Conventional versus oblique fiber-sparing endoscopic myotomy for achalasia cardia: a randomized controlled trial (with videos).

BACKGROUND AND AIMS: GERD is common after peroral endoscopic myotomy (POEM). Selective sparing of oblique fibers may reduce the incidence of reflux esophagitis after POEM. In this study, we compared the incidence of GERD between conventional myotomy (CM) versus oblique fiber-sparing (OFS) myotomy in patients with achalasia. METHODS: Eligible patients with type I and II achalasia who underwent POEM from January 2020 to October 2020 were randomized into 2 groups (CM and OFS myotomy). Exclusion criteria were type III achalasia, sigmoid esophagus, and history of Heller's myotomy. The primary study outcome was incidence of reflux esophagitis (at least grade B) in the 2 groups. Secondary outcomes were reflux symptoms, esophageal acid exposure, clinical success, and adverse events. RESULTS: One hundred fifteen patients were randomized into CM (n = 58) and OFS myotomy (n = 57) groups. POEM was technically successful in all patients. Overall, reflux esophagitis was found in 56 patients (48.7%). The incidence of at least grade B esophagitis was similar in both groups (CM vs OFS myotomy: 25.9% vs 31.6%, P = .541). The mean number of reflux episodes (48.2 ± 36.6 vs 48.9 ± 40.3, P = .933), increased esophageal acid exposure >6% (45.5% vs 31.7%, P = .266), and high DeMeester scores (38.6% vs 41.5%, P = .827) were similar in both groups. There was no difference in the rate of symptomatic reflux (GERD questionnaire score >7) or use of proton pump inhibitors at 1 year. CONCLUSIONS: Sparing of sling fibers has no significant impact on the incidence of significant reflux esophagitis after POEM. Novel strategies need to be explored to prevent reflux after POEM. (Clinical trial registration number: NCT04229342.).

Pre-medication with simethicone and N-acetyl cysteine for improving mucosal visibility during upper gastrointestinal endoscopy: A randomized controlled trial.

BACKGROUND AND AIM: Diagnostic performance of esophagogastroduodenoscopy (EGD) may be compromized due to adherent mucus and foam. In this study, we aimed at assessing the impact of premedication on mucosal visibility during endoscopy. METHODS: This is a double-blinded (patient and investigator), randomized trial conducted at a tertiary care centre. Patients were randomized into four groups: A (water), B (simethicone [S]), C (N-acetyl cysteine [NAC]), D (S + NAC). Premedication solutions were administered 10-30 minutes before endoscopy and mucosal visibility graded from 1 (best) to 4 (worst) (1 best, 4 worst). Total mucosal visibility scores (TMVS) from six sites ranged from 6 (best) to 24 (worst) points. The primary outcome of study was comparison of TMVS between simethicone and combination (S + NAC) premedication groups. Secondary outcomes were adverse events and impact of endoscopy timing on TMVS. RESULTS: Total 800 patients (39 years, 68.8% males) were randomized into four groups. Median TMVS were significantly lower in groups B (7 [6-8]) and D (8 [6-9]) as compared to A (11 [9-13]) and C (10 [8-12]). Proportion of cases with adequate gastric mucosal visibility (score < 7) was 26% in group A, 71% in group B, 36% in group C and 79% in group D. There was no difference in TMVS in groups A and C (p = 0.137). TMVS were significantly lower in late (> 20-30 minutes) vs. early (10-20 minutes) endoscopy sub-group (8 [7-11] vs, 9 ([7-11], p = 0.001). However, TMVS were similar between group B and group D in early endoscopy group (p = 0.451). There was no significant difference in the lesion detection rate among the different premedication drugs (p > 0.05). CONCLUSIONS: Premedication with simethicone or combination (simethicone and NAC) significantly improves mucosal visibility during EGD. If early endoscopy is indicated, simethicone provides similar mucosal visibility and may be an effective alternative to combined premedication. TRIAL REGISTRATION: NCT05951712.

Per-oral endoscopic myotomy in cases with prior Heller's myotomy: Outcomes at a median follow-up of 5 years.

BACKGROUND AND AIM: Per-oral endoscopic myotomy (POEM) is an established treatment for achalasia cardia. However, data on the long-term efficacy of POEM in patients with failed Heller's myotomy (HM) are limited. The purpose of this study was to evaluate the long-term outcomes of POEM in patients with persistent or recurrent symptoms following HM. METHODS: Data of patients with recurrence of symptoms after HM who underwent POEM (September 2013 to December 2022) were analyzed, retrospectively. Primary outcome was clinical success [Eckardt score (ES) ≤ 3]. Secondary outcomes included improvement of manometry parameters, barium emptying at 5 min and gastroesophageal reflux (esophagitis and increased esophageal acid exposure) after POEM. RESULTS: Seventy-two cases (45.9 ± 13.4 years, 43 men) with history of HM were included in the study. The subtypes of achalasia were type 1 (40.3%), type 2 (37.5%), and unknown (19.4%). Prior treatment included HM in 48 (66.7%), HM plus pneumatic dilatation in 20 (27.8%), and HM plus pneumatic dilatation and Botox in 4 (5.5%). Technical success was achieved in all cases. Mean length of myotomy was 10.7 ± 3.3 cm, and mean procedure duration was 59.2 ± 25.9 min. There was significant improvement in ES (pre-POEM 6.5 ± 1.8 vs post-POEM 0.7 ± 0.7), lower esophageal sphincter pressure pressures (31.7 ± 12.5 vs 13.3 ± 5.7 mmHg) and barium emptying (14.2 ± 4.2 vs 2.4 ± 3.1 cm) after POEM. At a median follow-up of 63 months (IQR 40-95), clinical success (ES ≤ 3) was documented in 58 (80.6%) patients. Reflux esophagitis and increased esophageal acid exposure were recorded in 28 of 49 (57.1%) and 11 of 20 (55%) patients, respectively. CONCLUSION: POEM is a durable treatment modality in cases with relapse of symptoms after HM.

Single-Versus Multiple-Dose Antimicrobial Prophylaxis in Peroral Endoscopic Myotomy: A Randomized Controlled Study (SMAPP Trial).

Infections are uncommon after peroral endoscopic myotomy (POEM) procedure. However, prophylactic antibiotics are routinely administered for variable duration during peri-operative period. In this study, we aimed to determine the difference in the rate of infections between single (SD-A) and multiple doses (MD-A) antibiotic prophylaxis groups. The study was a prospective, randomized, non-inferiority trial conducted at a single tertiary care centre from Dec 2018 to Feb 2020. Eligible patients undergoing POEM were randomized into SD-A and MD-A groups. SD-A group received one dose of antibiotic (IIIrd gen cephalosporin) within 30-min of POEM. In the MD-A group, the same antibiotic was administered for a total of three days. Primary aim of the study was to determine the incidence of infections in the two groups. Secondary outcomes included incidence of fever (> 100 °F), inflammatory markers [erythrocyte sedimentation rate (ESR), c-reactive protein(CRP)], serum procalcitonin and adverse events related to antibiotics. (NCT03784365). 114 patients were randomized to SD-A (57) and MD-A (57) antibiotic groups. Mean post-POEM CRP (0.8 ± 0.9 vs 1.5 ± 1.6), ESR (15.8 ± 7.8 20.6 ± 11.7) and procalcitonin (0.05 ± 0.04 0.29 ± 0.58) were significantly higher after POEM (p = 0.001). Post-POEM inflammatory markers (ESR, CRP and procalcitonin) were similar in both the groups. Fever on day-0 (10.5% vs 14%) and day-1 (1.7% vs 3.5%) was detected in similar proportion of patients. Post-POEM infections were recorded in 3.5% (1.7% vs 5.3%, p = 0.618). Single dose of antibiotic is non-inferior to multiple dose antibiotic prophylaxis. Elevation of inflammatory markers and fever after POEM represents inflammation and does not predict infection after POEM.

Predictors of Long-Term Outcomes, Recurrent Dysphagia, and Gastroesophageal Reflux After Per-oral Endoscopic Myotomy in Esophageal Motility Disorders.

BACKGROUND: There is limited data on long-term outcomes of per-oral endoscopic myotomy (POEM). In this study, we aim to evaluate the efficacy of POEM in patients who completed a minimum follow-up of 5 years. METHODS: Data of patients who underwent POEM and completed ≥ 5-year follow-up were analyzed, retrospectively. Primary outcome of study was clinical success (Eckardt ≤ 3) at ≥ 5 years after POEM. Secondary outcomes included predictors of dysphagia and symptomatic gastroesophageal reflux disease (GERD) on long-term follow-up. RESULTS: Three hundred nineteen patients (males 182, mean age 40.5 ± 14.2 years) completed a median of 73-(60-89) month follow-up. Esophageal motility disorders included idiopathic achalasia (type I 26.6%, type II 60.8%, type III 5.6%) and Jackhammer esophagus or distal esophageal spasm (2.8%). POEM was technically successful in 307 (96.2%) patients. Long-term success was 92.6% (overall), 92.1% (type I), 94.7% (type II), 87.5% (type III), and 75% (Jackhammer esophagus/distal esophageal spasm). Symptomatic GERD and reflux esophagitis were detected in 28.9% and 35.3% patients, respectively. On multivariate analysis, young age and female gender were independent risk factors for recurrent dysphagia (p = 0.037) and symptomatic GERD after POEM (p = 0.025), respectively. Lower post-POEM lower esophageal sphincter pressure was an independent predictor for reflux esophagitis (p = 0.016). CONCLUSION: POEM is an effective and durable treatment for achalasia and non-achalasia spastic motility disorders. Young patients and females may be at higher risk for recurrent dysphagia and symptomatic GERD, respectively.

POEM Is a Durable Treatment in Children and Adolescents With Achalasia Cardia.

Background and Aim: Per-oral endoscopic myotomy (POEM) is emerging as an effective treatment for pediatric achalasia. There are limited data on the long-term efficacy of POEM in children and adolescents with achalasia. In this study, we aim to evaluate the outcomes of POEM at ≥4 years follow-up. Method: The data of consecutive children who underwent POEM (September 2013-July 2021) and completed at least 4 years follow-up were analyzed retrospectively. The primary outcome was clinical success (Eckardt ≤ 3) at ≥4 years follow-up. The secondary outcomes included the prevalence of gastroesophageal reflux disease (GERD) and predictors of recurrent symptoms (Eckardt ≥2) after POEM. Results: A total of 69 children underwent POEM for achalasia during the study period. Of these, 41 (59.4%) children completed ≥4 years [mean 68.5 months (range 48-94)] follow-up, and 38 were included in the final analysis. The subtypes of achalasia included type I (28.9%), type II (60.5%), and type III (2.6%). There was a history of prior treatment in 11 children (28.9%). Clinical success was recorded in 36 (94.7%) patients who successfully underwent POEM. Recurrent symptoms (Eckardt ≥ 2) were noticed in 12 (31.6%) children at ≥4 years. On multivariate analysis, there were no identifiable factors which predicted recurrent symptoms after POEM. Symptomatic GERD and erosive esophagitis were detected in 13.8% (4/29) and 57.1% (8/14) of the children, respectively. Conclusion: POEM is a durable treatment modality for achalasia in the pediatric population irrespective of the sub-type of achalasia and history of prior treatment.

Per-oral Endoscopic Myotomy with Division of Septum (D-POEM) in Epiphrenic Esophageal Diverticula: Outcomes at a Median Follow-Up of Two Years.

Esophageal epiphrenic diverticula (EED) are rare pulsion-type outpouchings at the lower end of esophagus. Traditionally, surgery has been performed in EED. More recently, per-oral endoscopic myotomy with septotomy (D-POEM) has emerged as an option in these cases. In this study, we aim to determine the efficacy and safety of D-POEM in cases with EED. The data of cases who underwent D-POEM in cases with EED from March 2013 to Nov 2020 were analyzed, retrospectively. The primary outcome of the study was clinical success. Secondary outcomes included technical success, procedure duration, reflux esophagitis, and adverse events. 13 patients (males 9, 48.07 ± 17.55 years) with EED underwent D-POEM during the study period. Median size of the EED was 45 mm (range 25-70). Associated esophageal motility disorder was found in 10 (76.9%) cases including type II achalasia (3), type I (3), hypercontractile esophagus (2), and unspecified (2). Technical success was achieved in 12 (92.3%) cases. Median length of total and gastric myotomies were 10 cm (range 6-20) and 3 cm (1-3), respectively. At a median follow-up of 25 months, clinical success was achieved in 84.6% cases. Mean integrated relaxation pressures reduced significantly after POEM procedure (25.80 ± 13.24 vs 9.40 ± 3.10, p = 0.001). There was one major adverse event requiring surgical intervention. D-POEM is an effective procedure in cases with EED. Long-term follow-up studies are required to ascertain the durability of response in these cases.

Endoscopic full-thickness plication for the treatment of PPI-dependent GERD: results from a randomised, sham controlled trial.

BACKGROUND: The majority of endoscopic antireflux procedures for GERD are cumbersome to use and randomised long-term data are sparse. We conducted such a trial to determine the efficacy and safety of a novel, easy to use endoscopic full-thickness fundoplication (EFTP) device in patients with GERD. DESIGN: Patients with proton pump inhibitor (PPI)-dependent GERD were randomised to either EFTP or a sham procedure in 1:1 ratio. The primary endpoint was ≥50% improvement in the health-related quality of life (GERD-HRQL) score at 3 months. Secondary end points included improvement in GERD-HRQL, reflux symptom scores, PPI usage, oesophageal acid exposure and reflux episodes and endoscopic findings at 3, 6 and 12 months. RESULTS: Seventy patients were randomised; 35 in each group with a median (IQR) age of 36 (29-42) years, 71.4% males. 70% had non-erosive reflux disease on endoscopy with a mean DeMeester score of 18.9 (±19.93). The mean (±SD) duration of EFTP procedure was 17.4 (±4) min. The primary end point was more frequently achieved in the EFTP group (65.7% vs 2.9%; p<0.001). Median (IQR) % improvement in GERD-HRQL was significantly higher in the EFTP group at 6 (81.4 (60.9-100.0) versus 8.0 (2.2-21.6); p<0.001) and 12 (92.3 (84.4-100.0) versus 9.1 (4.8-36.0); p<0.001) months. In the EFTP group, 62.8% patients were off-PPI at 12 months compared with 11.4% in the sham group (p<0.001). pH-metry parameters partially improved at 3 months, (n=70; total reflux episodes in EFTP arm and non-acid reflux episodes for EFTP vs sham) but not at 12 months (n=27); endoscopic oesophagitis was seen in 0% in the treatment (n=18) and 5 (29.4%) in the control group (n=17) at 12 months. No major procedure-related adverse events were encountered in either group. CONCLUSION: EFTP using a novel device is safe and effective in improving quality of life in patients with PPI dependent mostly non-erosive reflux disease at short and long terms; objective parameters showed a limited response rate. TRIAL REGISTRATION NUMBER: NCT03322553.

Endoscopic sleeve gastroplasty - minimally invasive treatment for non-alcoholic fatty liver disease and obesity.

INTRODUCTION: Adequate weight loss can lead to reduction in steatosis, inflammation, and fibrosis in patients with obesity and non-alcoholic fatty liver disease (NAFLD). We evaluated the role of endoscopic sleeve gastroplasty (ESG) in patients with obesity and NAFLD. METHODS: In this single-center prospective study, consecutive adult patients with NAFLD who underwent ESG between November 2018 and May 2019 were included. The primary outcome was the impact of ESG on hepatic parameters: change in alanine aminotransferase (ALT), hepatic steatosis index (HSI), NAFLD fibrosis score (NFS), fibrosis-4 index (FIB-4), and aspartate aminotransferase (AST)-to-platelet ratio index (APRI) from baseline to 6 and 12 months. Secondary outcomes included change in glycated hemoglobin (HbA1c), percentage weight loss, and safety. Analysis of variance with repeated measures was used for statistical analysis. RESULTS: A total of 26 patients (mean age [SD] 41.5 [9.58] years; 16 females) with mean (SD) weight of 99.43 (21.89) kg at baseline were included. There was significant improvement in ALT (mean ± SD) from baseline of 59.54 ± 17.02 IU/L to 49.50 ± 11.72 IU/L and 48.42 ± 13.22 IU/L at 6 and 12 months (p = 0.001). Mean (SD) NFS was significantly improved from 0.228 (1.00) at baseline to -0.202 (1.16) and -0.552 (1.08) at 6 and 12 months (p 0.001). Mean (SD) HSI, FIB-4, and APRI scores significantly reduced from baseline to 6 and 12 months (p = 0.001). There was 18.07% total body weight loss at 12 months, with significant improvement in HbA1c. There were no major adverse events. CONCLUSION: ESG is a safe and effective treatment option for patients with NAFLD and obesity causing significant weight loss. Rigorous randomized trials are required to incorporate ESG in NAFLD treatment algorithm.

Long-term Outcomes of Per-oral Endoscopic Myotomy in Spastic Esophageal Motility Disorders: A Large, Single-Center Study.

BACKGROUND AND AIMS: Spastic esophageal motility disorders (SEMD) are a rare group of motility disorders including type III achalasia, distal esophageal spasm (DES), and Jackhammer esophagus (JHE). Limited data suggest that per-oral endoscopic myotomy (POEM) may be effective in these disorders. In this study, we aimed to evaluate the long-term outcomes of POEM in SEMD. METHODS: The data of patients with SEMD who underwent POEM (January 2013 to December 2019) were analyzed, retrospectively. The following outcomes were recorded: POEM procedure details, technical and clinical success, adverse events, and gastroesophageal reflux disease (GERD). Clinical success was classified as immediate (<1 y), short-term (1 to 3 y), medium term (3 to 5 y), and long-term (>5 y). RESULTS: A total of 1115 POEM procedures were performed during the study period for achalasia and nonachalasia spastic motility disorders. POEM was performed for SEMD in 74 (6.6%) patients including type III in 53, DES in 11, and JHE in 10 patients. Technical success was achieved in all the patients. The median follow-up for the entire group was 47.5 months (range: 2 to 77 mo). Clinical success at short-term (1 to 3 y) and long-term follow-up (>5 y) was attained in 85.2% and 82.6% patients, respectively. There was no significant difference in the clinical success between type III achalasia and JHE/DES. Mild and moderate adverse events were recorded in 21 (28.4%) cases. GERD was detected in 23 (56.1%) patients with 24-hour pH study. Erosive esophagitis and symptomatic GERD were found in 36 (48.6%) and 16 (21.6%) patients, respectively. CONCLUSIONS: POEM is a safe, effective, and durable treatment modality for spastic motility disorders of the esophagus. However, GERD is found in about half of the patients mandating close monitoring after POEM.

Comparison of Short Versus Long Esophageal Myotomy in Cases With Idiopathic Achalasia: A Randomized Controlled Trial.

BACKGROUND/AIMS: Per-oral endoscopic myotomy (POEM) is an established treatment for achalasia. The technique of POEM is still evolving and the impact of length of esophageal myotomy on the outcomes of POEM is not known. In this study, we aim to compare the outcomes of short (3 cm) versus long (6 cm and above) esophageal myotomy in patients undergoing POEM for achalasia cardia. METHODS: Consecutive patients with idiopathic achalasia (type I and II) were randomized to receive short (3 cm) or long esophageal myotomy (≥ 6 cm). Both groups were compared for clinical success, operative time, adverse events, and gastroesophageal reflux disease (GERD). RESULTS: Seventy-one consecutive patients with type I and II achalasia underwent POEM with short (n = 34) or long (n = 37) esophageal myotomy techniques. Mean length of esophageal myotomy in short and long groups was 2.76 ± 0.41 and 7.97 ± 2.40, respectively (P < 0.001). Mean operative time was significantly shorter in short myotomy group (44.03 ± 13.78 minutes and 72.43 ± 27.28 minutes, P < 0.001). Clinical success was comparable in both arms at 1-year (Eckardt score 0.935 ± 0.929 vs 0.818 ± 0.983, P = 0.627). Improvement in objective parameters including integrated relaxation pressure and barium column height at 5 minutes was similar in both groups. GERD was detected in 50.88% patients with no significant difference in short and long myotomy groups (44.44% vs 56.67%, P = 0.431). CONCLUSIONS: A short esophageal myotomy is non-inferior to long myotomy with regards to clinical success, adverse events, and GERD in cases with type I and II achalasia. Reduced operating duration favors short esophageal myotomy in these patients.

Gastroesophageal reflux after per-oral endoscopic myotomy is frequently asymptomatic, but leads to more severe esophagitis: A case-control study.

BACKGROUND AND AIM: The incidence of gastroesophageal reflux disease (GERD) is high after per-oral endoscopic myotomy (POEM). GERD after POEM may be qualitatively different from GERD in patients without motility disorders. In this study, we aimed to analyze and compare different aspects of GERD between patients with post-POEM GERD and nonachalasia GERD. METHODS: The data of patients with GERD after POEM (January 2018 to June 2019) were compared with that of a control group (nonachalasia GERD group), which included patients presenting with typical reflux symptoms without associated major motility disorders. Patients with lower esophageal sphincter pressure lower than 10 mmHg were excluded from the study. GERD was evaluated at 3 months after POEM. Esophageal acid exposure time higher than 4.2% was used to define GERD. The primary outcome of the study was comparison of GERD-related quality of life and reflux symptom severity between the two groups. In addition, the severity of erosive esophagitis and reflux-symptom association were also recorded in the two groups. RESULTS: A total of 100 patients were included in the study, with 50 patients in each group (post-POEM GERD vs. controls). The baseline parameters were comparable between the two groups. Median interquartile range of GERD-related quality of life score was significantly lower in the post-POEM group (11 [0-23.3] versus 34 [24-44]; p < 0.001). The post-POEM GERD group had significantly lower median heartburn (6.0 [0-16.3] versus 15.5 [7.5-24.8]; p = 0.001) and regurgitation scores (0 [0-6.0] versus 20.0 [12.3-25.0]; p < 0.001). Erosive esophagitis was more frequent in the post-POEM group (28 [56%] versus 10 [20.4%], p = 0.001). Only three (6%) patients in the post-POEM group had a positive reflux-symptom association as compared with 28 (56%) patients in the control group (p < 0.001). CONCLUSION: In selected patients with pH positive GERD after POEM, the symptoms are milder and reflux-symptom association is poor in spite of more severe esophagitis as compared with controls.

Endoscopic submucosal dissection and tunneling procedures using a novel all-in-one bipolar device.

Background and study aims Recent innovations in devices and techniques have revolutionized the field of endoscopic resection procedures. In this study, we evaluated the safety and feasibility of endoscopic submucosal dissection and tunneling procedures with a novel, multipurpose bipolar device. Patients and methods Data from consecutive patients who underwent per-oral endoscopic myotomy (POEM), submucosal tunneling endoscopic resection (STER), and endoscopic submucosal dissection (ESD) using a novel bipolar device (December 2019 to February 2020) were analyzed retrospectively. Procedure duration, technical success, and adverse events (AEs) were recorded. Results A total of 10 procedures were performed using the novel bipolar device during the study period. The procedures included POEM (n = 7), STER for esophageal sub-epithelial tumor (n = 1), ESD for rectal polyp (n = 1), and gastric neuroendocrine tumor (n = 1). POEM was successfully completed in all patients. In patients who underwent STER and ESD, en-bloc resection was achieved in all. Mean procedure time for submucosal tunneling procedures (POEM and STER) was 59.12 ±â€Š31.12 minutes. The procedures were completed without the requirement for exchange of accessories in eight cases (80 %). There were no major AEs. Mild and moderate AEs occurred during POEM and included capno-peritoneum (n = 1), retroperitoneal CO 2 (n = 1), and empyema (n = 1). Conclusion ESD and tunneling procedures can be safely performed without the need for exchange of accessories using a novel bipolar device. Randomized comparison with conventional knives isrequired to confirm the utility of this device.

Fluid type and volume reduce risk of post-ERCP pancreatitis and length of hospital stay in high-risk patients: a secondary analysis of the INDIEH trial.

Background and study aims Impact of intravenous fluid administration on prophylaxis against post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been rigorously evaluated among patients at high-risk for PEP. Patients and methods Effect of volume and type of fluid administered on PEP incidence was studied through a secondary analysis of high-risk patients who underwent endoscopic retrograde cholangopancreatography (ERCP) as a part of a randomized controlled trial in which all patients received rectal indomethacin. Periprocedural fluid was defined as fluid infused during and after ERCP. Results A total 960 patients were randomized during the trial, of whom 476 (49.6 %) received periprocedural fluids (mean volume = 1245 mL [±â€Š629]). There was a trend towards a lower incidence of PEP in patients who received periprocedural fluid vs. those who did not (5.2 % vs. 8.0 %, P  = 0.079). Among those receiving fluids, those who did not develop PEP received a higher mean volume of fluid vs. who developed PEP (1012 ±â€Š725 mL vs. 752 ±â€Š783 mL, P  = 0.036). Among 174 patients (37 %) who received LR, patients who did not develop PEP received a higher mean volume of LR vs. those who developed PEP (570 ±â€Š559 mL vs. 329 ±â€Š356 mL, P  = 0.006). Length of hospital stay decreased as the volume of periprocedural volume administration increased (r = 0.16, P  < 0.001). Conclusion Higher fluid volume and lactated Ringer's use during the periprocedural period was associated with a decreased risk of PEP and length of hospital stay beyond rectal indomethacin in high risk patients.

Gastroesophageal reflux disease after peroral endoscopic myotomy is unpredictable, but responsive to proton pump inhibitor therapy: a large, single-center study.

BACKGROUND: Gastroesophageal reflux disease (GERD) is an important concern after peroral endoscopic myotomy (POEM). However, there are limited data on the risk factors for post-POEM GERD and its responsiveness to proton pump inhibitors (PPIs). In this study, we aimed to analyze the variables affecting the occurrence of GERD and its response to PPI therapy. METHODS: Consecutive patients with idiopathic achalasia who underwent POEM (December 2016 to January 2018) were evaluated for GERD using 24-hour pH impedance, esophagogastroduodenoscopy (EGD), and symptoms. Multivariate analysis was performed to identify the variables affecting the incidence of post-POEM GERD. RESULTS: A total of 209 patients with esophageal motility disorders, including 194 patients with non-sigmoid achalasia, underwent POEM during the study period. Comprehensive evaluation of GERD was completed on 167 patients (86.1 %): 47.3 % women with a mean (standard deviation) age of 41 (14.42) years and body mass index of 22.2 (3.89) kg/m2; the majority (70.7 %) were treatment naïve. A high DeMeester score (> 14.72), reflux esophagitis, and symptomatic GERD were identified in 47.9 %, 41.9 %, and 29.3 % of patients, respectively. On logistic regression analysis, type of achalasia, technique of POEM (anterior vs. posterior), pre- or post-POEM esophageal manometry variables, and patient characteristics were not associated with post-POEM GERD. Erosive esophagitis responded to PPI therapy in the majority of patients (81.4 %). CONCLUSION: The incidence of GERD is high after POEM. Most of the reflux esophagitis is mild and responsive to PPI therapy. There are no procedural or patient-related variables that appear to affect the incidence of post-POEM GERD.

A Randomized Trial of Topical Epinephrine and Rectal Indomethacin for Preventing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-Risk Patients.

INTRODUCTION: Rectal indomethacin and topical spray of epinephrine have separately shown efficacy in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) in randomized controlled trials. We hypothesized that the combination of indomethacin and topical spray of epinephrine on the duodenal papillae would further reduce PEP than when indomethacin was used alone. METHODS: We conducted a comparative effectiveness, multicenter, double-blinded, randomized trial of rectal indomethacin alone vs a combination of rectal indomethacin and topical spray of epinephrine for the prevention of PEP in high-risk patients. The primary outcome was the incidence of PEP and the secondary outcome was the severity of PEP. A 2-tailed Fisher's exact test was used to analyze the difference in the proportion of patients with PEP in the indomethacin alone vs the combination group. RESULTS: A total of 960 patients (mean age 52.33 ± 14.96 years; 551 [57.4%] females) were randomized and 959 completed follow-up. The baseline demographic and clinical characteristics were similar between the 2 groups. Women <50 years of age (25.4%) and difficult cannulation (84.9%) were the most common PEP risk factors. The incidence of PEP was 6.4% in the indomethacin alone group (n = 482) compared to 6.7% in the combination group (n = 477; P = 0.87). Severe PEP was found in 5 (12%) and 7 (16%) patients in the indomethacin alone and combination groups, respectively (P = 0.88). The overall mortality was 0.6%, which was unrelated to the primary outcome. CONCLUSIONS: The combination of rectal indomethacin and topical spray of epinephrine does not reduce the incidence of PEP compared to rectal indomethacin alone in high-risk patients; https://clinicaltrials.gov/ct2/show/NCT02116309.