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INTRODUCTION:Peroral endoscopic myotomy (POEM) may result in a distended distal esophagus, referred to as a blown-out myotomy (BOM), the relevance of which is uncertain. The aim of this study was to investigate the prevalence, risk factors, and associated symptoms of BOM after achalasia treatment.METHODS:A data set of the locally treated patients in a randomized controlled trial comparing POEM with pneumatic dilation (PD) was analyzed. A BOM is defined as a >50% increase in esophageal diameter at its widest point in the distal esophagus between the lower esophageal sphincter and 5 cm above.RESULTS:Seventy-four patients were treated in our center, and 5-year follow-up data were available in 55 patients (32 patients [58%] randomized to POEM, 23 [42%] PD). In the group initially treated with POEM, the incidence of BOM increased from 11.5% (4/38) at 3 months, to 21.1% (8/38) at 1 year, 27.8% (10/36) at 2 years, and 31.3% (10/32) at 5 years. None of the patients treated with PD alone developed a BOM. Patients who developed a BOM had a higher total Eckardt score and Eckardt regurgitation component compared with patients who underwent POEM without BOM development (3 [2.75-3.25] vs 2 [1.75-3], P = 0.032, and 1 [0.75-1] vs 0 [0-1], P = 0.041). POEM patients with a BOM more often report reflux symptoms (85% [11/13] vs 46% [2/16], P = 0.023) and had a higher acid exposure time (24.5% [8-47] vs 6% [1.2-18.7], P = 0.027).DISCUSSION:Thirty percent of the patients treated with POEM develop a BOM, which is associated with a higher acid exposure, more reflux symptoms, and symptoms of regurgitation.

To compare the utility of the distensibility index (DI) on functional lumen imaging probe (FLIP) topography to other esophagogastric junction (EGJ) metrics in assessing treatment response in achalasia in the context of esophageal anatomy. We prospectively evaluated 79 patients (at ages 17-81 years; 47% female patients) with achalasia during follow-up after pneumatic dilation, Heller myotomy, or per-oral endoscopic myotomy with timed barium esophagram, high-resolution impedance manometry, and FLIP. Anatomic deformities were identified based on consensus expert opinion. Patients were classified based on anatomy and EGJ opening to determine the association with radiographic outcome and Eckardt score (ES). Twenty-seven patients (34.1%) had an anatomic deformity-10 pseudodiverticula at myotomy, 7 epiphrenic diverticula, 5 sigmoid, and 5 sinktrap. A 5-minute column area of >5 cm was best associated with an ES of >3, with a sensitivity of 84% (P = 0.0013). Area under the curve for EGJ metrics in association with retention was as follows: DI, 0.90; maximal EGJ diameter, 0.76; integrated relaxation pressure, 0.64; and basal esophagogastric junction pressure, 0.53. Only FLIP metrics were associated with retention given normal anatomy (DI 2.4 vs 5.2 mm/mm Hg and maximal EGJ diameter 13.1 vs 16.6 mm in patients with and without retention, respectively; P values < 0.0001 and 0.002). Using a DI cutoff of <2.8 as abnormal, 40 of 45 patients with retention (P = 0.0001) and 23 of 25 patients with an ES of >3 (P = 0.02) had a low DI and/or anatomic deformity. With normal anatomy, 21 of 22 patients with retention had a low or borderline low DI. The FLIP DI is most useful metric for assessing the effect of achalasia treatment on EGJ opening. However, abnormal anatomy is an important mediator of outcome and treatment success will be modulated by anatomic defects that impede bolus emptying.

Introduction and Hypothesis The objective was to evaluate the safety and effectiveness of an intrapartum electromechanical pelvic floor dilator designed to reduce the risk of levator ani muscle (LAM) avulsion during vaginal delivery. Methods A multicenter, randomized controlled trial enrolled nulliparous participants planning vaginal delivery. During the first stage of labor, participants were randomized to receive the intravaginal device or standard-of-care labor management. The primary effectiveness endpoint was the presence of full LAM avulsion on transperineal pelvic-floor ultrasound at 3 months. Three urogynecologists performed blinded interpretation of ultrasound images. The primary safety endpoint was adverse events (AEs) through 3 months. Results A total of 214 women were randomized to Device ( n  = 113) or Control ( n  = 101) arms. Of 113 Device assignees, 82 had a device placed, of whom 68 delivered vaginally. Of 101 Control participants, 85 delivered vaginally. At 3 months, 110 participants, 46 Device subjects who received full device treatment, and 64 Controls underwent ultrasound for the per-protocol analysis. No full LAM avulsions (0.0%) occurred in the Device group versus 7 out of 64 (10.9%) in the Control group ( p  = 0.040; two-tailed Fisher’s test). A single maternal serious AE (laceration) was device related; no neonate serious AEs were device related. Conclusions The pelvic floor dilator device significantly reduced the incidence of complete LAM avulsion in nulliparous individuals undergoing first vaginal childbirth. The dilator demonstrated an acceptable safety profile and was well received by recipients. Use of the intrapartum electromechanical pelvic floor dilator in laboring nulliparous individuals may reduce the rate of LAM avulsion, an injury associated with serious sequelae including pelvic organ prolapse.

Background This study compares the long-term results of pneumatic dilatations versus laparoscopic myotomy using treatment failure as the primary outcome. The frequency and degree of dysphagia, the effects on quality of life (QoL), and health economy were also examined. Methods Fifty-three patients with achalasia were randomized to laparoscopic myotomy with a posterior partial fundoplication [laparoscopic myotomy (LM) n  = 25] or repetitive pneumatic dilatation [pneumatic dilatation (PD) n  = 28]. The median observation period was 81.5 months (range 12–131). Results At the minimal follow-up of 5 years, ten patients (36 %) in the dilatation group and two patients (8 %) in the myotomy group, including two patients lost to follow-up (one in each arm), were classified as failures ( p  = 0.016). The cumulative incidence of treatment failures was analyzed by survival statistics. Taking the entire follow-up period into account, a significant difference was observed in favor of the LM strategy ( p  = 0.02). Although both treatments resulted in significant improvements in dysphagia scores, LM was significantly favored over PD after 1 and 3 years, but not after 5 years. Health-related QoL assessed by the personal general well being score was higher in the LM group after 3 years, but the difference was not fully statistically significant at 5 years. Direct medical costs during the entire follow-up period were in median $13,421 for LM as compared to $5,558 for PD ( p  = 0.001). Conclusions This long-term follow-up of a randomized clinical study shows that LM is superior to repetitive PD treatment of newly diagnosed achalasia, albeit that this surgical strategy is burdened by high initial direct medical costs. www.ClinicalTrials.gov NCT 02086669

This study was designed to evaluate the non-inferiority of ultrasound puncture followed by endoscopically guided tract dilatation compared to the standard fluoroscopy-guided PCNL. Forty patients with non-opaque kidney stones eligible for PCNL were randomly divided into two groups. The standard fluoroscopy-guided PCNL using the Amplatz dilator was performed in the XRAY group. In the SONO group, the Kidney was punctured under an ultrasound guide followed by tract dilatation using a combination of the Amplatz dilator based on the tract length and an endoscopically guided tract dilatation using a bi-prong forceps in cases of short-advancement. The primary outcome was successful access. In 90% of cases in the XRAY and 95% in the SONO group access dilatation process was performed uneventfully at the first attempt (p = 0.5). In 45% of cases in the SONO group, bi-prong forceps were used as salvage for short-advancement. In one case in the X-ray group over-advancement occurred. One month after surgery, the stone-free rate on the CT-scan was 75% for the X-ray group and 85% for the SONO group (p = 0.4). There were no significant differences in operation time, hospitalization duration, transfusion, or complication rates between the two groups. We conclude that ultrasound-guided renal puncture, followed by endoscopically guided tract dilatation can achieve a high success rate similar to X-ray-guided PCNL while avoiding the harmful effects of radiation exposure and the risk of over-advancement.

BackgroundPatients with benign esophageal strictures may not maintain a response to endoscopic dilation, stenting, incisional or injectional therapies. For patients with these refractory esophageal strictures, esophageal self-dilation therapy (ESDT), performed to maintain luminal patency, may provide persistent symptomatic benefit while reducing patients’ reliance on healthcare services and the risk associated with repeated endoscopic procedures.AimsThe aim of this study was to evaluate the efficacy and safety of EDST in a randomized controlled trial and prospective observational study.MethodsTwenty-five patients with refractory benign esophageal strictures were recruited at two esophageal clinics between November 2018 and June 2021. Twelve patients participated in the randomized trial and 13 in the prospective observational study. The number of endoscopic dilations, impact of therapy on dysphagia, adverse events, and complications were recorded.ResultsIn the randomized study, 50% of patients performing ESDT and 100% of controls required endoscopic dilation during follow-up (P = 0.02). In the observational study, the median (IQR) number of endoscopic dilations fell from 7 [7–10] in the 6 months prior to commencing ESDT to 1 [0–2] in the 6 months after (P < 0.0001). Most patients (22/25) were able to learn self-dilation. Few serious adverse events were noted. Dysphagia severity remained unchanged or improved.ConclusionsESDT appears to be a safe effective therapy for benign esophageal strictures refractory to endoscopic treatment.Clinical Trial NumberNCT03738566.

Objectives A novel partially self‐expandable metal stent (PCSEMS) with an anti‐migration system has recently become available during Endoscopic ultrasound‐guided hepaticogastrostomy (EUS‐HGS) but requires tract dilation. No previous study has compared the performance of dilation devices during EUS‐HGS. The aim of this randomized controlled trial was to evaluate the technical success rate of tract dilation between a balloon catheter and drill dilator technique during EUS‐HGS prior to insertion of SEMS with an anti‐migration system. Methods A single‐center, randomized controlled trial comparing the balloon dilation and drill dilator techniques for first‐line tract dilation during EUS‐HGS. The primary outcome was the initial technical success rate of tract dilation for each technique during EUS‐HGS. The secondary outcome was adverse events associated with the procedures. Results Of 54 randomized patients who underwent EUS‐HGS at our center, there were 27 in the balloon dilation group and 27 in the drill dilation group. The initial technical success rate was 92.6% (25/27) in the balloon dilation group and 100% (27/27) in the drill dilation group (p = 0.1495). The technical success rate of stent delivery system insertion was significantly higher in the balloon dilation group (88%, 22/25) than in the drill dilation group (45%, 13/27; p = 0.0013). Procedure time was significantly shorter in the balloon dilation group (mean, 9.7 min) than in the drill dilation group (mean, 14.0 min; p = 0.047). Adverse events were more frequent in the drill dilation group (7.4% vs. 29.6%, p = 0.038). Conclusions Balloon dilation appears more suitable than drill dilation for PCSEMS with 8.5 Fr stent delivery system deployment. Clinical trial registration number University Hospital Medical Information Network 000049550.

Up to 60% of patients with common bile duct stone (CBDS) recurrence suffer from further recurrence after endoscopic retrograde cholangiopancreatography (ERCP). There are no effective methods to prevent recurrence in most patients. In this study, we aimed to assess the short-term and long-term efficacies of endoscopic papillary large balloon dilation (EPLBD) for the management of recurrent CBDS in a randomized controlled trial. Consecutive patients with recurrent CBDS were eligible and randomly assigned in a 1:1 ratio to the EPLBD group or the control group. The primary outcome was the CBDS recurrence rate within 2 years after ERCP. The analysis followed the intention-to-treat principle. From 2014 to 2021, 180 patients with recurrent CBDS were included, with 90 in each group. All patients underwent complete CBDS clearance by 1 or several sessions of ERCP. The rate of complete clearance in 1 session was significantly higher with EPLBD treatment (95.6% vs 85.6%, P = 0.017). During the follow-up, the CBDS recurrence rate within 2 years was significantly lower in the EPLBD group than in the control group (21.1% [19/90] vs 36.7% [33/90], relative risk 0.58, 95% confidence interval 0.36-0.93, P = 0.021). At a median follow-up of approximately 56 months, CBDS recurrence was found in 34.4% of the patients (31/90) in the EPLBD group and 51.1% (46/90) in the control group (hazard ratio 0.57, 95% confidence interval 0.36-0.89, P = 0.012). Multiple recurrences (≥2) were also decreased in the EPLBD group (4.4% vs 18.9%, P = 0.020). During the long-term follow-up, nearly half of the patients with recurrent CBDS experienced stone recurrence after traditional ERCP. Our study was the first to show that EPLBD effectively reduced the recurrence of CBDS.

Background The double-stapling technique (DST) for esophagojejunostomy using the transorally inserted anvil (OrVil; Covidien Japan, Tokyo, Japan) is one of the reconstruction methods used after laparoscopy-assisted total gastrectomy (LATG). This technique has potential advantages in terms of less invasive surgery without the need to create a complicated intraabdominal anastomosis. Methods From 2008 to 2011, 262 patients with gastric cancer underwent total gastrectomy and reconstruction with a Roux-en-Y anastomosis, and 52 patients underwent LATG with DST. A retrospective analysis then was performed comparing the patients who experienced postoperative stenosis after LATG-DST (positive group) and the patients who did not (negative group). A comparative analysis was performed among patients comparing conventional open total gastrectomy and LATG, and multivariate analysis was performed to evaluate risk factors for the development of anastomotic stenosis. Results A minor leak was found in 1 patient (1.9 %), and 11 patients experienced anastomotic stenosis (21 %) after LATG with DST. Among the patients with anastomotic stenosis, three (3/4, 75 %) anastomoses were performed with the 21-mm end-to-end anastomosis (EEA) stapler, and eight anastomoses were performed (8/47, 17 %) with the 25-mm EEA stapler. The median interval to the diagnosis of anastomotic stenosis was 43 days after surgery. The patients with stenosis needed endoscopic balloon dilation an average of four times, and the rate of perforation after dilation was 13 %. The clinical and operative characteristics did not differ between the two groups. Anastomotic stenosis after open total gastrectomy occurred in two cases (0.98 %). Multivariate analysis showed that the size of the EEA stapler and the use of DST were risk factors for anastomotic stenosis. Conclusion Esophagojejunostomy using DST with OrVil is useful in performing a minimally invasive procedure but carries a high risk of anastomotic stenosis.

Periampullary diverticulum (PAD) often increases the difficulty of ERCP operation, and there is no standardized treatment strategy. This study compared the efficacy of “small incision + large balloon dilation (EST + EPBD)” with traditional ERCP. 111 patients with PAD complicated with choledocholithiasis were randomly divided into experimental group ( n  = 55, EST < 5 mm + EPBD) and control group ( n  = 56, conventional EST/EPBD). The primary endpoints were one-time stone clearance and adverse event rate, while secondary endpoints included operative time and common bile duct pressure. One-time stone clearance rate: test group 98.1% vs. control group 87.5% ( P  = 0.029) • Mean operation time: 24 ± 9 min vs. 31 ± 11 min ( P  < 0.001) • CBD pressure 6 days after surgery: 11.5 ± 2.3 vs. 8.5 ± 1.6 cm H₂O ( P  < 0.001) • Incidence of postoperative pancreatitis: 3.6% vs. 10.7% ( P  = 0.206). EST + EPBD can significantly improve stone removal efficiency, shorten operation time, and may improve long-term prognosis by preserving Oddi sphincter function.