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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.

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.

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

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.

Introduction and Hypothesis Vaginismus is characterized by the involuntary spasm of the pelvic floor muscles (PFMs) around the outer third of the vagina, leading to difficulties in vaginal penetration. Physical therapists often use biofeedback to help individuals to gain better control over their muscles. This study was aimed at assessing the impact of biofeedback with dilator therapy on sexual function in women with primary vaginismus. Methods In this randomized controlled trial study, 32 women with primary vaginismus, aged 18 to 45, were randomly assigned to either the experimental group ( n  = 16) or the control group ( n  = 16). The experimental group received both dilator therapy and biofeedback training, whereas the control group only received dilator therapy. Both groups followed a 6-week, twice-a-week session program. The Female Sexual Function Index (FSFI) questionnaire, which includes six dimensions (desire, arousal, lubrication, orgasm, satisfaction, and pain), was administered before and after the 6-week treatment, as well as 1 month after completion. Results The analysis of variance test showed that the interaction effect of the group and time on the overall score of sexual function ( p  < 0.001) and the aspects of desire ( p  < 0.001), arousal ( p  < 0.001), orgasm ( p  = 0.028), satisfaction ( p  < 0.001), and pain ( p  = 0.003) were significant; however, the interaction between group and time ( p  = 0.182) was not observed for lubrication. Conclusion Biofeedback therapy combined with dilator therapy and dilator therapy alone are both effective in improving sexual function in women with primary vaginismus. However, women undergoing biofeedback combined with dilator therapy seem to benefit more than those receiving dilators alone.

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.

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.

Background The first-line treatment for common bile duct stones (CBDS) is endoscopic transpapillary stone removal, typically performed using either endoscopic sphincterotomy (EST) or endoscopic papillary balloon dilation (EPBD). However, EST is associated with risks of bleeding and perforation, while EPBD carries a significant risk of post-procedural pancreatitis. Recently, a combined approach involving minimal EST followed by EPBD (ESBD) has been reported to mitigate these drawbacks, offering potentially safer and more effective outcomes. Nevertheless, no prospective study has adequately evaluated the utility of ESBD, as prior studies were mainly observational or limited by small sample sizes. Therefore, we designed a randomized controlled trial to investigate whether ESBD is superior to EST for the treatment of small CBDS. Methods This study is a multicenter, randomized, open-label, parallel-group trial; outcome assessors will not be blinded, but objective predefined criteria will be used to minimize bias. Eligible participants will include patients aged 18 years or older diagnosed with CBDS who require endoscopic stone removal, with eligibility confirmed via imaging modalities. After confirming eligibility, patients will be randomly assigned in a 1:1 ratio to either the ESBD group or the EST group. In the ESBD group, a minimal sphincterotomy will first be performed, followed by balloon dilation for stone extraction. In the EST group, a medium incision extending beyond the hooding fold will be performed prior to stone extraction. The primary endpoint is the incidence of procedure-related adverse events, including pancreatitis, bleeding, and perforation. Secondary endpoints include technical success rate, clinical success rate, procedure time, need for lithotripsy, and stone recurrence rate. Discussion This study is the first multicenter, randomized controlled trial to prospectively evaluate the efficacy and safety of ESBD for the treatment of small CBDS. The findings are expected to determine whether ESBD can serve as a new standard therapeutic option compared with conventional EST. Trial registration Japan Registry of Clinical Trials: jRCT1040250008. Registered on 21 April 2025. ( https://jrct.mhlw.go.jp/en-latest-detail/jRCT1040250008 ).

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.