMSs for management of PFCs has excellent technical and good clinical success rates. The rate of AEs, however, is not negligible and should be carefully considered before using these stents for drainage of PFCs and in particular for WON. Further prospective studies are needed to confirm these findings. (Clinical trial registration number: NCT03544008.).

Cryoballoon ablation for gastric pouch and/or outlet reduction in patients with weight regain post Roux-en-Y gastric bypass.

BACKGROUND: Cryoballoon ablation could induce stricture formation to achieve outlet and pouch reduction in patients regaining weight after Roux-en-Y gastric bypass (RYGB). This pilot study aimed to assess technical feasibility and short-term efficacy. METHODS: A retrospective chart review (January - November 2018) at two academic centers identified patients with weight regain post-RYGB, treated with cryoablation if pouch > 4 cm and/or outlet > 15 mm. Patients were scheduled for surveillance endoscopies at 8 weeks. RESULTS: 22 patients presented 10.5 years (SD 4.42) post-RYGB with weight regain of 30.9 kg (SD 13.7). Technical success was 89.5 % for outlet ablation and 93.0 % for pouch ablation. From baseline to 8 weeks, the outlet was reduced from 24.1 mm (95 % confidence interval [CI] 19.8 to 28.5) to 17.1 mm (95 %CI 13.1 to 21.1; P < 0.001), and pouch from 5 cm (95 %CI 4.1 to 5.9) to 3.9 cm (95 %CI 2.6 to 5.1; P < 0.05). Total body weight loss at 8 weeks was 8.1 % (SD 12.8 %). CONCLUSION: Cryoablation appears technically feasible and effective for outlet and/or pouch reduction in the short term.

Endoscopic ultrasound-guided drainage of pancreatic walled-off necrosis using 20-mm versus 15-mm lumen-apposing metal stents: an international, multicenter, case-matched study.

BACKGROUNDS: Endoscopic ultrasound (EUS)-guided placement of lumen-apposing metal stents (LAMSs) has gained popularity for the treatment of pancreatic walled-off necrosis (WON). We compared the 20-mm and 15-mm LAMSs for the treatment of symptomatic WON in terms of clinical success and adverse events. METHODS: We conducted a retrospective, case-matched study of 306 adults at 22 tertiary centers from 04/2014 to 10/2018. A total of 102 patients with symptomatic WON who underwent drainage with 20-mm LAMS (cases) and 204 patients who underwent drainage with 15-mm LAMS (controls) were matched by age, sex, and drainage approach. Conditional logistic regression analysis was performed to compare clinical success (resolution of WON on follow-up imaging without reintervention) and adverse events (according to American Society for Gastrointestinal Endoscopy criteria). RESULTS: Clinical success was achieved in 92.2 % of patients with 20-mm LAMS and 91.7 % of patients with 15-mm LAMS (odds ratio 0.92; P = 0.91). Patients with 20-mm LAMS underwent fewer direct endoscopic necrosectomy (DEN) sessions (mean 1.3 vs. 2.1; P < 0.001), despite having larger WON collections (transverse axis 118.2 vs. 101.9 mm, P = 0.003; anteroposterior axis 95.9 vs. 80.1 mm, P = 0.01). There was no difference in overall adverse events (21.6 % vs. 15.2 %; P = 0.72) and bleeding events (4.9 % vs. 3.4 %; P = 0.54) between the 20-mm and 15-mm LAMS groups, respectively. CONCLUSIONS: The 20-mm LAMS showed comparable clinical success and safety profile to the 15-mm LAMS, with the need for fewer DEN sessions for WON resolution.

Endoscopic Myotomy for Foregut Motility Disorders.

Peroral endoscopic myotomy (POEM) is an advanced endoscopic procedure classically performed for the treatment of achalasia. The procedure is based on principles of submucosal endoscopy and is composed of a mucosal incision, submucosal tunneling, myotomy, and mucosal closure. Multiple published studies that collectively include more than 6000 patients reported clinical success in more than 80% to 90% of patients. Recent literature also suggested durability of response over a medium-term follow-up. POEM is associated with a low rate of adverse events when performed by experienced operators. Gastroesophageal reflux is not infrequent after POEM but does not seem significantly different from reflux that occurs after Heller myotomy. POEM also seems to be effective in the treatment of spastic esophageal disorders (eg, jackhammer and diffuse esophageal spasm). Last, the role of gastric POEM (G-POEM) in the treatment of gastroparesis has been investigated in recent studies with promising results.

Safety and feasibility of performing peroral endoscopic myotomy as an outpatient procedure with same-day discharge.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) has emerged as a promising treatment option for achalasia and other foregut dysmotility disorders. However, much of the current postprocedural care, such as mandatory admission and routine esophagrams, has been adapted from current surgical practices and may not in fact be necessary. Here, we describe our algorithm and outcomes for same-day discharge. METHODS: Outcomes of 103 consecutive patients who underwent POEM for achalasia and other foregut dysmotility disorders from January 2015 to December 2018 were analyzed. Patients were discharged on the same day without esophagrams following a predetermined algorithm based on procedural adverse events and postprocedural pain. Patients were closely monitored after discharge for adverse events at 24 and 48 hours and then routinely in the office setting. RESULTS: Of the 103 POEMs, 101 were completed successfully. A total of 62.4% of patients were discharged safely on the same day, 29.7% were admitted for mild pain, and 7.9% were admitted for observation for other reasons. Overall, there were no serious adverse events at any time point. Univariate analysis identified duration of disease greater than 3 years, longer length of procedure (50.9 vs 68.5 min, P < .0001), and longer length of myotomy (7.2 vs 8.5 cm, P < .0068) as significant factors associated with postprocedural pain requiring admission. CONCLUSIONS: Although same-day discharge and foregoing routine esophagram have been suggested by many, this routine has not been systematically implemented. This series suggests that an algorithm for same-day discharge based on postprocedure chest pain and procedural complexity is both safe and feasible.

EUS-guided drainage of postsurgical fluid collections using lumen-apposing metal stents: a multicenter study.

BACKGROUND AND AIMS: Postsurgical fluid collections (PSFCs) are traditionally drained either percutaneously or surgically. Endoscopic drainage offers several advantages compared with either percutaneous or surgical approaches, including avoiding repeat surgery or the need to have a percutaneous drain in place for weeks. There are very little data regarding the use of lumen-apposing metal stents (LAMSs) in the drainage of PSFCs. We aim to study the technical and clinical success and adverse events (AEs) of using LAMSs in the drainage of PSFCs. METHODS: Collaborators from 8 centers retrospectively reviewed their endoscopic databases to find procedures using LAMSs for drainage of PSFCs. Technical success (successful placement of LAMSs into the fluid collection), clinical success (complete resolution of the fluid collection on repeat imaging or endoscopy), and intraprocedure and postprocedure AEs were measured. RESULTS: Forty-seven patients were identified with PSFCs after various surgeries. Thirteen patients had failed previous percutaneous or surgical drainage attempts. Fluid collections averaged 78.6 mm (range, 47-150 mm) in size. The most common site of stent placement was transgastric, followed by rectum and duodenum. Technical success rate was 93.6% and clinical success rate 89.3%. The intraprocedural AE rate was 4.25% and postprocedural AE rate 6.4%. There was 1 death unrelated to the procedure. CONCLUSIONS: The use of LAMSs to drain PSFCs has a high technical and clinical success rate with low AEs. For collections that are favorably located adjacent to the stomach, duodenum, or rectum, LAMS placement is a viable alternative to repeat surgery or percutaneous drainage.

Digital pancreatoscopy in the evaluation of main duct intraductal papillary mucinous neoplasm: a multicenter study.

BACKGROUND: The aim of this study was to investigate the outcomes of digital pancreatoscopy in main duct intraductal papillary mucinous neoplasm (MD-IPMN). METHODS: This was a multicenter retrospective study. Outcomes analyzed were safety, incremental pathology yield compared with previous cross-sectional/endoscopic ultrasound (EUS) imaging, and whether the surgical procedure was dictated by the pancreatoscopy. RESULTS: A total of 31 patients were enrolled from six tertiary care centers. Overall, 42 % of cases had findings on pancreatoscopy that were not seen on cross-sectional imaging or EUS. Digital pancreatoscopy dictated the type of surgery performed in 13 patients (42 %) who underwent surgery. However, in patients with a diffusely dilated pancreatic duct (> 10 mm), the pancreatoscopy dictated the type of surgery in 77 % of cases vs. 17 % of cases in the focally dilated pancreatic duct group (10/13 vs. 3/18; P = 0.001). CONCLUSION: Digital pancreatoscopy should be considered in the diagnostic algorithm of MD-IPMN in patients with a diffusely dilated pancreatic duct and without any focal lesions seen on cross-sectional imaging or EUS.

Gastric per-oral endoscopic myotomy for refractory gastroparesis: results from the first multicenter study on endoscopic pyloromyotomy (with video).

BACKGROUND AND AIMS: Gastric per-oral endoscopic myotomy (G-POEM) recently has been reported as minimally invasive therapy for gastroparesis. The aims of this study were to report on the first multicenter experience with G-POEM and to assess the efficacy and safety of this novel procedure for patients with gastroparesis with symptoms refractory to medical therapy. METHODS: All patients with gastroparesis who underwent endoscopic pyloromyotomy (G-POEM) at 5 medical centers were included. Procedures were performed following the same principles as esophageal POEM. Clinical response was defined as improvement in gastroparetic symptoms with absence of recurrent hospitalization. Adverse events were graded according to the American Society for Gastrointestinal Endoscopy lexicon. RESULTS: A total of 30 patients with refractory gastroparesis (11 diabetic, 12 postsurgical, 7 idiopathic) underwent G-POEM. Previous therapies included Botox injection in 12, transpyloric stenting in 3, and PEG with jejunal extension (PEGJ) in 1. Nausea/vomiting were the predominant symptoms in 25 patients. Weight loss was present in 27 patients with an average of 10% loss of body weight. G-POEM was completed successfully in all 30 (100%) patients with a mean procedure time of 72 minutes (range, 35-223 min). The mean myotomy length was 2.6 ± 2.3 cm. The mean length of hospital stay was 3.3 days (range, 1-12 days). Two adverse events occurred in 2 (6.7%) patients, including 1 capnoperitoneum and 1 prepyloric ulcer, rated as mild and severe, respectively. Clinical response was observed in 26 (86%) patients during a median follow-up of 5.5 months. Four patients (2 diabetic, 1 postsurgical, 1 idiopathic cause) did not respond to G-POEM. Repeat gastric emptying scan was obtained in 17 patients, normalized in 8 (47%), and improved in 6 (35%) patients. CONCLUSION: G-POEM is a technically feasible procedure. This small non-randomized study suggests the effectiveness of G-POEM for the treatment of patients with gastroparesis refractory to medical therapy. It concomitantly results in normalization of GES in a significant proportion of treated patients.