Comparative Analysis of Open and Closed Sphincterotomy for the Treatment of Chronic Anal Fissure: Safety and Efficacy Evaluation.

BACKGROUND Chronic anal fissure is a common condition that causes pain and discomfort and has a significant impact on quality of life. When conservative management fails, surgical sphincterotomy can be successful. This retrospective study from a single center in Turkey included 188 patients with chronic anal fissures and aimed to compare outcomes from open and closed sphincterotomy. MATERIAL AND METHODS This retrospective study included 188 patients treated with lateral internal sphincterotomy (LIS) for chronic anal fissure between January 2015 and December 2021 in our hospital. Open LIS procedure was performed in 91 patients and closed LIS was performed in 97 patients. Demographic characteristics, postoperative complications, and recurrence were compared for these 2 methods. RESULTS Of the 188 patients included in the study, 47.9% were women and 52.1% were men. The mean age was 42.9 (20-84) years. In the open LIS group, recurrence occurred in 2 patients (2.19%), and no incontinence was observed. In the closed LIS group, recurrence occurred in 3 patients (3%; P=0.703), and incontinence developed in 5 patients (5.15%; P=0.035). CONCLUSIONS Comparing the 2 methods used in chronic anal fissure surgery, and considering the recurrence and risk of incontinence, the most feared outcome by the patient and surgeon, open LIS stands out as a superior technique, especially in young male patients.

Design and execution of sham-controlled endoscopic trials in acute pancreatitis: Lessons learned from the SHARP trial.

Using the ongoing NIDDK-funded multicenter randomized clinical trial, Sphincterotomy for Acute Recurrent Pancreatitis (SHARP) as an example, this article discusses the rationale and key aspects of study design that need to be considered when conducting a clinical trial of endoscopic therapy in acute pancreatitis. SHARP, the first trial using a sham ERCP in the placebo group, is designed to address a decades long controversy in clinical pancreatology, i.e. whether minor papilla sphincterotomy benefits patients with idiopathic acute recurrent pancreatitis who also have pancreas divisum. Although the trial has already enrolled and randomized over 5 times the number of subjects enrolled in the only randomized trial in this area published in 1992 (107 vs. 19), recruitment has been challenging and we are at ∼46% of target recruitment. The review discusses the challenges in the execution of the trial and strategies the SHARP team has used to address these, which investigators planning or considering treatment trials in pancreatitis may find helpful. It will also inform the general gastroenterologists the importance of discussing and referring potentially eligible subjects to centers participating in clinical trials. Developing evidence-based treatment will provide a solid scientific basis for physicians to recommend evidence-based treatments for pancreatitis.

Risk of post-sphincterotomy bleeding with antiplatelet and anticoagulant use: a propensity-matched analysis of the U.S. Collaborative Network.

BACKGROUND AND AIMS: GI bleeding after ERCP is a serious adverse event and most commonly occurs after endoscopic biliary and/or pancreatic sphincterotomy. Although the strength of available evidence for post-sphincterotomy GI bleeding risk is high for therapeutic warfarin and heparin, it remains unknown for antiplatelet agents like clopidogrel and prasugrel. We conducted a retrospective United States-based, propensity-matched cohort study to assess the risk of post-sphincterotomy bleeding in patients receiving anticoagulant (AC) and antiplatelet (APT) therapy. METHODS: We analyzed the U.S. Collaborative Network in the TriNetX platform through December 27, 2022, to include patients receiving APT and AC therapy who underwent ERCP within 7 days of hospitalization. One-to-one propensity score matching was performed. The primary outcome was the incidence of GI bleeding within 7 days of sphincterotomy. Secondary outcomes included need for blood transfusion, intensive care unit care, and all-cause mortality within 30 days of bleeding. RESULTS: Overall, 2806 patients (1806 in the AC cohort and 1000 in the APT cohort) underwent ERCP with sphincterotomy. One-to-one propensity score matching was performed for age, body mass index ≥30 kg/m2, gender, race, ethnicity, diabetes mellitus, nicotine dependence, presence and severity of chronic kidney disease, cirrhosis, and thrombocytopenia between the cohorts. Patients in both cohorts had an increased risk of post-sphincterotomy bleeding compared with matched control subjects (adjusted odds ratios of 3.6 [95% confidence interval, 2.58-5.06] and 2.2 [95% confidence interval, 1.43-3.56], respectively). Although heparin bridging therapy and concurrent use of aspirin did not further increase the risk of GI bleeding, resumption of AC within 24 hours' postprocedure did. Neither cohort of patients was at an increased risk for blood transfusion, intensive care unit care, or all-cause mortality. CONCLUSIONS: Our database analysis shows that patients receiving AC and APT therapy are at a higher risk of post-sphincterotomy bleeding compared with matched control subjects. An appropriate drug cessation period or alternative biliary decompression modalities may be used in these patients.

The effect of Trolox on the rabbit anal sphincterotomy repair.

INTRODUCTION: Fecal incontinence (FI) is caused by external anal sphincter injury. Vitamin E is a potential strategy for anal sphincter muscle repair via its antioxidant, anti-inflammatory, anti-fibrotic, and protective properties against myocyte loss. Thus, we aimed to evaluate the water-soluble form of vitamin E efficacy in repairing anal sphincter muscle defects in rabbits. METHODS: Twenty-one male rabbits were equally assigned to the intact (without any intervention), control (sphincterotomy), and Trolox (sphincterotomy + Trolox administration) groups. Ninety days after sphincterotomy, the resting and squeeze pressures were evaluated by manometry, and the number of motor units in the sphincterotomy site was calculated by electromyography. Also, the amount of muscle and collagen in the injury site was investigated by Mallory's trichrome staining. RESULTS: Ninety days after the intervention, the resting and squeeze pressures in the intact and Trolox groups were significantly higher than in the control group (P = 0.001). Moreover, the total collagen percentage of the sphincterotomy site was significantly lower in the Trolox group than in the control group (P = 0.002), and the total muscle percentage was significantly higher in the Trolox group compared to the control group (P = 0.001). Also, the motor unit number was higher in the Trolox group than in the control group (P = 0.001). CONCLUSION: Trolox administration in the rabbit sphincterotomy model can decrease the amount of collagen and increase muscle, leading to improved anal sphincter electromyography and manometry results. Therefore, Trolox is a potential treatment strategy for FI.

Comparison between Transpancreatic Sphincterotomy and Needle-Knife Precut in Difficult Cannulation of Endoscopic Retrograde Cholangiopancreatography: An Up-To-Date Meta-Analysis and Systematic Review.

BACKGROUND: Selective cannulation, which is essential for endoscopic retrograde cholangiopancreatography (ERCP), may be difficult. The aim of this study was to compare transpancreatic sphincterotomy (TPS) and needle-knife precut (NKP) in difficult cannulation during ERCP. METHODS: PubMed, Embase, Web of Science, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched for relevant studies from January 1990 to April 2022. A meta-analysis focusing on cannulation success and post-ERCP complications was performed using Review Manager. RESULTS: Seventeen eligible studies involving 2,340 patients were included. Our results showed that the TPS group had a higher cannulation success rate (odds ratio [OR] 0.48, 95% confidence interval [CI] 0.27-0.87, p = 0.02) and less bleeding (OR 1.94, 95% CI: 1.09-3.47, p = 0.03) compared with the NKP group. There was no significant difference between NKP and TPS in the rates of post-ERCP pancreatitis (OR 0.83, 95% CI: 0.59-1.18, p = 0.30), perforation (OR 2.04, 95% CI: 0.69-6.03, p = 0.20), and adverse events (OR 1.29, 95% CI: 0.94-1.77, p = 0.12). CONCLUSION: TPS appears to be associated with a higher cannulation success rate and less bleeding than those with NKP, with equal post-ERCP pancreatitis, perforation, and adverse event rates between TPS and NKP. Further large-scale trials are warranted to support our findings.

Chemical sphincterotomy in posthemorrhoidectomy pain relief: a meta-analysis.

PURPOSE: This study aims to evaluate the pain relief function of chemical sphincterotomy in patients undergoing haemorrhoid surgery and compare, through a meta-analysis, the different drugs used to treat this condition. METHODS: We conducted a search in databases including PubMed, EMBASE and Web of Science. The methodological quality was evaluated using the Revised Cochrane risk-of-bias tool for randomized trials (ROB2). The pain score was assessed using a visual analogue scale (VAS) on day 1, day 2, and day 7, and a meta-analysis was conducted based on the use of random effects models. In addition, the subgroup analysis was evaluated based on the kind of experimental drugs. Heterogeneity and publication bias were assessed. RESULTS: Fourteen studies with a total of 681 patients were included in this meta-analysis, and all studies were randomized controlled trials RCTs. Chemical sphincterotomy showed better pain relief function than placebo on day 1 (SMD: 1.16, 95% CI 0.52 to 1.80), day 2 (SMD: 2.12, 95% CI 1.37 to 2.87) and day 7 (SMD: 1.97, 95% CI 1.17 to 2.77) after surgery. In the subgroup meta-analysis, we found that different drugs for chemical sphincterotomy provided different pain relief. CONCLUSION: Chemical sphincterotomy effectively relieves pain after haemorrhoidectomy, and calcium channel blockers have the best effect.

ERCP in patients with prior sphincterotomy has a 50% lower rate of post-ERCP pancreatitis and fewer unplanned hospital admissions.

OBJECTIVES: ERCP is essential in managing pancreaticobiliary disease, with well-documented complications. Rates of clinically significant complications are about 10%, approximately half of which is related to post-ERCP pancreatitis (PEP). We aimed to quantify the effect of previous sphincterotomy on post-endoiscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). MATERIALS AND METHODS: Data were collated from a contemporaneously collected database of 2876 consecutive ERCP procedures of a single operator in a tertiary referral centre. Analysis was conducted using R software, and logistic regression models. RESULTS: Of 2876 procedures (mean age 63 years, 56% female), 120 (4.2%) developed PEP and 268 (9.3%) had prolonged/unplanned hospital admission. Univariate analysis showed patients with previous sphincterotomy 28/1054 (2.7%) had decreased risk of PEP compared with those without sphincterotomy 92/1822 (5.0%) (OR 0.52, p = .0021). This difference was not evident when multivariate analysis for age, sex and indication was undertaken due to a particularly low risk of PEP in stent change patients (1.4%), which were disproportionately represented in the previous sphincterotomy group. The rate of prolonged/unplanned hospital admission was recorded for a total of 2876 patients, occurring in 184/1802 (10.1%) in the native ampulla group, versus 84/1045 (8.0%) in the previous sphincterotomy group. CONCLUSIONS: The risk of PEP is halved by prior sphincterotomy. The presence of a biliary stent conferred an even lower risk of PEP (1.4%), but those without an in situ stent at the time of ERCP had a similar risk of PEP (4.6%) of prolonged/unplanned hospitalisation to those with a native ampulla.

Biliary Sphincterotomy Alone versus Biliary Stent with or without Biliary Sphincterotomy for the Management of Post-Cholecystectomy Bile Leak: A Systematic Review and Meta-Analysis.

BACKGROUND: Endoscopic therapy with endoscopic retrograde cholangiopancreatography is considered the first-line treatment in the management of post-cholecystectomy bile leak (PCBL). Currently, there is no consensus on the most effective endoscopic intervention for PCBL. Hence, we performed a systematic review and meta-analysis to compare the effectiveness and safety of the two interventional groups (biliary sphincterotomy [BS] alone vs. biliary stent ± BS) in management of PCBL. METHODS: We conducted a comprehensive search of multiple electronic databases and conference proceedings (from inception through January 2021). The primary outcome was to compare the pooled rate of clinical success between the 2 groups. The secondary outcome was to estimate the pooled rate of adverse events. RESULTS: The pooled rate of clinical success with BS alone (5 studies, 299 patients) was 88% (95% confidence interval (CI): 84-92%, I2: 0%) and for biliary stent ± BS (5 studies, 864 patients) was 97% (CI: 93-100%, I2: 79%). The rate of clinical success in biliary stent ± BS group was significantly higher than BS alone group (OR: 3.91 95% CI: 2.29-6.69, p < 0.001, I2: 13%). The rate of adverse events was numerically lower in biliary stent ± BS group compared to BS alone (3 studies; OR: 0.65 95% CI: 0.41-1.03, p = 0.07) without statistical significance. Low heterogeneity was noted in the analysis. CONCLUSIONS: Biliary stent ± BS is more effective in endoscopic management of PCBL compared to BS alone. This may be related to inter-endoscopist variation in completeness of sphincterotomy and post-sphincterotomy edema, which can influence the preferential trans-papillary flow of bile.

A systematic review and meta-analysis of the efficacy of topical sphincterotomy treatments for anal fissure.

BACKGROUND: Anal fissure is a common condition that can be treated medically or surgically. Chemical sphincterotomy is often used before surgical intervention. This study aims to evaluate the effectiveness of topical agents for chemical sphincterotomy on healing of anal fissures and side-effects. METHODS: A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) compliant systematic review was performed using MEDLINE, EMBASE, Scopus, and CENTRAL databases. Eligible studies included randomized controlled trials which compared topical sphincterotomy agents with topical placebo agents or each other. Studies that included surgical treatments were excluded. Overall evidence was synthesized according to the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. RESULTS: Thirty-seven studies met the study selection criteria. Seventeen studies show that glyceryl trinitrate (GTN) was significantly more likely to heal anal fissure than placebo (relative risk (RR) = 1.96, 95% confidence interval (95%CI) = 1.35-2.84, I2 = 80%). Eleven studies showed a marginally significant difference between healing rates for diltiazem vs GTN, RR = 1.16, (1.01-1.33) I2 = 48%. There was no significant difference in healing between diltiazem and placebo, RR = 1.65, (0.64-4.23), I2 = 92%. GTN significantly reduced pain on the visual analog scale compared to the placebo group, MD-0.97 (-1.64 to -0.29) I2 = 92%. There was high certainty of evidence that GTN was significantly more likely to cause headache than placebo (RR = 2.73 (1.82-4.10) I2 = 58%) and diltiazem RR = 6.88 (2.19-21.63) I2 = 17%. CONCLUSION: There is low certainty evidence topical nitrates are an effective treatment for anal fissure healing and pain reduction compared to placebo. Despite widespread use of topical diltiazem, more evidence is required to establish the effectiveness of calcium channel blockers compared to placebo.

[External sphincterotomy in neurological patients with detrusor sphincter dyssynergia: Short and mid-term results]. / Résultat à court et moyen terme du traitement de la dyssynergie vésico-sphinctérienne par sphinctérotomie endoscopique.

BACKGROUND: To evaluate in the short and mid-term the success of external sphincterotomy (ES) in neurological patients with detrusor sphincter dyssynergia (DSD). METHODS: Retrospective, monocentric study, conducted in 51 patients who had a first ES between January 2003 and June 2018, with at least two years of follow-up. The success of ES was defined by maintenance of reflex voiding mode at the end of follow-up. Secondary outcomes were early postoperative complications, rate of revision, functional impact, urodynamic follow-up and upper urinary tract impact. RESULTS: The median age was 50.6 years and the median follow-up was 4.6 years. The success rate was 80% (n=41). Ten patients had to change their voiding mode. For 5 patients, it was related to secondary detrusor low contractility. A second ES was required for 39% of patients. At the end of follow-up, there was a significant improvement in Autonomic Dysreflexia (AD) (26 vs 7 patients, P<0.001), urinary tract infections (UTI) (31 vs 15 patients, P<0.001) and a significant decrease in post-voiding residuals (200 vs 50mL, P<0.001). CONCLUSION: ES allowed to maintain reflex voiding in 80% of our patients. It significantly improves AD and UTI despite a high rate of re-operation (39%). A long-term follow-up is mandatory in order not to ignore a recurrence of bladder outlet obstruction and/or decrease in detrusor contractility, which may justify a re-operation or an alternative bladder management. LEVEL OF EVIDENCE: III.

Delorme surgery for colonic mucosal prolapse after intersphincteric resection.

PURPOSE: Mucosal prolapse at the site of anastomosis is a long-term complication unique to ISR. It reduces the QOL of patients due to a worsened anal function and local symptoms around the anus. We herein sought to assess the surgical outcomes after Delorme surgery for these patients. METHODS: ISR was performed in 720 patients with low rectal cancer between January 2001 and March 2019 at the National Cancer Center Hospital East. Among these patients, the 33 (4.5%) who underwent initial Delorme surgery for postoperative colonic mucosal prolapse were identified from the medical records and then were analyzed retrospectively. We estimated the anal function using Wexner's incontinence score and assessed whether local anal symptoms due to the prolapse improved postoperatively. RESULTS: Stoma closure was performed before Delorme surgery in 15 (45.5%) patients, and we compared the preoperative and postoperative anal function in these patients. The average Wexner's incontinence score changed from 15.1 before to 12.9 after Delorme surgery. Local symptoms around the anus improved in all 33 (100%) patients. Recurrence of colonic mucosal prolapse occurred in 5 patients (15%), and Delorme surgery was reperformed in these cases. CONCLUSION: Delorme surgery for colonic mucosal prolapse following ISR has clinical benefits for both improving anal local symptoms and slightly improving the anal function.

Magnetic sphincter augmentation: a viable rescue therapy for symptomatic reflux following bariatric surgery.

INTRODUCTION: Laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) are commonly performed bariatric procedures in obesity management. Gastroesophageal reflux disease (GERD) in this population has reported rates of 23-100%. GERD after LSG has been noted with recent studies demonstrating de novo reflux or symptom exacerbation despite weight loss. Fundoplication is not an option, and medically refractory GERD after LSG is usually treated with conversion to RYGB. GERD post-RYGB is a unique entity, and management poses a clinical and technical challenge. We evaluate safety and effectiveness of magnetic sphincter augmentation after bariatric surgery. MATERIALS AND METHODS: A retrospective review of a prospectively maintained database was performed identifying patients that underwent LINX placement for refractory GERD after LSG, LRYGB, or duodenal switch across three institutions. Outcomes included complications, length of stay, PPI use, GERD-HRQL scores, and patient overall satisfaction. RESULTS: From March 2014 through June 2018, 13 identified patients underwent LINX placement after bariatric surgery: 8 LSG, 4 LRYGB, and 1 duodenal switch. The patients were 77% female, with mean age 43 and average BMI 30.1. Average pre-operative DeMeester score was 24.8. Pre-operatively, 5 patients were on daily PPI, 6 on BID PPI, and 1 on PPI + H2 blocker. We noted decreased medication usage post-operatively, with 4 patients taking daily PPI, and 9 off medication completely. A GERD-HRQL score was obtained pre- and post-operatively in 6 patients with average reduction from 25 to 8.5 (p value 0.002). Two patients experienced complications requiring endoscopic dilation after LINX placement. 100% of patients reported overall satisfaction post procedure. CONCLUSION: LINX placement is a safe, effective treatment option for surgical management of refractory GERD after bariatric surgery. It can relieve symptoms and obviate the requirement of high-dose medical management. Magnetic lower esophageal sphincter augmentation should be another tool in the surgeon's toolbox for managing reflux after bariatric surgery in select patients.

Sphincterotomy for biliary sphincter of Oddi dysfunction.

The review is withdrawn as it has not been maintained since its first publication in 2001 (searches date back to the year 2000). Since then, new trials have been published that may or may not change the conclusions of the review. A new team of authors overtook the review on 26.10.2020, and the new review is expected to be published by the beginning of 2022. The review will be prepared based on most recent Cochrane methods. Readers may still find the outdated review on the CDSR (the Cochrane Library).

Comparative efficacy of medical treatment versus surgical sphincterotomy in the treatment of chronic anal fissure.

BACKGROUND: Anal fissure which is defined as a longitudinal tear in anoderm below the dentate line is one of the most common benign diseases of anorectal area. Severe pain during the defecation and emotional stress that it causes may reduce people's quality of life. AIMS: In this randomized clinical trial, we aimed to compare the efficiency of the topical ointment with medical treatment and surgical lateral internal sphincterotomy. METHOD: This is a randomized clinical trial of 550 patients who were treated for chronic anal fissure. Patients were randomly divided into 4 groups according to the treatment type they received. RESULTS: In a vast majority of the patients, the primary complaint was pain (92.3%) and bleeding during defecation (62%). Both pain relief and healing of the fissure, which are the components of response to treatment, had not been observed in 56 (37.3%) patients of topical nitroglycerin ointment group until the second month. Among the recalcitrant patients in both topical nitroglycerin (56) and topical diltiazem ointment (47) groups, 27 (48.2%), and 36 (76.5%) patients underwent surgery, respectively. The best response to treatment was also obtained in lateral internal sphincterotomy group. CONCLUSION: LIS is still the gold standard for the treatment of chronic anal fissure when the physicians would like to avoid recurrence and obtain the best pain relief.

Endoscopic management of postcholecystectomy biliary leak: When and how? A nationwide study.

BACKGROUND AND AIMS: ERCP is considered the first-line therapy for biliary duct leaks (BDLs). However, the optimal ERCP timing and endotherapy methods remain controversial. Our aim was to evaluate these factors as predictors of poor clinical outcomes after BDLs. METHODS: Adults who underwent ERCP for BDLs after cholecystectomy were identified from the Nationwide Inpatient Sample from 2000 to 2014. ERCP was classified as emergent, urgent, and expectant if it was done within 1 day, after 2 to 3 days, or >3 days after BDLs, respectively. Endotherapy was classified into sphincterotomy, stent, or combination. Post-ERCP adverse events (AEs) were defined as requiring pressor infusion, endotracheal intubation, invasive monitoring, or hemodialysis. Early endotherapy failure was defined as the need for salvage surgical or radiology-percutaneous biliary intervention after ERCP. RESULTS: A total of 1028 patients with a median age of 56 years were included. ERCP was done emergently (19%), urgently (30%), and expectantly (51%). Endotherapy procedures were sphincterotomy (24%), biliary stent (24%), and combination (52%). Post-ERCP AEs were 11%, 10%, and 9% for emergent, urgent, and expectant ERCP, respectively (P = .577). In-hospital mortality showed a U-shape trend of 5%, 0%, and 2% for emergent, urgent, and expectant ERCP, respectively (P < .001). Combination and stent monotherapy had lower failure rates of 3% and 4%, respectively as compared with sphincterotomy monotherapy with failure rate of 11% (P < .001). When multivariate analysis was used, both combination (odds ratio, .2; 95% confidence interval, .1-.5) and stent monotherapy (odds ratio, .4; 95% confidence interval, .2-.9) were less likely to fail as compared with sphincterotomy monotherapy. There were no statistically significant differences between combination therapy and stent monotherapy in the univariate and the multivariate analyses. CONCLUSIONS: Although limited by retrospective design and the possibility of selection bias, this analysis suggests that the timing of ERCP is not a significant predictor of post-ERCP AEs after BDLs. Furthermore, combination or stent monotherapy had lower failure rates as compared with sphincterotomy monotherapy.

Outcome of Modified Park's Technique for Treatment of Complex Anal Fistula.

BACKGROUND: Treatment of complex anal fistula (CAF) can be associated with high rates of recurrence and fecal incontinence (FI). Park suggested drainage of the affected intersphincteric anal gland for treatment of cryptoglandular anal fistula; however, recurrence after this technique was high. We modified the original Park's technique by extending the internal sphincterotomy to ensure adequate drainage of the intersphincteric space. The aim of this study was to evaluate the incidence of recurrence and FI after modified Park's technique in treatment of CAF. METHODS: Adult patients of both genders with CAF were evaluated before undergoing modified Park's technique with Wexner continence score, clinical examination, and endoanal ultrasonography or MRI. Postoperatively, patients were examined every 2 wk until complete wound healing. The continence state was evaluated with Wexner continence score, and quality of life was assessed before surgery and at 6 mo postoperatively by Short Form-36 questionnaire. RESULTS: Thirty-two patients (27 male) of a mean age of 38 y were included. Median follow-up was 12 mo. Two patients (6.25%) experienced recurrence and 5 (15.6%) developed complications. One patient (3.1%) developed new-onset FI postoperatively. Twenty-eight (87.5%) patients were completely satisfied with the procedure. Quality of life showed significant improvement at 6 mo postoperatively. CONCLUSIONS: The modified Park's technique is a promising procedure for the treatment of CAF with low recurrence and FI rates, and improved quality of life.

Peroral endoscopic myotomy versus pneumatic dilation - result from a retrospective study with 1-year follow-up.

BACKGROUND AND AIMS: On the basis of lesser rates of major adverse events and a short-term efficacy as Heller's myotomy, there is a growing enthusiasm in favor of peroral endoscopic myotomy (POEM), whereas study comparing POEM and pneumatic dilatation (PD) is quite rare. The aim of this study was to evaluate the efficacy of POEM and PD in Chinese achalasia patients in a retrospectively designed study. METHODS: Patients with achalasia, who underwent either PD (n = 26) or POEM (n = 40) were retrospectively recruited from September 2010 through March 2016 at a single tertiary center. During the 1-year follow-up, clinical outcome and functional data of lower esophageal sphincter (LES) were recruited. Clinical symptoms were assessed by use of the Eckardt score. The primary outcome was therapeutic success (Eckardt score ≤ 3). Functional data of LES (4-second integrated relaxation pressure [4s-IRP], LES relax rate, and LESP) at baseline and 1 month after treatment were also evaluated. Data was analyzed by SPSS 13.0 version using a significance level of p < 0.05. RESULTS: The success rates were 24/26 (92.31 %), 25/26 (96.15 %), and 24/26 (92.31 %), respectively, with POEM, as compared with 35/40 (87.50 %), 29/40 (72.50 %), and 23/40 (57.50 %), respectively, with PD, 1 month, 3 months, and 1 year after treatment. Statistically significant difference was observed between the 2 therapies (at 3 months, Fisher's exact test, p = 0.01; at 1 year, Fisher's exact test, p < 0.0001). Compared with PD, the Eckardt score was lower with POEM 1 month, 3 months, and 1 year after treatment. More patients in POEM group reported gastroesophageal reflux symptoms (after 3 months 7/26 (26.92 %) vs. 2/40 (5.00 %), Fisher's exact test, p = 0.01; after 1 year 6/26 (19.23 %) vs. 1/35 (2.86 %), Fisher's exact test, p = 0.02). The postoperative 4s-IRP and LESP were both lower with POEM than with PD, respectively. Type I achalasia had a better response with POEM than with PD. CONCLUSION: In this retrospective analysis with 1-year follow-up, POEM presents with a higher success rate and more reflux symptoms compared with PD. Change on LES function after treatment may explain the outcome in part. Type I achalasia may respond better to therapies compared with type II.

Effect of Peroral Endoscopic Myotomy vs Pneumatic Dilation on Symptom Severity and Treatment Outcomes Among Treatment-Naive Patients With Achalasia: A Randomized Clinical Trial.

Importance: Case series suggest favorable results of peroral endoscopic myotomy (POEM) for treatment of patients with achalasia. Data comparing POEM with pneumatic dilation, the standard treatment for patients with achalasia, are lacking. Objective: To compare the effects of POEM vs pneumatic dilation as initial treatment of treatment-naive patients with achalasia. Design, Setting, and Participants: This randomized multicenter clinical trial was conducted at 6 hospitals in the Netherlands, Germany, Italy, Hong Kong, and the United States. Adult patients with newly diagnosed achalasia and an Eckardt score greater than 3 who had not undergone previous treatment were included. The study was conducted between September 2012 and July 2015, the duration of follow-up was 2 years after the initial treatment, and the final date of follow-up was November 22, 2017. Interventions: Randomization to receive POEM (n = 67) or pneumatic dilation with a 30-mm and a 35-mm balloon (n = 66), with stratification according to hospital. Main Outcomes and Measures: The primary outcome was treatment success (defined as an Eckardt score ≤3 and the absence of severe complications or re-treatment) at the 2-year follow-up. A total of 14 secondary end points were examined among patients without treatment failure, including integrated relaxation pressure of the lower esophageal sphincter via high-resolution manometry, barium column height on timed barium esophagogram, and presence of reflux esophagitis. Results: Of the 133 randomized patients, 130 (mean age, 48.6 years; 73 [56%] men) underwent treatment (64 in the POEM group and 66 in the pneumatic dilation group) and 126 (95%) completed the study. The primary outcome of treatment success occurred in 58 of 63 patients (92%) in the POEM group vs 34 of 63 (54%) in the pneumatic dilation group, a difference of 38% ([95% CI, 22%-52%]; P < .001). Of the 14 prespecified secondary end points, no significant difference between groups was demonstrated in 10 end points. There was no significant between-group difference in median integrated relaxation pressure (9.9 mm Hg in the POEM group vs 12.6 mm Hg in the pneumatic dilation group; difference, 2.7 mm Hg [95% CI, -2.1 to 7.5]; P = .07) or median barium column height (2.3 cm in the POEM group vs 0 cm in the pneumatic dilation group; difference, 2.3 cm [95% CI, 1.0-3.6]; P = .05). Reflux esophagitis occurred more often in the POEM group than in the pneumatic dilation group (22 of 54 [41%] vs 2 of 29 [7%]; difference, 34% [95% CI, 12%-49%]; P = .002). Two serious adverse events, including 1 perforation, occurred after pneumatic dilation, while no serious adverse events occurred after POEM. Conclusions and Relevance: Among treatment-naive patients with achalasia, treatment with POEM compared with pneumatic dilation resulted in a significantly higher treatment success rate at 2 years. These findings support consideration of POEM as an initial treatment option for patients with achalasia. Trial Registration: Netherlands Trial Register number: NTR3593.