Peroral endoscopic myotomy versus pneumatic dilation in treatment-naive patients with achalasia: 5-year follow-up of a randomised controlled trial.

BACKGROUND: 2-year follow-up data from our randomised controlled trial showed that peroral endoscopic myotomy is associated with a significantly higher efficacy than pneumatic dilation as initial treatment of therapy-naive patients with achalasia. Here we report therapeutic success rates in patients treated with peroral endoscopic myotomy compared with pneumatic dilation at the 5-year follow-up. METHODS: We did a multicentre, randomised controlled trial in six hospitals in the Netherlands, Germany, Italy, Hong Kong, and the USA. Adults aged 18-80 years with newly diagnosed symptomatic achalasia (based on an Eckardt score >3) were eligible for inclusion. Patients were randomly assigned (1:1) to peroral endoscopic myotomy or pneumatic dilation using web-based randomisation with a random block size of 8 and stratification according to site. Randomisation concealment for treatment type was double blind until official study enrolment. Treatment was unmasked because of the different technical approach of each procedure. Patients in the pneumatic dilation group were dilated with a single series of 30-35 mm balloons. The need for subsequent dilations in the pneumatic dilation group, and the need for dilation after initial treatment in the peroral endoscopic myotomy group, was considered treatment failure. The primary outcome was therapeutic success (Eckardt score ≤3 in the absence of severe treatment-related complications and no need for retreatment). Analysis of the primary outcome was by modified intention to treat, including all patients randomly assigned to a group, excluding those patients who did not receive treatment or were lost to follow-up. Safety was assessed in all included patients. This study is registered at the Dutch Trial Registry, NTR3593, and is completed. FINDINGS: Between Sept 21, 2012, and July 20, 2015, 182 patients were assessed for eligibility, 133 of whom were included in the study and randomly assigned to peroral endoscopic myotomy (n=67) or pneumatic dilation (n=66). 5-year follow-up data were available for 62 patients in the peroral endoscopic myotomy group and 63 patients in the pneumatic dilation group. 50 (81%) patients in the peroral endoscopic myotomy group had treatment success at 5 years, compared with 25 (40%) in the pneumatic dilation group, an adjusted absolute difference of 41% (95% CI 25-57; p<0·0001). Reasons for failure were no initial effect of treatment (one patient in the peroral endoscopic myotomy group vs 12 patients in the pneumatic dilation group) and recurrent symptoms causing treatment failure (11 patients in the peroral endoscopic myotomy group [seven patients between 2 and 5 years] vs 25 patients in the pneumatic dilation group [nine patients between 2 and 5 years]); one patient in the pneumatic dilation group had treatment failure due to an adverse event. Proton-pump inhibitor use (mostly daily) was significantly higher after peroral endoscopic myotomy than after pneumatic dilation among patients still in clinical remission (23 [46%] of 50 patients vs three [13%] of 24 patients; p=0·008). 5-year follow-up endoscopy of patients still in clinical remission showed reflux oesophagitis in 14 (33%) of 42 patients in the peroral endoscopic myotomy group (12 [29%] grade A or B, two [5%] grade C or D) and two (13%) of 16 patients in the pneumatic dilation group (two [13%] grade A or B, none grade C or D; p=0·19). No intervention-related serious adverse events occurred between 2 and 5 years after treatment. The following non-intervention-related serious adverse events occurred between 2 and 5 years: a stroke (one [2%]) in the peroral endoscopic myotomy group; and death due to a melanoma (one [2%]) and dementia (one [2%]) in the pneumatic dilation group. INTERPRETATION: Based on this study, peroral endoscopic myotomy should be proposed as an initial treatment option for patients with achalasia. Although our study has shown that peroral endoscopic myotomy has greater long-term efficacy with a low risk of major treatment-related complications, this should not lead to abandonment of pneumatic dilation from clinical practice. Ideally, all treatment options should be discussed with treatment-naive patients with achalasia and a shared decision should be made. FUNDING: Fonds NutsOhra and European Society of Gastrointestinal Endoscopy.

The Vertical Rectus Abdominis Myocutaneous Flap to Manage Vaginal Evisceration.

BACKGROUND: Pelvic organ prolapse (POP) is a significant issue requiring surgical correction in 19% of the female population by age 85 years. Complications of POP, especially in women who have undergone hysterectomy, include vaginal evisceration-a serious complication that carries high morbidity and mortality rates. Rarely, vaginal evisceration occurs after colpocleisis. CASE: A 69-year-old female with recurrent vaginal evisceration following colpocleisis underwent surgical repair using a vertical rectus abdominis myocutaneous (VRAM) flap. CONCLUSION: Recurrent cases of POP and vaginal evisceration that are refractory to conventional treatment require consideration of novel management options. To our knowledge, this is the first case using a VRAM flap for the management of vaginal evisceration.

Implementation of the Synergy Tool: A Potential Intervention to Relieve Health Care Worker Burnout.

(1) Background: Healthcare workers experienced rising burnout rates during and after the COVID-19 pandemic. A practice-academic collaboration between health services researchers and the surgical services program of a Canadian tertiary-care urban hospital was used to develop, implement and evaluate a potential burnout intervention, the Synergy tool. (2) Methods: Using participatory action research methods, this project involved four key phases: (I) an environmental scan and a baseline survey assessment, (II), a workshop, (III) Synergy tool implementation and (IV) a staffing plan workshop. A follow-up survey to evaluate the impact of Synergy tool use on healthcare worker burnout will be completed in 2023. (3) Results: A baseline survey assessment indicated high to severe levels of personal and work-related burnout prior to project initiation. During the project phases, there was high staff engagement with Synergy tool use to create patient care needs profiles and staffing recommendations. (4) Conclusions: As in previous research with the Synergy tool, this patient needs assessment approach is an efficient and effective way to engage direct care providers in identifying and scoring acuity and dependency needs for their specific patient populations. The Synergy tool approach to assessing patient needs holds promise as a means to engage direct care providers and to give them greater control over their practice-potentially serving as a buffer against burnout.

How do public libraries respond to patron queries about opioid use disorder? A secret shopper study.

Background: Improving linkage to opioid use disorder (OUD) treatment and services is a public health priority. Public libraries, a community resource for health information, may be well positioned to support and guide people who use drugs, as well as their families and friends. In this study, we sought to evaluate the availability and types of resources offered to patrons inquiring about OUD information, OUD treatment, and naloxone access. Methods: We conducted an audit (secret shopper) study from April 2019 to June 2019 in which an auditor anonymously called Pennsylvania public libraries. We used a purposive sampling strategy to select libraries located in geographically diverse regions across the urban-rural continuum. We categorized responses and verified via phone or website whether referrals to treatment centers and other organizations provided OUD treatment or services. Results: We obtained responses from 100 public libraries located across 48 of the 67 counties in Pennsylvania. Among the libraries that responded, 57 provided health information resources (e.g., books, websites) and 82 provided "next step" referrals to an organization that could provide further assistance. Among the libraries that provided referrals, 39 were to treatment centers, of which 33 were specifically to treatment centers that offer medications for OUD. Of the responding libraries, 28 communicated information about naloxone access. Conclusion: Public libraries can and do connect patrons to OUD treatment and support services; however, there is wide interlibrary variation in the resources presented, demonstrating opportunities for improvement in how libraries engage and refer patrons with substance use needs.

Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study.

PURPOSE: Current FDA-approved imaging modalities are inadequate for localizing prostate cancer biochemical recurrence (BCR). 18F-DCFPyL is a highly selective, small-molecule prostate-specific membrane antigen-targeted PET radiotracer. CONDOR was a prospective study designed to determine the performance of 18F-DCFPyL-PET/CT in patients with BCR and uninformative standard imaging. EXPERIMENTAL DESIGN: Men with rising PSA ≥0.2 ng/mL after prostatectomy or ≥2 ng/mL above nadir after radiotherapy were eligible. The primary endpoint was correct localization rate (CLR), defined as positive predictive value with an additional requirement of anatomic lesion colocalization between 18F-DCFPyL-PET/CT and a composite standard of truth (SOT). The SOT consisted of, in descending priority (i) histopathology, (ii) subsequent correlative imaging findings, or (iii) post-radiation PSA response. The trial was considered a success if the lower bound of the 95% confidence interval (CI) for CLR exceeded 20% for two of three 18F-DCFPyL-PET/CT readers. Secondary endpoints included change in intended management and safety. RESULTS: A total of 208 men with a median baseline PSA of 0.8 ng/mL (range: 0.2-98.4 ng/mL) underwent 18F-DCFPyL-PET/CT. The CLR was 84.8%-87.0% (lower bound of 95% CI: 77.8-80.4). A total of 63.9% of evaluable patients had a change in intended management after 18F-DCFPyL-PET/CT. The disease detection rate was 59% to 66% (at least one lesion detected per patient by 18F-DCFPyL-PET/CT by central readers). CONCLUSIONS: Performance of 18F-DCFPyL-PET/CT achieved the study's primary endpoint, demonstrating disease localization in the setting of negative standard imaging and providing clinically meaningful and actionable information. These data further support the utility of 18F-DCFPyL-PET/CT to localize disease in men with recurrent prostate cancer.See related commentary by True and Chen, p. 3512.

A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY).

PURPOSE: Prostate specific membrane antigen-targeted positron emission tomography/computerized tomography has the potential to improve the detection and localization of prostate cancer. OSPREY was a prospective trial designed to determine the diagnostic performance of 18F-DCFPyL-positron emission tomography/computerized tomography for detecting sites of metastatic prostate cancer. MATERIALS AND METHODS: Two patient populations underwent 18F-DCFPyL-positron emission tomography/computerized tomography. Cohort A enrolled men with high-risk prostate cancer undergoing radical prostatectomy with pelvic lymphadenectomy. Cohort B enrolled patients with suspected recurrent/metastatic prostate cancer on conventional imaging. Three blinded central readers evaluated the 18F-DCFPyL-positron emission tomography/computerized tomography. Diagnostic performance of 18F-DCFPyL-positron emission tomography/computerized tomography was based on imaging results compared to histopathology. In cohort A, detection of pelvic nodal disease (with specificity and sensitivity as co-primary end points) and of extrapelvic metastases were evaluated. In cohort B, sensitivity and positive predictive value for prostate cancer within biopsied lesions were evaluated. RESULTS: A total of 385 patients were enrolled. In cohort A (252 evaluable patients), 18F-DCFPyL-positron emission tomography/computerized tomography had median specificity of 97.9% (95% CI: 94.5%-99.4%) and median sensitivity of 40.3% (28.1%-52.5%, not meeting prespecified end point) among 3 readers for pelvic nodal involvement; median positive predictive value and negative predictive value were 86.7% (69.7%-95.3%) and 83.2% (78.2%-88.1%), respectively. In cohort B (93 evaluable patients, median prostate specific antigen 11.3 ng/ml), median sensitivity and positive predictive value for extraprostatic lesions were 95.8% (87.8%-99.0%) and 81.9% (73.7%-90.2%), respectively. CONCLUSIONS: The primary end point for specificity was met while the primary end point for sensitivity was not. The high positive predictive value observed in both cohorts indicates that 18F-DCFPyL-positive lesions are likely to represent disease, supporting the potential utility of 18F-DCFPyL-positron emission tomography/computerized tomography to stage men with high-risk prostate cancer for nodal or distant metastases, and reliably detect sites of disease in men with suspected metastatic prostate cancer.

Correlation between translabial ultrasound parameters and outcomes in retropubic mid-urethral slings: can we predict success?

PURPOSE: The aim of this study was to assess the association between four-dimensional translabial ultrasound (4D-TLUS) features of the retropubic mid-urethral sling (MUS) and post-operative pelvic floor symptoms. METHODS: A prospective cohort study was performed involving 100 women who had a solitary retropubic MUS (TVT Exact™) between Jan 2013 and Dec 2017 for urodynamic stress incontinence (SI) at a tertiary urogynaecological centre. All patients completed a standardised interview and had free flowmetry, prolapse evaluation and assessment for mesh exposure and tenderness. 4D-TLUS parameters measured included pelvic organ descent, levator ani status, sling-symphysis pubis (SP) gap at rest and Valsalva, angle formed by cranial and caudal ends of the sling, cranio-caudal and dorso-ventral sling-symphysis pubis distance at Valsalva. The primary outcome was treatment success as defined by patient report of cure or improvement and no objective demonstrable SI. RESULTS: Eighty-nine (89%) patients reported treatment success. Two patients (2%) had mesh exposure; one was symptomatic with pain, requiring complete sling removal. There was a significant association between treatment success and a SP gap at Valsalva of 10-12 mm (p = 0.001); and independently with a SP angle at Valsalva of 45°-80° (p = 0.007). A narrower SP gap at Valsalva closer to 10 mm was associated with voiding symptoms (p = 0.036). CONCLUSION: Sling-pubis gap and sling-pubis angle at Valsalva appear to be significantly associated with treatment success in retropubic MUS. There is a significant association between a narrower sling-pubis gap at Valsalva and voiding symptoms.

A Real-world Experience of the Safety and Efficacy of Non-vitamin K Oral Anticoagulants Versus Warfarin in Patients with Non-valvular Atrial Fibrillation-A Single-centre Retrospective Cohort Study in Singapore.

INTRODUCTION: Non-vitamin K oral anticoagulants (NOACs) were shown to have better outcomes than warfarin for non-valvular atrial fibrillation (NVAF). Given limited local real-world data, this study aims to evaluate the safety and efficacy of NOACs versus warfarin for NVAF in Singapore. METHODS: This single-centre retrospective cohort study included 439 patients ≥ 21 years old that were newly prescribed with oral anticoagulants (OACs) for NVAF in 2015. Follow-ups for patients upon OAC initiation lasted either for 2 years or until the occurrence of bleeding or thromboembolism event or death (whichever was earlier). Primary endpoints included major bleeding and stroke, while secondary endpoints included overall bleeding and thromboembolic events. Time-to-events was evaluated via Kaplan-Meier survival analysis. Data on time in therapeutic range (TTR) and compliance were analysed. RESULTS: Patients were assigned to 4 groups: warfarin (157, 35.8%), rivaroxaban (154, 35.1%), apixaban (98, 22.3%) and dabigatran (30, 6.8%). With a mean age of 70.8 (±10.8) years old, the population were predominantly males (56.5%) and comprised Chinese (73.8%), Malays (18.7%) and others (7.5%). The rates of stroke per year were 0.7%, 1.7%, 2.2% and 0% for warfarin, rivaroxaban, apixaban and dabigatran, respectively (P=0.411), whereas those of major bleeding were 2.7%, 1.4%, 2.2% and 0% (P=0.560). As compared to warfarin, no significant differences were observed for risks of stroke and of major bleeding for rivaroxaban (adjusted hazard ratio (HR) 4.19, 95% confidence interval (CI) 0.68-26.05, P=0.124 and adjusted HR 0.43, 95% CI 0.12-1.59, P=0.207) and apixaban (adjusted HR 5.33, 95% CI 0.85-33.34, P=0.074 and adjusted HR 1.54, 95% CI 0.39-6.15, P=0.538). Mean TTR was 68.8% (±24.3%) for warfarin. Compliance rates for rivaroxaban, apixaban, and dabigatran were 56.6%, 59.2%, and 44.8%, respectively (P=0.177). CONCLUSION: NOACs were associated with similar stroke and major bleeding rates as warfarin for NVAF.

Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) has become the mainstay for the treatment of achalasia at many institutions around the world since its inception in 2008. POEM can be performed using either the anterior or posterior approach. The primary aim of this study was to compare the efficacy of the anterior and posterior approaches at 1 year after POEM. METHODS: This is a single-blinded, randomized, noninferiority international clinical trial. Eligible participants were adult patients with a confirmed diagnosis of achalasia via high-resolution esophageal manometry. Patients were randomly allocated with a 1:1 ratio to receive POEM with anterior or posterior approach. The primary aim was to compare the rate of clinical success (Eckardt score <3) of anterior and posterior approaches at 1 year. RESULTS: One hundred fifty patients were randomized to receive either anterior (n = 73) or posterior (n = 77) POEM. One hundred forty-eight patients received the POEM treatment, and 138 patients completed the 1-year follow-up and were included in the primary efficacy analysis. Technical success was achieved in 71 patients (97.3%) in the anterior group versus 77 patients (100%) in the posterior group (P = .23). The median (interquartile range) length of hospital stay after the procedure was 2 (1-3) days for both groups. Adverse events occurred in 15 patients (10%), 8 patients (11%) in the anterior group and 7 patients (9%) in the posterior group (P = .703). Clinical success was achieved in 90% of patients in the anterior group and 89% of patients in the posterior group. Abnormal esophageal acid exposure was detected in 29 of 59 patients (49%) and 25 of 60 patients (42%) in the anterior and posterior groups, respectively (P = .67). GERD questionnaire scores were also not significantly different between the study groups. In both groups, quality of life improved after POEM for all 36-Item Short-Form Health Survey measures and was similar between both groups. CONCLUSIONS: Posterior myotomy during POEM was not inferior to anterior myotomy in terms of efficacy and safety in the treatment of patients with achalasia. (Clinical trial registration number: NCT02454335.).

Online Reviews of Specialized Drug Treatment Facilities-Identifying Potential Drivers of High and Low Patient Satisfaction.

BACKGROUND: Despite the importance of high-quality and patient-centered substance use disorder treatment, there are no standardized ratings of specialized drug treatment facilities and their services. Online platforms offer insights into potential drivers of high and low patient experience. OBJECTIVE: We sought to analyze publicly available online review content of specialized drug treatment facilities and identify themes within high and low ratings. DESIGN: This was a retrospective analysis of online ratings and reviews of specialized drug treatment facilities in Pennsylvania listed within the 2016 National Directory of Drug and Alcohol Abuse Treatment Facilities. Latent Dirichlet Allocation, a machine learning approach to narrative text, was used to identify themes within reviews. Differential Language Analysis was then used to measure correlations between themes and star ratings. SETTING: Online reviews of Pennsylvania's specialized drug treatment facilities posted to Google and Yelp (July 2010-August 2018). RESULTS: A total of 7823 online ratings were posted over 8 years. The distribution was bimodal (43% 5-star and 34% 1-star). The average weighted rating of a facility was 3.3 stars. Online themes correlated with 5-star ratings were the following: focus on recovery (r = 0.53), helpfulness of staff (r = 0.43), compassionate care (r = 0.37), experienced a life-changing moment (r = 0.32), and staff professionalism (r = 0.29). Themes correlated with a 1-star rating were waiting time (r = 0.41), poor accommodations (0.26), poor phone communication (r = 0.24), medications given (0.24), and appointment availability (r = 0.23). Themes derived from review content were similar to 9 of the 14 facility-level services highlighted by the Substance Abuse and Mental Health Services Administration's National Survey of Substance Abuse Treatment Services. CONCLUSIONS: Individuals are sharing their ratings and reviews of specialized drug treatment facilities on online platforms. Organically derived reviews of the patient experience, captured by online platforms, reveal potential drivers of high and low ratings. These represent additional areas of focus which can inform patient-centered quality metrics for specialized drug treatment facilities.

Studying expressions of loneliness in individuals using twitter: an observational study.

OBJECTIVES: Loneliness is a major public health problem and an estimated 17% of adults aged 18-70 in the USA reported being lonely. We sought to characterise the (online) lives of people who mention the words 'lonely' or 'alone' in their Twitter timeline and correlate their posts with predictors of mental health. SETTING AND DESIGN: From approximately 400 million tweets collected from Twitter in Pennsylvania, USA, between 2012 and 2016, we identified users whose Twitter posts contained the words 'lonely' or 'alone' and compared them to a control group matched by age, gender and period of posting. Using natural-language processing, we characterised the topics and diurnal patterns of users' posts, their association with linguistic markers of mental health and if language can predict manifestations of loneliness. The statistical analysis, data synthesis and model creation were conducted in 2018-2019. PRIMARY OUTCOME MEASURES: We evaluated counts of language features in the users with posts including the words lonely or alone compared with the control group. These language features were measured by (a) open-vocabulary topics, (b) Linguistic Inquiry Word Count (LIWC) lexicon, (c) linguistic markers of anger, depression and anxiety, and (d) temporal patterns and number of drug words. Using machine learning, we also evaluated if expressions of loneliness can be predicted in users' timelines, measured by area under curve (AUC). RESULTS: Twitter timelines of users (n=6202) with posts including the words lonely or alone were found to include themes about difficult interpersonal relationships, psychosomatic symptoms, substance use, wanting change, unhealthy eating and having troubles with sleep. Their posts were also associated with linguistic markers of anger, depression and anxiety. A random forest model predicted expressions of loneliness online with an AUC of 0.86. CONCLUSIONS: Users' Twitter timelines with the words lonely or alone often include psychosocial features and can potentially have associations with how individuals express and experience loneliness. This can inform low-resource online assessment for high-risk individuals experiencing loneliness and interventions focused on addressing morbidities in this condition.

A pilot study on surgical reduction of the levator hiatus-the puborectalis sling.

INTRODUCTION AND HYPOTHESIS: Female pelvic organ prolapse recurrence has been shown to be associated with levator hiatal distensibility. Reducing hiatal size surgically may reduce recurrence risk. This study aims to demonstrate a novel surgical procedure, the puborectalis sling (PR sling), designed to reduce the levator hiatal area, and to assess the medium-term safety and efficacy of this procedure. METHODS: One hundred fifteen women undergoing prolapse repair with a pre-operative hiatal area on Valsalva of ≥ 35 cm2 were recruited into this phase 1 prospective multicentre pilot study. All underwent a PR sling procedure after completion of standard repairs. Primary outcome was levator hiatal area measured on ultrasound. RESULTS: One hundred ten patients were evaluated at least 3 months post-operatively. At 2.5 years average follow-up, there was an average of 12 cm2 (range 6-16 cm2) reduction in hiatal area from a mean pre-operative hiatal area of 43.9 (35-63) cm2. Thirty per cent (28/93) were symptomatic of prolapse, 66% (61/93) had clinical prolapse recurrence whilst 49% (46/93) had sonographic recurrence. Three patients required a return to theatre; one case of infection resulted in mesh removal, one had severe obstructed defecation requiring sling loosening and another had buttock pain with faecal impaction that resolved after manual disimpaction. There were no long-term sequelae. CONCLUSIONS: The levator hiatal area can be reduced surgically, with almost 30% reduction in area seen in this pilot study. The reduction was significant and sustained up to 2 years with no major long-term complications.

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.

Pelvic floor ultrasound findings in Ugandan women with obstetric fistula, unrepaired fourth degree obstetric tear, and pelvic organ prolapse.

BACKGROUND: While pelvic floor ultrasound is commonly utilised in high-resource locations, our understanding of pelvic floor characteristics in women suffering with obstetric fistula and unrepaired fourth degree obstetric tears in low-resource areas is limited. AIMS: This study aimed to assess the pelvic floor ultrasound characteristics of Ugandan women suffering with obstetric fistula, unrepaired fourth degree obstetric tears and pelvic organ prolapse, and determine whether obstructed labour resulting in obstetric fistula causes more levator muscle defects compared to parous women without a history of obstructed labour. MATERIALS AND METHODS: This was a prospective study in western Uganda assessing 82 women with obstetric fistula, unrepaired fourth degree obstetric tears and pelvic organ prolapse with a pelvic floor ultrasound scan. RESULTS: Demographic characteristics were significantly different, with women suffering pelvic organ prolapse being older and more parous. Hiatal area on Valsalva was significantly smaller in the obstetric fistula group (mean 21.45 cm2 ) compared to non-obstetric fistula group (unrepaired fourth degree obstetric tears and pelvic organ prolapse; mean 30.44 cm2 ); a mean difference of 9.0 cm2 (95% CI: 5.4-12.6 cm2 , P < 0.001). Overall, levator muscle defects were significantly more common in women with obstetric fistula (66.7%) compared to the non-obstetric fistula group (44.7%) with P = 0.048; however, there were no significant differences in complete levator muscle defects between obstetric fistula (28.6%) and non-obstetric fistula (23.7%). CONCLUSIONS: Increased hiatal area on Valsalva was noted in the non-obstetric fistula group compared to women with obstetric fistula; however, there were no differences in proportions of complete levator muscle defects.

Per oral endoscopic tumor (POET) resection for treatment of upper gastrointestinal subepithelial tumors.

BACKGROUND: Endoscopic submucosal tunneling has evolved to allow endoscopic resection of subepithelial tumors of gastrointestinal tract without full-thickness perforation. This study aimed to investigate safety and efficacy of submucosal tunnel resection for these tumors. METHOD: Patients with subepithelial tumors (SET) located in esophagus, gastric cardia, lesser curvature, and antrum were recruited. The size of tumor was limited to < 40 mm. The procedures were performed under general anesthesia. A mucosal entrance was created 2 cm proximal to the SET after submucosal injection. Submucosal tunnel was then extended and the tumor was dissected and mobilized with intact overlying mucosa. After complete dissection, the tumors would be retrieved per orally and mucosal entrance closed by endoclips. RESULTS: From June 2012 to December 2016, 51 patients with subepithelial tumors received POET. 39 patients had SET in stomach, 11 located in esophagus, and 1 in duodenum. The mean operative time was 90.46 ± 46.49 min, while the mean size of the tumors was 20.71 ± 14.05 mm. The POET was converted to endoscopic full-thickness resection (EFTR) in three patients with gastric subepithelial tumors located at greater curvature. The overall complication rate was 4.0%, and there was no bleeding, mucosal dehiscence, or leakage. The time to resume diet was 1.7 days, while the average hospital stay was 3.2 ± 1.0 days. The mean follow-up period was 19 ± 16 months, and only 1 patient developed recurrence of leiomyoma. CONCLUSION: Per oral endoscopic tumor resection is safe and effective treatment for esophageal and gastric SET located at cardia, lesser curvature, and antrum. Currently, POET for treatment of upper GI SET is limited by the size and location of the tumor.

Efficacy and Safety of High-Specific-Activity 131I-MIBG Therapy in Patients with Advanced Pheochromocytoma or Paraganglioma.

Patients with metastatic or unresectable (advanced) pheochromocytoma and paraganglioma (PPGL) have poor prognoses and few treatment options. This multicenter, phase 2 trial evaluated the efficacy and safety of high-specific-activity 131I-meta-iodobenzylguanidine (HSA 131I-MIBG) in patients with advanced PPGL. Methods: In this open-label, single-arm study, 81 PPGL patients were screened for enrollment, and 74 received a treatment-planning dose of HSA 131I-MIBG. Of these patients, 68 received at least 1 therapeutic dose (∼18.5 GBq) of HSA 131I-MIBG intravenously. The primary endpoint was the proportion of patients with at least a 50% reduction in baseline antihypertensive medication use lasting at least 6 mo. Secondary endpoints included objective tumor response as assessed by Response Evaluation Criteria in Solid Tumors version 1.0, biochemical tumor marker response, overall survival, and safety. Results: Of the 68 patients who received at least 1 therapeutic dose of HSA 131I-MIBG, 17 (25%; 95% confidence interval, 16%-37%) had a durable reduction in baseline antihypertensive medication use. Among 64 patients with evaluable disease, 59 (92%) had a partial response or stable disease as the best objective response within 12 mo. Decreases in elevated (≥1.5 times the upper limit of normal at baseline) serum chromogranin levels were observed, with confirmed complete and partial responses 12 mo after treatment in 19 of 28 patients (68%). The median overall survival was 36.7 mo (95% confidence interval, 29.9-49.1 mo). The most common treatment-emergent adverse events were nausea, myelosuppression, and fatigue. No patients had drug-related acute hypertensive events during or after the administration of HSA 131I-MIBG. Conclusion: HSA 131I-MIBG offers multiple benefits, including sustained blood pressure control and tumor response in PPGL patients.

Endoscopic suturing for management of peptic ulcer-related upper gastrointestinal bleeding: a preliminary experience.

Background and study aims Acute non-variceal upper gastrointestinal bleeding (UGIB) due to peptic ulcer disease (PUD) remains a common and challenging emergency managed by gastroenterologists. The proper role of endoscopic suturing on the management of PUD-related UGIB is unknown. Patients and methods This is an international case series of patients who underwent endoscopic suturing for bleeding PUD. Primary outcome was rate of immediate hemostasis and rate of early rebleeding (within 72 hours). Secondary outcomes included technical success, delayed rebleeding (> 72 hours), and rate of adverse events (AEs). Results Ten patients (mean age 66.7 years, 30 % female) were included in this study. Nine (90 %) had prior failed endoscopy hemostasis with an average of 1.4 ±â€Š0.7 (range 1 - 3) prior endoscopic sessions. Forrest classification was Ib in 5 (50 %), IIa in 3 (30 %), IIb in 1(10 %), and IIc in 1 (10 %). Mean suturing time was 13.4 ±â€Š5.6 (range 3.5 to 20) minutes. Technical success was 100 %. Rate of immediate hemostasis was 100 % and rate of early rebleeding was 0 %. Mean number of sutures was 1.5 (range, 1 - 4). No AEs were observed. Delayed recurrent bleeding was not observed in any cases after a median of 11 months (range 2 - 56), after endoscopic suturing. Conclusions Oversewing of a bleeding or high-risk ulcer using endoscopic suturing appears to be a safe and effective method for achieving endoscopic hemostasis. It may be considered as rescue endoscopic therapy when primary endoscopic hemostasis fails to control the bleeding or when hemorrhage recurs after successful control of bleeding.