Clinical outcomes of drug-coated balloons dilatation for benign esophageal stricture.

BACKGROUND: Drug-coated balloons (DCBs) angioplasty is safe and effective for coronary artery disease. However, DCBs dilatation for the treatment of benign esophageal strictures is rarely reported. PURPOSE: We aimed to report the clinical outcomes of DCBs dilatation for patients with benign esophageal strictures. METHODS: From May 2020 to August 2023, 18 patients underwent DCBs dilatation for benign esophageal strictures. Baseline demographics were recorded and evaluated, including gender, age, comorbidities, stricture diameter and length, dilatation session, complications. RESULTS: A total of 24 dilatation sessions of DCBs were performed, with a mean of 1.3 ± 0.6 sessions per patients (range 1.0-5.0). Dysphagia score decreased significantly after DCBs dilatation (2.6 ± 1.1 vs. 0.9 ± 1.3, p = 0.0002). Both stricture diameter and stricture index decreased significantly after DCBs dilatation (p < 0.0001). No procedure-related death, massive bleeding or esophageal perforation was observed during or after DCBs dilatation. Minor complications were found in only 3 patients (16.7%). All 18 patients were successfully followed up for a median period of 12.0 months. By the end of follow up, 10 patients showed no dysphagia, 6 patients showed mild dysphagia and 2 patients showed no improvement in dysphagia. The clinical success rate of DCBs dilatation is 88.9%. CONCLUSION: DCBs dilatation may be a safe, effective and feasible treatment for benign esophageal strictures, and can be utilized as an alternative option after standard dilatation has failed. Prospective studies with large samples are needed to further validate its clinical efficacy.

Comparing Simulation Training of Bronchoscopy-Guided Percutaneous Dilatational Tracheostomy Using Conventional Versus 3D Printed Simulators (TRAC-Sim Study).

Background: Individual implementation rate of bronchoscopy-guided percutaneous dilatational tracheostomy (PDT) varies among intensivists. Simulation training (ST) can increase the safety of medical procedures by reducing stress levels of the performing team. The aim of this study was to evaluate the benefit of ST in PDT regarding procedural time, quality of performance, and percepted feelings of safety of the proceduralist and to compare conventional simulators (CSIM) with simulators generated from 3D printers (3DSIM). Methods: We conducted a prospective, single-center, randomized, blinded cross-over study comparing the benefit of CSIM versus 3DSIM for ST of PDT. Participants underwent a standardized theoretical training and were randomized to ST with CSIM (group A) or 3DSIM (group B). After ST, participants' performance was assessed by two blinded examiners on a porcine trachea regarding time required for successful completion of PDT and correct performance (assessed by a performance score). Percepted feelings of safety were assessed before and after ST. This was followed by a second training and second assessment of the same aspects with crossed groups. Results: 44 participants were included: 24 initially trained with CSIM (group A) and 20 with 3DSIM (group B). Correctness of the PDT performance increased significantly in group B (p < .01) and not significantly in group A (p = .14). Mean procedural time required for performing a PDT after their second ST compared to the first assessment (p < .01) was lower with no difference between group A and group B and irrespective of the participants' previous experience regarding PDT, age, and sex. Moreover, percepted feelings of safety increased after the first ST in both groups (p < .001). Conclusions: ST can improve procedural skills, procedural time, and percepted feelings of safety of the proceduralist in simulated PDT.

Safety and Efficacy of Covered Self-Expandable Metallic Stent for Choledochojejunal Anastomotic Stricture: A Multi-Center Retrospective Cohort Study.

BACKGROUND: Benign choledochojejunal anastomotic stricture (CJS) is a complication of pancreaticoduodenectomy and choledochojejunostomy. Typically managed with endoscopic balloon dilatation, CJS has a high recurrence rate. Covered metallic stent (CMS) placement is a potential alternative; however, a comprehensive evaluation is lacking. OBJECTIVES: The aim of this study was to evaluate the treatment outcomes of CMS placement in patients with CJS. METHODS: We retrospectively analyzed patients who underwent balloon dilation via endoscopic retrograde cholangiopancreatography using a double-balloon endoscope for CJS between October 2010 and October 2023. The study outcomes included technical and clinical success rates, adverse event rates, choledochojejunal anastomotic stricture recurrence rates, and time to recurrence for balloon dilation and CMS treatment for CJS. RESULTS: There were 43 patients, 55 procedures (40 balloon dilation and 15 CMS placement). The technical and clinical success rates were 100% for both treatments. Recurrence of CJS was observed in 35% (14/40) of the patients in the balloon dilation group. The recurrence rate was significantly higher in the balloon dilation group than in the CMS group (35% vs. 0%, p = 0.006). The time to CJS recurrence was significantly shorter in the balloon dilation group than in the covered metallic stent group (NR vs. NR, p = 0.03). CONCLUSION: Placement of CMS for treating patients with CJS was demonstrated to be an effective and safe method with a lower recurrence rate than balloon dilation.

Clinical outcomes of serial endoscopic balloon dilation for duodenal Crohn's disease-associated strictures.

BACKGROUND: Endoscopic balloon dilation (EBD) is a safe and effective treatment for Crohn's disease (CD)-associated strictures. However, serial EBDs have rarely been reported. This study aimed to evaluate the efficacy and safety of serial EBDs for treating CD-associated duodenal strictures compared with intermittent EBDs. METHODS: Patients with CD-associated duodenal strictures who underwent EBD were recruited. The clinical data, stricture characteristics, number of EBDs, dilation diameter, complications, surgical interventions, and follow-up periods were recorded. Patients were divided into a serial dilation group and an intermittent dilation group to analyze the differences in safety and efficacy. RESULTS: Forty-five patients with duodenal CD-associated strictures underwent a total of 139 dilations. A total of 23 patients in the serial dilation group underwent 72 dilations, for a median of 3 (range 3 ~ 4) dilations per patient, and 22 patients in the intermittent dilation group underwent 67 dilations, for a median of 3 (range 1 ~ 6) dilations per patient. Technical success was achieved in 97.84% (136/139) of the patients. During the follow-up period, three patients in the intermittent dilation group underwent surgery, and the total clinical efficacy was 93.33% (42/45). No difference in safety or short-term efficacy was noted between the two groups, but serial EBDs exhibited significantly greater clinical efficacy between 6 months and 2 years. No significant difference in recurrence-free survival was observed, but the median longest recurrence-free survival and recurrence-free survival after the last EBD in the serial dilation group were 693 days (range 298 ~ 1381) and 815 days (range 502 ~ 1235), respectively, which were significantly longer than the 415 days (range 35 ~ 1493) and 291 days (range 34 ~ 1493) in the intermittent dilation group (p = 0.013 and p = 0.000, respectively). At the last follow-up, the mean diameter of the duodenal lumen was 1.17 ± 0.07 cm in the serial dilation group, which was greater than the 1.11 ± 0.10 cm in the intermittent dilation group (p = 0.018). We also found that the Simple Endoscopic Score for Crohn's Disease was associated with an increased risk of surgical intervention (HR 2.377, 95% CI 1.125-5.020; p = 0.023) and recurrence at 6 months after the last EBD (HR 0.698, 95% CI 0.511-0.953; p = 0.024), as assessed by univariate analysis. CONCLUSIONS: Compared to the intermittent EBDs, serial EBDs for duodenal CD-associated strictures exhibit greater clinical efficacy within two years and could delay stricture recurrence. We suggest that serial EBDs can be a novel option for endoscopic treatment of duodenal CD-associated strictures.

Effect of an Intrapartum Pelvic Dilator Device on Levator Ani Muscle Avulsion During Primiparous Vaginal Delivery: A Pilot Randomized Controlled Trial.

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.

Safety and efficacy of EsoFLIP dilation in patients with esophageal dysmotility: a systematic review.

Esophageal manometry is utilized for the evaluation and classification of esophageal motility disorders. EndoFlip has been introduced as an adjunctive test to evaluate esophagogastric junction (EGJ) distensibility. Treatment options for achalasia and EGJ outflow obstruction (EGJOO) include pneumatic dilation, myotomy, and botulinum toxin. Recently, a therapeutic 30 mm hydrostatic balloon dilator (EsoFLIP, Medtronic, Minneapolis, MN, USA) has been introduced, which uses impedance planimetry technology like EndoFlip. We performed a systematic review to evaluate the safety and efficacy of EsoFLIP in the management of esophageal motility disorders. A systematic literature search was performed with Medline, Embase, Web of science, and Cochrane library databases from inception to November 2022 to identify studies utilizing EsoFLIP for management of esophageal motility disorders. Our primary outcome was clinical success, and secondary outcomes were adverse events. Eight observational studies including 222 patients met inclusion criteria. Diagnoses included achalasia (158), EGJOO (48), post-reflux surgery dysphagia (8), and achalasia-like disorder (8). All studies used 30 mm maximum balloon dilation except one which used 25 mm. The clinical success rate was 68.7%. Follow-up duration ranged from 1 week to a mean of 5.7 months. Perforation or tear occurred in four patients. EsoFLIP is a new therapeutic option for the management of achalasia and EGJOO and appears to be effective and safe. Future comparative studies with other therapeutic modalities are needed to understand its role in the management of esophageal motility disorders.

Long-term efficacy of balloon dilation of the pediatric Eustachian tube: A six-year matched cohort study.

PURPOSE: Balloon dilation of the Eustachian tube (BDET) has not been evaluated extensively in children outside of retrospective case series. The purpose of this study is to report the long-term safety and efficacy of this procedure in children with matched controls. MATERIALS AND METHODS: This is a two-center retrospective matched cohort study. Children having undergone tympanostomy tube (TT) placement and adenoidectomy with recurrence of symptoms underwent BDET at an academic affiliated multi-specialty practice. Comparison was made with children receiving TT at a tertiary medical center, matching for number of prior TT, prior adenoidectomy, age, and sex. Outcome measures were risk of failure and the need for additional surgery. Kaplan-Meier survival plots were used to compare risk of failure. RESULTS: Thirty-three Eustachian tubes were dilated in 20 patients, aged 14 months-14 years. All patients had previously undergone TT insertion and adenoidectomy. Patients undergoing BDET had normal post-operative tympanograms in 80 % of cases. Mean follow up was 6.7 years with 2 patients failing in the BDET group and 8 in the TT insertion group. Dilated patients had a significantly lower risk of failure than those who underwent TT insertion (adjusted HR: 0.18; 95 % CI: 0.04, 0.81; p = 0.03). The probability of being failure free at six years was 88 % (95 % CI: 71, 95 %) in the BDET cohort and 53 % (95 % CI: 33, 70 %) in the TT insertion cohort. There were no complications. CONCLUSIONS: BDET appears to be safe and possibly superior to TT placement in children with refractory Eustachian tube dysfunction. LEVEL OF EVIDENCE: 2b.

Endoscopic balloon dilatation for pediatric subglottic stenosis: a meta-analysis of successful outcomes.

OBJECTIVES: The primary goal of this study was to systematically identify all relevant published articles on the use of primary endoscopic balloon dilation for the management of pediatric patients with subglottic stenosis, critically assess the technique's success, and determine which patients are the best candidates for the procedure. METHODOLOGY: This was a systematic review and meta-analysis that aimed to investigate the use and success rate of EBD for treating pediatric SGS. An electronic systematic literature search of three major databases, PubMed, EBSCO, and Web of Science&MEDLINE through Clarivate, was conducted to include the eligible articles. RESULTS: A total of 14 unique studies were included in the final analysis, with 473 cases of pediatric SGS. The pooled success rate of EBD in treatment of pediatric SGS was 76% (k = 14 studies, 95% confidence interval [CI] = 0.65-0.86, P < 0.001, Q test for heterogeneity = 0.03, P < .001, I2 = 91%). CONCLUSIONS: We reported a high success rate of EBD in treating pediatric SGS. The reported complications were uncommon, although they can be serious and life threatening. The intensity of SGS may be related to the likelihood of therapy failure.

Comparative Analysis of Silicone Tube Intubation Versus Probing and Balloon Dilation for Congenital Nasolacrimal Duct Obstruction: A Systematic Review and Meta-Analysis.

OBJECTIVE: Congenital nasolacrimal duct obstruction (CNLDO) is a pediatric disorder with a wide range of pathology. If untreated, the condition may end up with serious complications. Multiple treatment options for CNLDO exist throughout the literature, and there is an ongoing debate on the best intervention for each disease subgroup and the best timing of such interventions. This study compares the success and failure rates of silicone tube intubation (STI) against probing and balloon dilation (BD). METHODS: The authors searched the literature for relevant articles using PubMed, Scopus, web of Science, and Cochrane Library until January 2024. Using RevMan 5.4, the authors compared STI's success and failure rates to probing and BD using risk ratios (RRs) and a random-effect model. In addition, the complication rate of monocanalicular intubation (MCI) versus bicanalicular intubation (BCI) was investigated. The authors used the leave-one-out method to check for influential studies and to resolve heterogeneity. RESULTS: The screening process resulted in 23 eligible articles for inclusion in the authors' review. Silicone tube intubation had a higher chance of resolving the symptoms of CNLDO than probing (RR = 1.11; 95% CI: 1.04, 1.20; P = 0.004) while having less risk of surgical failure (RR = 0.48; 95% CI: 0.30, 0.76; P = 0.002]. Monocanalicular intubation showed no statistically significant difference when compared with BCI in terms of surgical success and failure; however, MCI had a lower risk of complications (RR = 0.68; 95% CI: 0.48, 0.97; P = 0.04). In addition, STI did not demonstrate any significant difference from BD. CONCLUSION: There was no significant difference in success/failure between MCI and BCI; monocanalicular had fewer complications. Silicone tube intubation did better in terms of surgical success than probing, especially in children over 12 months, suggesting that it is the preferred intervention for older patients with CNLDO.

The Efficacy and Safety of Endoscopic Balloon Dilatation in the Treatment of Functional Post-Sleeve-Gastrectomy Stenosis.

Background and Objectives: Functional gastric stenosis, a consequence of sleeve gastrectomy, is defined as a rotation of the gastric tube along its longitudinal axis. It is brought on by gastric twisting without the anatomical constriction of the gastric lumen. During endoscopic examination, the staple line is deviated with a clockwise rotation, and the stenosis requires additional endoscopic manipulations for its transposition. Upper gastrointestinal series show the gastric twist with an upstream dilatation of the gastric tube in some patients. Data on its management have remained scarce. The objective was to assess the efficacy and safety of endoscopic balloon dilatation in the management of functional post-sleeve gastrectomy stenosis. Patients and Methods: Twenty-two patients with functional post-primary-sleeve-gastrectomy stenosis who had an endoscopic balloon dilatation between 2017 and 2023 were included in this retrospective study. Patients with alternative treatment plans and those undergoing endoscopic dilatation for other forms of gastric stenosis were excluded. The clinical outcomes were used to evaluate the efficacy and safety of balloon dilatation in the management of functional gastric stenosis. Results: A total of 45 dilatations were performed with a 30 mm balloon in 22 patients (100%), a 35 mm balloon in 18 patients (81.82%), and a 40 mm balloon in 5 patients (22.73%). The patients' clinical responses after the first balloon dilatation were a complete clinical response (4 patients, 18.18%), a partial clinical response (12 patients, 54.55%), and a non-response (6 patients, 27.27%). Nineteen patients (86.36%) had achieved clinical success at six months. Three patients (13.64%) who remained symptomatic even after achieving the maximal balloon dilation of 40 mm were considered failure of endoscopic dilatation, and they were referred for surgical intervention. No significant adverse events were found during or following the balloon dilatation. Conclusions: Endoscopic balloon dilatation is an effective and safe minimally invasive procedure in the management of functional post-sleeve-gastrectomy stenosis.

[Puncture dilatation tracheostomy in children during transoral neurosurgical interventions]. / Punktsionnaya dilatatsionnaya trakheostomiya u detei pri transoral'nykh neirokhirurgicheskikh vmeshatel'stvakh.

Neurosurgical interventions within the ventral surface of the clivus and upper cervical vertebrae in childhood are sometimes carried out through transoral approach. In this situation, tracheostomy is safer for airway protection and mechanical ventilation compared to prolonged intubation. The world experience of percutaneous dilation tracheostomy in pediatric patients is limited due to anatomical and physiological features, such as difficult orientation in anatomical landmarks, high mobility of the trachea and small tracheal lumen. Also, the trachea easily collapses when pressed in pediatric patients that complicates safe puncture of anterior wall and can lead to perforation of posterior tracheal wall. OBJECTIVE: To describe a modified technique of video-assisted percutaneous dilation tracheostomy using additional thin guide and dilator in children of primary school age. MATERIAL AND METHODS: We considered 11 patients aged 6-12 years who underwent video-assisted percutaneous dilation tracheostomy. RESULTS: There were no perioperative complications (bleeding, false course, perforation of posterior tracheal wall). Infection of tracheostomy, fistulas or tracheal stenosis was absent. CONCLUSION: Percutaneous dilation tracheostomy may be alternative to classical surgical tracheostomy for pediatric patients. Endoscopic control and certain technical changes of percutaneous tracheostomy are necessary and provide safe manipulation. Surgery time, less trauma and minimal cosmetic defect after tracheostomy are significant advantages of this technique compared to surgical tracheostomy.

Analysis of long-term effect of ureteral balloon dilatation combined with internal and external drainage tube in the treatment of benign ureteral stricture.

PURPOSE: There are few reports about balloon dilatation combined with internal and external drainage tube in the treatment of ureteral stricture under interventional therapy. The aim of the study is to explore the safety, effectiveness and long-term efficacy of this treatment strategy. MATERIALS AND METHODS: It is a retrospective and observational study. From October 2013 to October 2016, 42 patients with benign lower ureteral stricture received interventional treatment. Balloon dilatation combined with internal and external drainage tube implantation were used. There were 25 male patients and 17 female patients. There were 7 cases (16.7%) with congenital ureteral stricture, 12 cases (28.6%) with inflammation, 15 cases (35.7%) with ureteral stricture after lithotomy or lithotripsy, and 8 cases (19.0%) with ureteral stricture after pelvic or abdominal surgery. After the drainage tube was removed, B ultrasound, enhanced CTU or IVP of urinary system were reexamined every six months. The follow-up time was 12-60 months. RESULTS: The age was 52.9 ± 11.6 years. The length of ureteral stricture was 1.1 ± 0.5 cm. 42 patients completed interventional treatment, the technical success rate was 100%, no ureteral perforation, rupture or other complications were identified. Preoperative urea nitrogen 9.2 ± 2.3 mmol/L and creatinine 175.8 ± 82.8umol/L. Urea nitrogen and creatinine were 3.8-9.1 mmol/L and 45.2-189.6 umol/L when removing the drainage tube. There were significant differences in the levels of urea nitrogen and creatinine before and after tube removal (P < 0.05). The ureteral patency rate was 100% at 6 months, 93% at 12 months, 83% at 18 months, 79% at 24 months, 76% at 30 months and 73% at 36-60 months. The overall success rate was 73%. Multivariate Cox regression analysis showed that stenosis length was a risk factor for postoperative patency (P < 0.05). CONCLUSION: Balloon dilatation combined with internal and external drainage tube implantation in the treatment of benign lower ureteral stricture is safe and effective.

Nasal dilator and physiological parameters associated to running performance: A systematic review and meta-analysis.

Nasal dilators were created to expand the nasal valve area. The aim of this systematic review was to verify physiological parameters associated to running performance with the use of nasal dilators. This study was registered in PROSPERO (CRD42021225795). According to the PICOS framework studies were included: Population: healthy subjects; Intervention: nasal dilators; Comparison: control group, placebo, minimal intervention, health education or other intervention; Outcomes: cardiorespiratory parameters and subjective perceptions; Study: randomized controlled trials, repeated measures or within-subjects design. The databases searched were MEDLINE, EMBASE, CENTRAL The Cochrane Library, CINAHL, SPORTDiscus, Web of Science, PEDro and Scopus. The descriptors "Running", "Nasal Dilator", "Randomized Controlled Trial", and synonyms were used. The risk of bias was assessed using the PEDro scale. Random effects Der Simonian and Laird model were used. The assessment of the certainty of the evidence was carried out using the GRADE approach. Eleven articles were included. There was a difference in favour of the nasal dilator when compared to placebo for maximal oxygen uptake and rating of perceived exertion. The certainty of the evidence was very low. Future studies will probably have an impact on estimation of the effect.

Determining the Safety Threshold for the Passage of a Ureteral Access Sheath in Clinical Practice Using a Purpose-Built Force Sensor.

PURPOSE: Ureteral injury is a frequent complication of ureteral access sheath deployment. We sought to define the safe threshold of force for the passage of a ureteral access sheath using a novel ureteral access sheath force sensor. MATERIALS AND METHODS: Ureteral access sheath-force sensor measurements were recorded in 210 renal units. A 16Fr ureteral access sheath was deployed initially based on a prior porcine study. If 6 N was reached, the surgeon was advised to downsize the 16Fr ureteral access sheath. In each case, a post-ureteroscopic lesion scale was recorded. Regression models were used to estimate the impact of adjusted variables on post-ureteroscopic lesion scale grade, 16Fr ureteral access sheath deployment, and peak force. RESULTS: A 16Fr ureteral access sheath was deployed in 127 (61%) renal units with a mean peak force of 5.7 N. Two high-grade ureteral injuries occurred; in both cases >6 N of force was recorded. Post-ureteroscopic lesion scale grade correlated directly with peak insertion force (p <0.01). Bacteriuria within 60 days of the procedure (OR 2.009, p=0.034), combination of preoperative stent plus oral tamsulosin (OR 2.998, p=0.045), and prior ipsilateral stone surgery (OR 2.13, p=0.01) were independent predictors of successful 16Fr ureteral access sheath deployment. Among patients with neither prior ipsilateral stone surgery nor preoperative stent, preoperative tamsulosin facilitated passage of a 16Fr ureteral access sheath (OR 2.750, p=0.034). CONCLUSIONS: Ureteral access sheath associated ureteral injury can be averted by limiting the insertion force to ≤6 N. Prior stone surgery, preoperative indwelling ureteral stent plus oral tamsulosin, and recently treated bacteriuria favored passage of a 16Fr ureteral access sheath. In the naïve, unstented patient, preoperative tamsulosin favored deployment of a 16Fr ureteral access sheath.

Ureteral Stent Encrustation: Epidemiology, Pathophysiology, Management and Current Technology.

PURPOSE: Encrustation is a common phenomenon that can occur following placement of a ureteral stent into the urinary tract, and it can lead to serious complications. The following review addresses the mechanism of encrustation, the management of these stents and the newest technology developed to mitigate this issue. MATERIALS AND METHODS: We performed a comprehensive literature search on stent encrustation including peer-reviewed publications, public product listings, and material on current and future stent technology. RESULTS: The mechanism of encrustation is complex and multifaceted, including dwell time, patient specific risk factors, conditioning film formation, biofilm formation and mineral deposition. Several technological developments in stent materials and coatings may have a role in reducing the risk of stent encrustation. It is important to identify the extent of stent encrustation and plan treatment strategies accordingly. We propose a novel treatment algorithm for the management encrusted ureteral stents. CONCLUSIONS: The ubiquity of ureteral stents in urology practice mandates updated knowledge about the prevention of stent encrustation, identification of high risk patients and preparedness for removal using multimodal techniques.

Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial.

BACKGROUND: We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. METHODS: open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18-75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. RESULTS: the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37). CONCLUSIONS: there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment. TRIAL REGISTRATION: Brazilian Registry of Clinical Trials, RBR-23w5fv . Registered 10 January 2017 - Retrospectively registered.

Endoscopic Biliary Large Balloon Dilation Lithotripsy for Giant and Impacted Stones Removal: A Western Series.

BACKGROUND: Endoscopic removal of packed, large, or impacted stones, in which a basket cannot be deployed or is unable to grasp the stone(s), is challenging and inevitably leads to repeated procedures such as stent insertion and extra- or intracorporal lithotripsy. In this study, we describe the results of an alternative stone disintegration technique in a considerable series of patients using an esophageal/pyloric balloon for stone fragmentation or making working space in the bile duct to allow the deployment of the basket, a technique we call endoscopic biliary large balloon lithotripsy. METHODS: We retrieved data from 1,429 endoscopic retrograde cholangiopancreatographies (ERCPs) from 2 prospective trials performed between 2014 and 2019. Patients with difficult bile duct stones, in which a balloon dilator up to 15 mm was used to crush or increase the working space parallel to the stones in the common or hepatic duct, were included in the study. RESULTS: From the 1,429 ERCPs, 299 had difficult stones (>1 cm, impacted or multiple stones). Large balloon lithotripsy was employed in 46 cases after endoscopic papillotomy and endoscopic biliary large balloon dilation with failed attempted balloon or basket stone(s) extraction. Failure to clear the bile duct at first ERCP occurred in 4 cases (91.3% of success). Complications were observed in 5 patients (10.8%; 1 perforation, 1 pancreatitis, and 3 bleedings), who were treated conservatively. CONCLUSIONS: Large balloon lithotripsy, in order to crush the stones or make working room for baskets or balloons in the bile duct, is an effective, safe, and low cost technique for impacted, packed, or giant bile duct stones.

Safety of percutaneous dilatational tracheotomy (PDT) with the rigid tracheotomy endoscope (TED): a 6-month follow-up multicenter investigation.

BACKGROUND: The rigid tracheotomy endoscope (TED) was recently introduced to improve the fiberoptic technique during percutaneous dilatational tracheotomy (PDT) in critically ill patients. The aim was to evaluate the long-term complications of PDT using TED equipment in a prospective multicenter investigation. METHODS: One hundred eighty adult patients underwent PDT using TED in four German hospitals. Patients who were alive or their guardians were contacted via telephone and interviewed using a structured questionnaire 6 months following the tracheostomy procedure. Patients with airway complaints were invited for outpatient clinical ENT examination. The incidence of adverse events related to PDT was registered. RESULTS: Of 180 patients who received tracheostomy, 137 (76.1%) were alive at the time of follow-up. None of the 43 lethal events was related to the PDT. Fifty-three (38.7%) patients were available for follow-up examination, whereas 14 (10.2%) were able to visit ENT physicians. Two (3.8%) out of 53 patients developed tracheocutaneous fistula with required surgical closure of tracheostoma. Dyspnea (7.5%), hoarseness (5.7%), stridor and swallowing difficulties (both with 3.8%) were the most common complaints. Tracheal stenosis was confirmed in 1 patient (1.88% [95% CI: 0.33; 9.93]). CONCLUSION: The use of TED for PDT in the clinical setting is safe regarding adverse events at 6-month follow-up. The incidence of tracheal stenosis after PDT with TED is comparable with that of flexible bronchoscopy; however, its role for PDT at the intensive care unit should be clarified in further investigations.

A Prospective Randomized Controlled Trial of Irrigation "Bag Squeeze" to Manage Pain for Patients Undergoing Flexible Cystoscopy.

PURPOSE: We determined if the "bag squeeze" technique decreases pain during flexible cystoscopy in men. MATERIALS AND METHODS: This single center, prospective, double-blind, randomized controlled trial recruited 200 consenting participants who were ambulatory, outpatient males who had undergone prior cystoscopy and were not expected to require any secondary procedures. Men with prior urethral stricture or bladder neck contracture were excluded from study. Once eligibility was assessed and consent obtained, participants were randomized to undergo cystoscopy with the bag squeeze (group A) or the sham bag squeeze procedure (group B). Following cystoscopy, participants completed a pain questionnaire (visual analogue scale). Differences in mean pain score between groups were evaluated using Students' t-test with a 2-sided alpha of 0.05. RESULTS: A total of 200 patients were randomized and underwent flexible cystoscopy. Ten participants were ineligible because they required secondary procedures. Among the 190 eligible patients 97 were randomized to bag squeeze (group A) and 93 to sham bag squeeze (group B) with mean pain scores of 1.91 and 3.39, respectively (p <0.005). CONCLUSIONS: This study demonstrated a clinically meaningful decrease in pain for men undergoing flexible cystoscopy when the irrigation bag squeeze technique was used vs placebo bag squeeze. Accordingly, this useful, simple and free method to improve patient comfort during flexible cystoscopy should be adopted by clinicians.

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.