Incidence, severity, and mortality of post-ERCP pancreatitis: an updated systematic review and meta-analysis of 145 randomized controlled trials.

BACKGROUND AND AIMS: The incidence, severity, and mortality of post-ERCP pancreatitis (PEP) largely remain unknown with changing trends in ERCP use, indication, and techniques. We sought to determine the incidence, severity, and mortality of PEP in consecutive and high-risk patients based on a systemic review and meta-analysis of patients in placebo and no-stent arms of randomized control trials (RCTs). METHODS: The MEDLINE, Embase, and Cochrane databases were searched from the inception of each database to June 2022 to identify full-text RCTs evaluating PEP prophylaxes. The incidence, severity, and mortality of PEP from the placebo or no-stent arms of RCTs were recorded for consecutive and high-risk patients. A random-effects meta-analysis for a proportions model was used to calculate PEP incidence, severity, and mortality. RESULTS: One hundred forty-five RCTs were found with 19,038 patients in the placebo or no-stent arms. The overall cumulative incidence of PEP was 10.2% (95% confidence interval [CI], 9.3-11.3), predominantly among the academic centers conducting such RCTs. The cumulative incidences of severe PEP and mortality were .5% (95% CI, .3-.7) and .2% (95% CI, .08-.3), respectively, across 91 RCTs with 14,441 patients. The cumulative incidences of PEP and severe PEP were 14.1% (95% CI, 11.5-17.2) and .8% (95% CI, .4-1.6), respectively, with a mortality rate of .2% (95% CI, 0-.3) across 35 RCTs with 3733 patients at high risk of PEP. The overall trend for the incidence of PEP among patients randomized to placebo or no-stent arms of RCTs has remained unchanged from 1977 to 2022 (P = .48). CONCLUSIONS: The overall incidence of PEP is 10.2% but is 14.1% among high-risk patients based on this systematic review of placebo or no-stent arms of 145 RCTs; this rate has not changed between 1977 and 2022. Severe PEP and mortality from PEP are relatively uncommon.

Role of functional luminal imaging probe in the management of postmyotomy clinical failure.

BACKGROUND AND AIMS: A small percentage of patients with esophageal dysmotility disorders (EDDs) fail to improve or relapse after management by laparoscopic Heller myotomy (LHM) and peroral endoscopic myotomy (POEM). In this study, we aimed to describe the role of functional luminal imaging probe (FLIP) in identifying patients who might benefit from lower esophageal sphincter (LES)-directed retreatment. METHODS: This was a retrospective study at 6 tertiary care centers (United States, 4; Europe, 1; Asia, 1) between January 2015 and April 2021 involving patients with prior failed myotomy. The primary outcome was the impact of the use of FLIP on the management of patients with prior failed myotomy. RESULTS: One hundred twenty-three patients (62 women [50%]; mean age, 53 ± 21.1 years) who underwent LHM (n = 53, 43%) or POEM (n = 70, 57%) for the management of achalasia (n = 98) or other EDDs (n = 25) had clinical failure at a median time of 10.8 months (interquartile range, .8-17.3) postprocedure. Twenty-nine patients had apposing "abnormal" diagnoses in terms of integrated relaxation pressure (IRP) >15 mm Hg on HRM and distensibility index (DI) <2.8 mm2/mm Hg on FLIP, with ultimate change in management noted in 15 patients (10 directed toward conservative management, 5 directed toward LES-directed retreatment). The impact of FLIP on both diagnosis and management was noted in 15 of 29 patients (52%). In the subgroup analysis of 44 patients who underwent LES-directed retreatment, clinical success was highest among patients with both abnormal IRP and DI (21/25 [84%]) versus patients with only abnormal IRP (8/14 [57%]) or only abnormal DI (3/5 [60%], P = .04), with DI at 40-mL distension volume on FLIP identified as an independent predictor of clinical success (odd ratio, 1.51; 95% confidence interval, 1.02-2.1; P = .03). CONCLUSIONS: The finding of this study further suggests the important role of using FLIP in addition to HRM in evaluating patients with clinical failure postmyotomy.

Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: results from an international prospective trial.

OBJECTIVE: Although gastric per-oral endoscopic myotomy (G-POEM) is considered a promising technique for the management of refractory gastroparesis, high-quality evidence is limited. We prospectively investigated the efficacy and safety of G-POEM in unselected patients with refractory gastroparesis. DESIGN: In five tertiary centres, patients with symptomatic gastroparesis refractory to standard medical therapy and confirmed by impaired gastric emptying were included. The primary endpoint was clinical success, defined as at least one score decrease in Gastroparesis Cardinal Symptom Index (GCSI) with ≥25% decrease in two subscales, at 12 months. GCSI Score and subscales, adverse events (AEs) and 36-Item Short Form questionnaire of quality of life were evaluated at baseline and 1, 3, 6 and 12 months after G-POEM. Gastric emptying study was performed before and 3 months after the procedure. RESULTS: Of 80 enrolled patients, 75 patients (94%) completed 12-month follow-up. Clinical success at 12 months was 56% (95% CI, 44.8 to 66.7). GCSI Score (including subscales) improved moderately after G-POEM (p<0.05). In a regression model, a baseline GCSI Score >2.6 (OR=3.23, p=0.04) and baseline gastric retention >20% at 4 hours (OR=3.65, p=0.03) were independent predictors of clinical success at 12 months, as was early response to G-POEM at 1 month after therapy (OR 8.75, p<0.001). Mild procedure-related AEs occurred in 5 (6%) patients. CONCLUSION: G-POEM is a safe procedure, but showed only modest overall effectiveness in the treatment of refractory gastroparesis. Further studies are required to identify the best candidates for G-POEM; unselective use of this procedure should be discouraged. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry NCT02732821.

Zenker's peroral endoscopic myotomy, or flexible or rigid septotomy for Zenker's diverticulum: a multicenter retrospective comparison.

BACKGROUND: Treatment of Zenker's diverticulum has evolved from open surgery to endoscopic techniques, including flexible and rigid endoscopic septotomy, and more recently, peroral endoscopic myotomy (Z-POEM). This study compared the effectiveness of flexible and rigid endoscopic septotomy with that of Z-POEM. METHODS: Consecutive patients who underwent endoscopic septotomy (flexible/rigid) or Z-POEM for Zenker's diverticulum between 1/2016 and 9/2019 were included. Primary outcomes were clinical success (decrease in Dakkak and Bennett dysphagia score to ≤ 1), clinical failure, and clinical recurrence. Secondary outcomes included technical success and rate/severity of adverse events. RESULTS: 245 patients (110 females, mean age 72.63 years, standard deviation [SD] 12.37 years) from 12 centers were included. Z-POEM was the most common management modality (n = 119), followed by flexible (n = 86) and rigid (n = 40) endoscopic septotomy. Clinical success was 92.7 % for Z-POEM, 89.2 % for rigid septotomy, and 86.7 % for flexible septotomy (P = 0.26). Symptoms recurred in 24 patients (15 Z-POEM during a mean follow-up of 282.04 [SD 300.48] days, 6 flexible, 3 rigid [P = 0.47]). Adverse events occurred in 30.0 % rigid septotomy patients, 16.8 % Z-POEM patients, and 2.3 % flexible septotomy patients (P < 0.05). CONCLUSIONS: There was no difference in outcomes between the three treatment approaches for symptomatic Zenker's diverticulum. Rigid endoscopic septotomy was associated with the highest rate of complications, while flexible endoscopic septotomy appeared to be the safest. Recurrence following Z-POEM was similar to flexible and rigid endoscopic septotomy. Prospective studies with long-term follow-up are required.

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.

The learning curve for transoral incisionless fundoplication.

Background and study aims Transoral incisionless fundoplication (TIF) is a safe and effective minimally invasive endoscopic technique for treating gastroesophageal reflux disease (GERD). The learning curve for this technique has not been reported. We studied the learning curve for TIF when performed by a gastroenterologist by identifying the threshold number of procedures needed to achieve consistent technical success or proficiency (consistent creation of TIF valve ≥ 270 degrees in circumference, ≥ 2 cm long) and efficiency after didactic, hands-on and case observation experience. Patients and methods We analyzed prospectively collected data from patients who had TIF performed by a single therapeutic endoscopist within 17 months after basic training. We determined thresholds for procedural learning using cumulative sum of means (CUSUM) analysis to detect changes in achievement rates over time. We used breakpoint analysis to calculate procedure metrics related to proficiency and efficiency. Results A total of 69 patients had 72 TIFs. The most common indications were refractory GERD (44.7 %) and proton pump inhbitor intolerance (23.6 %). Proficiency was achieved at the 18 th to 20 th procedure. The maximum efficiency for performing a plication was achieved after the 26 th procedure, when mean time per plication decreased to 2.7 from 5.1 minutes (P < 0.0001). TIF procedures time varied until the 44 th procedure, after which it decreased significantly from 53.7 minutes to 39.4 minutes (P < 0.0001). Conclusions TIF can be safely, successfully, and efficiently performed in the endoscopy suite by a therapeutic endoscopist. The TIF learning curve is steep but proficiency can be achieved after a basic training experience and 18 to 20 independently performed procedures.

Single session per oral endoscopic myotomy and trans oral incisionless fundoplication - can we prevent reflux in patients with achalasia?

Background and study aims The rate of gastroesophageal reflux disease (GERD) after per oral endoscopic myotomy (POEM) is concerning. Endoscopic anti-reflux methods, such as Trans Oral Incisionless Fundoplication (TIF), are crucial for the long-term success of POEM, especially if they can be performed in the same session. Methods We completed a proof-of-concept canine pilot study (n = 6) to assess safety and feasibility of POEM and TIF in a single session (POEM-TIF). Subsequently, POEM-TIF was also performed in patients with achalasia (n = 5). Herein, we report on the safety, technical and clinical success of the first-in-human cases with symptom follow-up at 1, 3 and 6 months and pH testing at 6 months. Results POEM was completed successfully in six canines (3 anterior and 3 posterior myotomies), followed by TIF in the same session. Necropsy and extensive testing demonstrated no evidence of mucosal injury and no leaks. The reconstructed valve was 220 to 240 degrees, 3 to 4 cm in length, and resulted in concomitant esophageal lengthening (2-5 cm). Using similar principles, the first-in-human cases were performed without intraprocedural or delayed adverse events. pH testing at 6 months showed that four of five patients had no evidence of GERD (DeMeester > 14.72), and in one case, there was evidence of esophagitis. Conclusions Single session POEM-TIF appears to be safe and feasible. Early clinical human data suggests that it may be able to reduce post POEM GERD, however the additional secondary benefits such as lengthening and straightening of the esophagus, may prove to be equally important for the long-term success of POEM.

Multicenter experience with digital single-operator cholangioscopy in pregnant patients.

Background and study aims The use of fluoroscopy during pregnancy should be minimized given that a clear-cut safe radiation dose in pregnancy is unknown. The role of digital single-operator cholangioscopy (D-SOC) as an alternative to standard enodoscopic retrograde cholangiopancreatography (ERCP) in pregnant patients has not been comprehensively studied. This study assessed 1 Technical success defined as performance of ERCP with D-SOC without the use of fluoroscopy in pregnant patients; 2 safety of D-SOC in pregnancy; and 3 maternal and neonatal outcomes after D-SOC during/after pregnancy. Patients and methods This was an international, multicenter, retrospective study at 6 tertiary centers. Pregnant patients who underwent D-SOC for the treatment of bile duct stones and/or strictures were included. Results A total of 10 patients underwent D-SOC. Indications for ERCP were choledocholithiasis, strictures, previous stent removal, and choledocholithiasis/stent removal. Bile duct cannulation without fluoroscopy was achieved in 10 of 10 patients (100 %). Moreover, 50 % of patients (5/10) completed a fluoroless ERCP with D-SOC. Mean fluoroscopy dose and fluoroscopy time were 3.4 ±â€Š7.2 mGy and 0.5 ±â€Š0.8 min, respectively. One case of mild bleeding and one case of moderate post-ERCP pancreatitis occurred. The mean gestational age at delivery was 36.2 ±â€Š2.6 weeks. Median birth weight was 2.5 kg [IQR: 2.2-2.8]. No birth defects were noted. Conclusion ERCP guided by D-SOC appears to be a feasible and effective alternative to standard ERCP in pregnant patients. It enables avoidance of radiation in half of cases.

Guidelines on management of pancreatic cysts detected in high-risk individuals: An evaluation of the 2017 Fukuoka guidelines and the 2020 International Cancer of the Pancreas Screening (CAPS) consortium statements.

BACKGROUND: Objectives: Pancreatic cysts are frequently detected in high-risk individuals (HRI) undergoing surveillance for pancreatic cancer. The International Cancer of the Pancreas Screening (CAPS) Consortium developed consensus recommendations for surgical resection of pancreatic cysts in HRI that are similar to the Fukuoka guidelines used for the management of sporadic cysts. We compared the performance characteristics of CAPS criteria for pancreatic cyst management in HRI with the Fukuoka guidelines originally designed for the management of cysts in non-HRI. METHODS: Using prospectively collected data from CAPS studies, we determined for each patient with resected screen-detected cyst(s) whether Fukuoka guidelines or CAPS consensus statements would have recommended surgery. We compared sensitivity, specificity, PPV, NPV, and Receiver Operator Characteristics (ROC) curves of these guidelines at predicting the presence of high-grade dysplasia or invasive cancer in pancreatic cysts. RESULTS: 356/732 HRI had ≥ one pancreatic cyst detected; 24 had surgery for concerning cystic lesions. The sensitivity, specificity, PPV, and NPV for the Fukuoka criteria were 40%, 85%, 40%, and 85%, while those of the CAPS criteria were 60%, 85%, 50%, 89%, respectively. ROC curve analyses showed no significant difference between the Fukuoka and CAPS criteria. CONCLUSIONS: In HRI, the CAPS and Fukuoka criteria are moderately specific, but not sufficiently sensitive for detecting advanced neoplasia in cystic lesions. New approaches are needed to guide the surgical management of cystic lesions in HRI.

Impedance planimetry values for predicting clinical response following peroral endoscopic myotomy.

BACKGROUND: There is growing interest in developing impedance planimetry as a tool to enhance the clinical outcomes for endoscopic and surgical management of achalasia. The primary aim of this study was to determine whether impedance planimetry measurements can predict clinical response and reflux following peroral endoscopic myotomy (POEM). METHODS: A multicenter cohort study of patients with achalasia undergoing POEM was established from prospective databases and retrospective chart reviews. Patients who underwent impedance planimetry before and after POEM were included. Clinical response was defined as an Eckardt score of ≤ 3. Tenfold cross-validated area under curve (AUC) values were established for the different impedance planimetry measurements associated with clinical response and reflux development. RESULTS: Of the 290 patients included, 91.7 % (266/290) had a clinical response and 39.4 % (108/274) developed reflux following POEM. The most predictive impedance planimetry measurements for a clinical response were: percent change in cross-sectional area (%ΔCSA) and percent change in distensibility index (%ΔDI), with AUCs of 0.75 and 0.73, respectively. Optimal cutoff values for %ΔCSA and %ΔDI to determine a clinical response were a change of 360 % and 272 %, respectively. Impedance planimetry values were much poorer at predicting post-POEM reflux, with AUCs ranging from 0.40 to 0.62. CONCLUSION: Percent change in CSA and distensibility index were the most predictive measures of a clinical response, with a moderate predictive ability. Impedance planimetry values for predicting reflux following POEM showed weak predictive capacity.

Endoscopic ultrasound-directed transgastric ERCP (EDGE): a retrospective multicenter study.

BACKGROUND: Endoscopic ultrasound-directed transgastric endoscopic retrograde cholangiopancreatography (ERCP; EDGE) is an alternative to enteroscopy- and laparoscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy. Although short-term results are promising, the long-term outcomes are not known. The aims of this study were: (1) to determine the rates of long-term adverse events after EDGE, with a focus on rates of persistent gastrogastric or jejunogastric fistula; (2) to identify predictors of persistent fistula; (3) to assess the outcomes of endoscopic closure when persistent fistula is encountered. METHODS: This was a multicenter retrospective study involving 13 centers between February 2015 and March 2019. Adverse events were defined according to the ASGE lexicon. Persistent fistula was defined as an upper gastrointestinal series or esophagogastroduodenoscopy showing evidence of fistula. RESULTS: 178 patients (mean age 58 years, 79 % women) underwent EDGE. Technical success was achieved in 98 % of cases (175/178), with a mean procedure time of 92 minutes. Periprocedural adverse events occurred in 28 patients (15.7 %; mild 10.1 %, moderate 3.4 %, severe 2.2 %). The four severe adverse events were managed laparoscopically. Persistent fistula was diagnosed in 10 % of those sent for objective testing (9/90). Following identification of a fistula, 5 /9 patients underwent endoscopic closure procedures, which were successful in all cases. CONCLUSIONS: The EDGE procedure is associated with high clinical success rates and an acceptable risk profile. Persistent fistulas after lumen-apposing stent removal are uncommon, but objective testing is recommended to identify their presence. When persistent fistulas are identified, endoscopic treatment is warranted, and should be successful in closing the fistula.

Assessment of the learning curve for EUS-guided gastroenterostomy for a single operator.

BACKGROUND AND AIMS: EUS-guided gastroenterostomy (EUS-GE) is increasingly used as an alternative to surgery and enteral stent placement to manage gastric outlet obstruction (GOO). However, no data are available on the learning curve (LC) for EUS-GE. Defining the LC is necessary to create adequate subspecialty training programs and quality assurance. METHODS: This study is a retrospective analysis of a prospectively maintained dataset of patients who underwent EUS-GE at 1 tertiary referral center. Primary outcome was the LC for EUS-GE defined by the number of cases needed to achieve proficiency and mastery using cumulative sum (CUSUM) analysis. Moving average graphs and sequential time-block analysis were also performed to assess procedural time. Secondary outcomes included efficacy and safety of EUS-GE. RESULTS: Eighty-seven consecutive patients underwent EUS-GE, mostly for malignant GOO. For consistency, 14 patients were excluded from analysis (noncautery-assisted EUS-GE, 11; surgical anatomy, 3). The same endoscopist performed all procedures using the same freehand technique. Technical success was achieved in 68 of 73 patients (93%). Immediate adverse events occurred in 4 patients (5.5%), whereas late adverse events occurred only in 1 patient (1%), all managed conservatively or endoscopically. All immediate adverse events occurred during the first 39 cases. Clinical success (defined as resuming at least an oral liquid diet within a week) was achieved in 97% of patients. The mean procedural time was 36 minutes (standard deviation, 24). Evaluation of the CUSUM curve revealed that 25 cases were needed to achieve proficiency and 40 cases to achieve mastery. These results were confirmed with the average moving curve and sequential time-block analysis. CONCLUSIONS: We report, for the first time, data on the LC for EUS-GE. About 25 procedures can be considered as the threshold to achieve proficiency and about 40 cases are needed to reach mastery of the technique.

Management of patients after failed peroral endoscopic myotomy: a multicenter study.

BACKGROUND: Although peroral endoscopic myotomy (POEM) is highly effective for the management of achalasia, clinical failures may occur. The optimal management of patients who fail POEM is not well known. This study aimed to compare the outcomes of different management strategies in patients who had failed POEM. METHODS: This was an international multicenter retrospective study at 16 tertiary centers between January 2012 and November 2019. All patients who underwent POEM and experienced persistent or recurrent symptoms (Eckardt score > 3) were included. The primary outcome was to compare the rates of clinical success (Eckardt score ≤ 3) between different management strategies. RESULTS : 99 patients (50 men [50.5 %]; mean age 51.4 [standard deviation (SD) 16.2]) experienced clinical failure during the study period, with a mean (SD) Eckardt score of 5.4 (0.3). A total of 29 patients (32.2 %) were managed conservatively and 70 (71 %) underwent retreatment (repeat POEM 33 [33 %], pneumatic dilation 30 [30 %], and laparoscopic Heller myotomy (LHM) 7 [7.1 %]). During a median follow-up of 10 (interquartile range 3 - 20) months, clinical success was highest in patients who underwent repeat POEM (25 /33 [76 %]; mean [SD] Eckardt score 2.1 [2.1]), followed by pneumatic dilation (18/30 [60 %]; Eckardt score 2.8 [2.3]), and LHM (2/7 [29 %]; Eckardt score 4 [1.8]; P = 0.12). A total of 11 patients in the conservative group (37.9 %; mean Eckardt score 4 [1.8]) achieved clinical success. CONCLUSION : This study comprehensively assessed an international cohort of patients who underwent management of failed POEM. Repeat POEM and pneumatic dilation achieved acceptable clinical success, with excellent safety profiles.

Management of adverse events of EUS-directed transgastric ERCP procedure.

BACKGROUND AND AIMS: Accessing the pancreatobiliary region in patients with a history of Roux-en-Y gastric bypass (RYGB) can be challenging. Traditionally, techniques such as percutaneous biliary drainage, enteroscopy-assisted ERCP, and laparoscopy-assisted ERCP have been used. However, each technique has its limitations. EUS-directed transgastric ERCP (EDGE) using a lumen-apposing metal stent (LAMS) has emerged as a novel endoscopic technique for ERCP in patients who have undergone RYGB. The aim of this case series was to highlight LAMS-related shortcomings and adverse events during the periprocedural period. METHODS: This was a retrospective review of 4 patients with RYGB anatomy who underwent EDGE for the management of pancreaticobiliary disease and experienced LAMS-related adverse events. Techniques for managing and avoiding these events are discussed. RESULTS: Four patients underwent EDGE with both technical and clinical success. Slight LAMS migration with partial mucosal overgrowth was encountered in 1 case and was managed by LAMS removal. A large, bleeding, distal marginal ulcer after the EDGE procedure was encountered in the second case and was managed with proton pump inhibitor and removal of the LAMS, with fistula treatment with argon plasma coagulation used to enhance closure. The third case was complicated by moderate intraprocedural bleeding after LAMS dilation, which was managed by applying balloon tamponade and placing a through-the-scope esophageal stent across the LAMS. Last, preferential food passage to the excluded stomach was noted in the fourth case and resulted in symptomatic distention. The symptomatic distention was managed by another de novo jejunogastrostomy using a LAMS for drainage. CONCLUSIONS: Despite its feasibility and acceptable safety profile, the use of LAMSs during EDGE could be associated with several procedure-specific adverse events, which can be avoided or managed endoscopically with no further consequence.

Treatment experience with a novel 30-mm hydrostatic balloon in esophageal dysmotility: a multicenter retrospective analysis.

BACKGROUND AND AIMS: The newest addition in the management of achalasia and esophagogastric junction outflow obstruction (EGJOO) is a 30-mm hydrostatic balloon dilator that uses impedance planimetry technology. It allows for the measurement of the diameter and cross-sectional area to determine effective dilation. We aimed to (1) determine the clinical success (defined as a decrease in Eckardt score to ≤3) in the treatment of esophageal motility disorders and (2) report the safety (rate/severity of adverse events). METHODS: This retrospective multicenter study involved 4 centers. Patients with esophageal motility disorders who underwent hydrostatic balloon dilation between January 2015 and October 2018 were included. RESULTS: Fifty-one patients (mean age, 54.1 years; women, 49%) underwent hydrostatic dilation for achalasia (n = 37) or EGJOO (n = 14) during the study period. Forty-seven patients had a median baseline Eckardt score of 5 (range, 3-8; achalasia, n = 35, 6 [range, 3-8]; EGJOO, n = 12, 4 [range, 3.25-6.5]). Clinical success was achieved in 60% of cases (achalasia vs EGJOO: 68.4% vs 33.3%, P = .18). Dilation resulted in a significant decrease in the median Eckardt score from 5 (range, 3-8) to 1.5 (range, 1-4.75; P < .001). Patients with achalasia had a decrease in Eckardt score from 6 (range, 3-8) to 1 (range, 1-4; P < .001), whereas those with EGJOO experienced no significant change. One patient had mild postprocedure chest pain. CONCLUSIONS: The hydrostatic balloon dilator is a new tool in our armamentarium to treat esophageal motility disorders. This is the first multicenter study showing the device to be safe and moderately efficacious.

Long-term outcomes of per-oral endoscopic myotomy in achalasia patients with a minimum follow-up of 4†years: a multicenter study.

Background and study aims Per-oral endoscopic myotomy (POEM) is associated with a short-term clinical response of 82 % to 100 % in treatment of patients with achalasia. Data are limited on the long-term durability of the clinical response in these patients. The aim of this study was to determine the long-term outcomes of patients undergoing POEM for management of achalasia. Methods This was a retrospective multicenter cohort study of consecutive patients who underwent POEM for management of achalasia. Patients had a minimum of 4 years follow-up. Clinical response was defined by an Eckardt score ≤ 3. Results A total of 146 patients were included from 11 academic medical centers. Mean (±â€ŠSD) age was 49.8 (±â€Š16) years and 79 (54 %) were female. The most common type of achalasia was type II, seen in 70 (47.9 %) patients, followed by type I seen in 41 (28.1 %) patients. Prior treatments included: pneumatic dilation in 29 (19.9 %), botulinum toxin injection in 13 (8.9 %) and Heller myotomy in seven patients (4.8 %). Eight adverse events occurred (6 mucosotomies, 2 pneumothorax) in eight patients (5.5 %). Median follow-up duration was 55 months (IQR 49.9-60.6). Clinical response was observed in 139 (95.2 %) patients at follow-up of ≥ 48 months. Symptomatic reflux after POEM was seen in 45 (32.1 %) patients, while 35.3 % of patients were using daily PPI at 48 months post POEM. Reflux esophagitis was noted in 16.8 % of patients who underwent endoscopy. Conclusion POEM is a durable and safe procedure with an acceptably low adverse event rate and an excellent long-term clinical response.