"Just for pregnant women, not for you": a qualitative evaluation of the sexual and reproductive healthcare experiences of transgender and gender diverse cancer survivors.

PURPOSE: To identify opportunities to improve sexual and reproductive health (SRH) care for transgender and gender diverse (TGD) cancer survivors by describing (1) challenges experienced when navigating SRH care and (2) strategies to help overcome these challenges. METHODS: We enrolled a purposive sample of 17 adult TGD cancer survivors and 5 co-survivors. We aimed for a diverse sample across cancer experience, age, racial/ethnic background, sexual orientation, and gender identity. We conducted 90-min individual interviews via videoconference and used reflexive thematic analysis, guided by a focus on three social determinants of health. RESULTS: Themes describing challenges were as follows: (1) Cancer treatment's impact on sexual health was insufficiently addressed by cancer care providers; (2) fertility-related information and conversations were complicated by gendered expectations and ultimately did not meet survivors' needs; (3) feeling excluded and uncared-for in healthcare settings due to gendered language and lack of supportive services that met their needs; and (4) TGD survivors commonly reported high financial burden, negatively impacting their access to care. Strategies to overcome these challenges were (1) a solid social support network that can be integrated into the care team to meet the unique SRH needs of TGD survivors and (2) gender-affirming healthcare providers and environments to address SRH care needs and concerns. CONCLUSIONS: TGD survivors and co-survivors desire improved access to gender-affirming SRH care in cancer survivorship. IMPLICATIONS FOR CANCER SURVIVORS: Key opportunities to improve gender-affirming SRH care in cancer survivorship include fostering and engaging TGD survivors' support networks and implementing system-level changes in cancer care settings.

Patient perceptions underlying ctDNA molecular surveillance for HPV(+) oropharyngeal squamous cell carcinoma.

OBJECTIVE: Circulating tumor DNA assays have robust potential as molecular surveillance tools. They may also exacerbate patient distress without improving outcomes. We investigate patient acceptability of a validated ctHPVDNA assay (NavDx) during cancer surveillance for HPV(+) oropharyngeal cancer (OPC). METHODS: Consented HPV(+) OPC participants completed the NCCN Distress Thermometer, the Hospital Anxiety Depression Scale (HADS), and the Functional Assessment of Cancer Therapy-General (FACT-G) scale both (1) before NavDx blood draw, and (2) after results were provided. Patients then completed a series of focused questions related to their perceptions of the assay. RESULTS: Overall, 55 patients completed the study, with 98.2 % showing no recurrence. For the NCCN Distress Thermometer, median patient distress decreased (2.0 (IQR 1-5) vs. 1.0 (IQR 0-3)) (p < 0.001) in association with NavDx. Using scores ≥ 4 as a cutoff point to define clinically elevated distress, scores also improved (36.4 % vs. 18.2 %, p = 0.031). For HADS, anxiety significantly improved (5.0 (IQR 2.0-7.0) vs. 3.0 (IQR 1.0-6.5)) (p = 0.037), but not depression (3.0 (IQR 1.0-7.0) vs. 3.0 (IQR 1.0-6.5)) (p = 0.870). FACT-G scores showed no substantial differences. On survey questionnaires, 95.5 % of patients believed the test to be helpful, and 100 % felt "somewhat" or "extremely" confident in the assay as a monitoring tool. While 59.1 % felt that it reduced anxiety, 88.4 % concordantly felt that it did not introduce anxiety. CONCLUSION: ctHPVDNA as a molecular surveillance tool reduced distress levels in HPV(+) OPC patients, with notably high patient confidence in the approach. Further investigation is warranted to judiciously incorporate this emerging modality in surveillance guidelines.

Iron-saturated bovine lactoferrin: a promising chemopreventive agent for hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) is a tumor with minimal chance of cure due to underlying liver diseases, late diagnosis, and inefficient treatments. Thus, HCC treatment warrants the development of additional strategies. Lactoferrin (Lf) is a mammalian multifunctional iron-binding glycoprotein of the innate immune response and can be found as either a native low iron form (native-Lf) or a high iron form (holo-Lf). Bovine Lf (bLf), which shares many functions with human Lf (hLf), is safe for humans and has several anticancer activities, including chemotherapy boost in cancer. We found endogenous hLf is downregulated in HCC tumors compared with normal liver, and decreased hLf levels in HCC tumors are associated with shorter survival of HCC patients. However, the chemoprotective effect of 100% iron saturated holo-bLf on experimental hepatocarcinogenesis has not yet been determined. We aimed to evaluate the chemopreventive effects of holo-bLf in different HCC models. Remarkably, a single dose (200 mg kg-1) of holo-bLf was effective in preventing early carcinogenic events in a diethylnitrosamine induced HCC in vivo model, such as necrosis, ROS production, and the surge of facultative liver stem cells, and eventually, holo-bLf reduced the number of preneoplastic lesions. For an established HCC model, holo-bLf treatment significantly reduced HepG2 tumor burden in xenotransplanted mice. Finally, holo-bLf in combination with sorafenib, the advanced HCC first-line treatment, synergistically decreased HepG2 viability by arresting cells in the G0/G1 phase of the cell cycle. Our findings provide the first evidence suggesting that holo-bLf has the potential to prevent HCC or to be used in combination with treatments for established HCC.

Lesiones cervicales no cariosas: una revisión sistemática / Non carious cervical lesions: a systematic review

Introducción: las lesiones cervicales no cariosas (NCCL, por sus siglas en inglés) son un grupo de lesiones que afectan el área cervical del órgano dental causando hipersensibilidad dentinaria y defectos estéticos. Objetivo: analizar la literatura sobre las lesiones cervicales no cariosas, su etiología, consideraciones anatómicas, características morfológicas de la lesión y tratamientos no restaurativos. Material y métodos: se realizó una búsqueda en la base de datos PubMed, utilizando las palabras clave: non-carious cervical lesions OR noncarious cervical lesions OR tooth wear OR tooth erosion OR dental abfraction OR abfraction, recopilando un total de 78 artículos. Resultados: es necesario determinar la etiología antes de seleccionar las estrategias de tratamiento para las lesiones cervicales no cariosas. Conocer los distintos tipos de tejidos que componen al órgano dentario facilita la comprensión de los factores que participan en el desarrollo de las lesiones cervicales no cariosas. Esto permite que el tratamiento se enfoque más en la causa del problema que en los síntomas. Con esto podemos modificar diversos factores de manera interceptiva, los tratamientos de terapia con láser y compuestos tópicos son una estrategia mínimamente invasiva. Conclusiones: la mejor manera de describir a las lesiones cervicales no cariosas sería como una enfermedad multifactorial. Se debe prestar especial atención en los métodos de diagnóstico, identificando cofactores que propicien el avance de la lesión, como son la fricción y la biocorrosión. Esta revisión brinda datos que asocian a los factores oclusales como una de las principales causas de una enfermedad que afecta a más de la mitad de la población adulta (AU)

Introduction: non-carious cervical lesions (NCCL) are a group of lesions that affect the cervical area of the dental organ causing dentin hypersensitivity and cosmetic defects. Objective: to know, through a systematic review, the current state of non-carious cervical lesions. Material and methods: a search was conducted in the PubMed database, using the keywords: non-carious cervical lesions OR noncarious cervical lesions OR tooth wear OR tooth erosion OR dental abfraction OR abfraction, compiling a total of 78 articles. Results: determining etiology is necessary before selecting treatment strategies for non-carious cervical lesions (NCCL). Know the different types of tissues that make up the dentary organ, facilitate the understanding of the factors involved in the development of noncarious al cervical lesions. This allows treatment to focus more on the cause of the problem than on symptoms. With this we can modify various factors in an interceptive way, laser therapy treatments and topical compounds, are a minimally invasive strategy. Conclusions: the best way to describe non-carious al cervical lesions would be as a multifactorial disease to which special attention should be paid to both diagnostic methods, identifying cofactors that promote the progression of injury, such as friction and biocorrosion. This review provides data that associates occlusal factors as one of the main causes of a disease that affects more than half of the adult population (AU)

Quantification of Intracellular ATP Content in Ex Vivo GC B Cells.

The study of immunometabolism is an important and emerging field in immunology. B-cell activation upon antigen recognition induces profound metabolic changes in the cell, leading to an increase in ATP production to sustain cell proliferation and differentiation. Current methods available to determine the amount of ATP are time-consuming, require extensive sample processing, and need a large amount of starting material. We set up an easy follow-up protocol to determine the relative amount of ATP in living cells, combining cell surface staining with quinacrine. This acridine dye emits a green fluorescent signal in the presence of intracellular ATP. This protocol allows us to determine ATP in small populations of cells using flow cytometry, such as the germinal center.

Implementing Opt-Out HIV Testing in the Alameda County Jails.

Incorporating routine opt-out HIV testing in correctional settings is a critical component of an effective strategy to end the HIV/AIDS epidemic. Between 2012 and 2017, Alameda County jails implemented opt-out HIV testing to identify new cases, link those who were newly diagnosed to care, and reengage those who were previously diagnosed but not in care. Over a 6-year period, 15,906 tests were conducted, with a positivity rate of 0.55% for both newly diagnosed cases and previously diagnosed but out of care. Nearly 80% of those who tested positive were linked to care within 90 days. The high positivity and successful linkage and reengagement with care underscores the need to support HIV testing programs in correctional settings.

Imatinib plasma levels in patients with chronic myeloid leukaemia under routine clinical practice conditions.

INTRODUCTION: The addition of imatinib to the therapeutic arsenal for chronic myeloid leukaemia (CML) has changed the natural course of the disease, in such a way that it is now considered a chronic pathology. However, to achieve therapeutic success, it is necessary to reach adequate plasma concentrations to ensure efficacy and safety.In this study, we aimed to evaluate the plasma concentration of imatinib, analysing its influence on effectiveness and safety in patients with CML. METHODS: We performed a descriptive, multicentre study in which imatinib plasma levels from patients diagnosed with CML between 2019-2020 were analysed. An optimal therapeutic range of 750-1500 ng/mL was established for the stratification of patients, according to their minimum plasma concentrations measured at steady state (Cssmin). RESULTS: A total of 28 patients were included, of whom only 39.3% (n = 11) showed Cssmin within the therapeutic range. 100% of patients with Cssmin >750 ng/mL achieved an optimal molecular response, while only 50% of patients with Cssmin <750 ng/mL achieved an optimal molecular response (p = 0.0004). The toxicity rate was 36.4% for patients with Cssmin >1500 ng/mL and 5.9% for those with Cssmin <1500 ng/mL (p = 0.039). CONCLUSIONS: This study aimed to describe the correlation between the toxicity and effectiveness of imatinib according to its Cssmin in routine clinical practice conditions. Based on our findings, it would be certainly justified to monitor patient plasma concentrations of imatinib on a daily routine basis in our hospitals.

Predictive value of patency capsule and magnetic resonance enterography for capsule endoscopy retention in patients with established Crohn's disease.

INTRODUCTION: retention is the most common adverse event of the small bowel capsule endoscopy procedure. Patency capsule (Medtronic, Dublin, Ireland) and magnetic resonance enterography are two diagnostic methods that can prevent small bowel capsule endoscopy retention. The aim of this study was to evaluate the predictive value of these two diagnostic methods. MATERIAL AND METHODS: a prospective, comparative and observational study was performed in patients with established Crohn's disease. All patients had undergone magnetic resonance enterography and patency capsule procedures. If the patency capsule was not retained, the patient underwent a small bowel capsule endoscopy; otherwise, double balloon enteroscopy was performed to locate the stenosis. Magnetic resonance enterography predictive criteria for retention were analyzed in all cases. Sensitivity, specificity, positive predictive value and negative predictive value of the patency capsule and magnetic resonance enterography compared to small bowel capsule endoscopy or double balloon enteroscopy were calculated. RESULTS: forty patients were included (24 female, 55 ± 13 years old). Retention criteria with capsule endoscopy or double balloon enteroscopy were found in six patients, agreeing in five cases with patency capsule and in three cases with magnetic resonance enterography. Sensitivity, specificity, positive predictive value, negative predictive value and Kappa coefficient for predicting retention with the patency capsule were 83 %, 100 %, 100 % and 97 %, respectively, and 50 %, 91 %, 50 % and 91 %, respectively, with magnetic resonance enterography. CONCLUSIONS: patency capsule has a higher sensitivity and positive predictive value than magnetic resonance enterography for preventing small bowel capsule endoscopy retention in Crohn's disease patients.

Vancomycin versus daptomycin for the treatment of confirmed gram-positive catheter-related bloodstream infections in oncology patients.

OBJECTIVE: To analyse the effectiveness and safety of daptomycin versus vancomycin on the management catheter-related bloodstream  nfections in oncology patients. METHOD: A retrospective study was carried out including all patients admitted  at the Medical Oncology Unit between 2010 and 2018 with positive blood  cultures confirmed catheter-related bloodstream infections due to gram- positive microorganism, who were treated with either vancomycin or  daptomycin. The primary end point was all cause 30-days mortality, 30-days  hospital readmission and length of hospital stay (length of hospital stay). Results: A total of 70 patients with catheter-related bloodstream infections were included in the present study: vancomycin was administered to  61.4% (n = 43) and daptomycin to 38.6% (n = 27) of  patients. 78.5% (n = 55) of isolated bacteria showed a vancomycin minimum  inhibitory concentration ≤ 1 µg/ml. No differences were observed  between the two groups of patients regarding the 30-day mortality rate rate  (32.6% [n = 14] versus 29.6% [n = 8]; p = 0.797), the 30-day re-admission rate (30.2% [n = 13] versus 29.6% [n = 8]; p = 0.957) or the length of  hospital stay (18.9 versus 16.5 days; p = 0.562). Nephrotoxicity rate was  equivalent in both groups: a 7% (n = 3) of vancomycin goup versus a 7.4% (n  = 2) of daptomycin group (p = 0.946). CONCLUSIONS: Our results show that both antibiotics are equivalent in their  safety and effectiveness. Therefore, vancomycin should continue being the  treatment of chose for gram-positive catheter-related bloodstream infections,  in particular at hospital centres with a low prevalence of strains that show  diminished susceptibility to vancomycin.

OBJETIVO: Analizar la eficacia y seguridad de la daptomicina frente a la  vancomicina en el tratamiento de las infecciones del torrente sanguíneo asociadas a catéter vascular en pacientes oncológicos.Método: Se realizó un estudio retrospectivo que incluyó a los pacientes ingresados en la Unidad de Oncología-Médica entre 2010-2018 con infección del torrente sanguíneo asociada a catéter vascular causada por  grampositivos, y que fueron tratados con vancomicina o daptomicina. Como  objetivos principales se determinaron la tasa de mortalidad por todas las  causas a los 30 días, el reingreso hospitalario a los 30 días y la duración de la  estancia hospitalaria. RESULTADOS: El estudio incluyó 70 pacientes con infecciones del torrente sanguíneo asociadas a catéter vascular: el 61,4% (n = 43) recibió  vancomicina y el 38,6% (n = 27) daptomicina. El 78,5% (n = 55) de las  bacterias aisladas presentaron una concentración mínima inhibitoria de  vancomicina ≤ 1 µg/ml. No se observaron diferencias entre ambos grupos de  pacientes en cuanto a la tasa de mortalidad a 30 días (32,6% [n = 14]  frente al 29,6% [n = 8]; p = 0,797), la tasa de reingreso a 30 días (30,2% [n  = 13] frente al 29,6% [n = 8]; p = 0,957) o la duración de la hospitalización (18,9 frente a 16,5 días; p = 0,562). La tasa de nefrotoxicidad fue equivalente  en ambos grupos: 7% (n = 3) para vancomicina frente al 7,4% (n = 2) para  daptomicina (p = 0,946). CONCLUSIONES: Nuestros resultados muestran que ambos antibióticos son equivalentes en su seguridad y eficacia. Por ello, vancomicina debería seguir siendo el tratamiento de elección para la infección del torrente sanguíneo asociada a catéter vascular, especialmente en centros con  una baja prevalencia de cepas con una susceptibilidad disminuida a  ancomicina.

Vulvar Neurodermatitis in a Postmenopausal African-American Patient: A Case Report.

Lichen simplex chronicus commonly presents as a distressing vaginal lesion caused by severe, cyclical itch-scratch behavior. Lichen simplex chronicus is diagnosed by obtaining a detailed medical history, performing a physical exam, and recording of self-reported symptoms. Lichen simplex chronicus can be treated by corticosteroids, immunomodulators, antiepileptics, antihistamines, antidepressants, and phototherapy. Our case describes a 55-year-old female patient who presented to a clinic with recurrent vaginal itching, combined with compulsive scratching behavior that disrupted daily functioning. Physical examination revealed hypertrophic nodules located on the labia minora with scaling and hyperpigmentation. And the patient was diagnosed with lichen simplex chronicus. Empirical treatment with behavioral modifications and clobetasol propionate cream with an occlusive dressing produced significant improvements in symptoms at a six-month follow-up. Lichen simplex chronicus can have unusual presentations and; therefore, must be carefully differentiated from infectious and malignant skin lesions.

Anti-drug antibodies anti-trastuzumab in the treatment of breast cancer.

INTRODUCTION: Trastuzumab is a monoclonal antibody which could induce the activation of a humoral immune response generating anti-drug antibodies (ADAs). Such response depends of the protein nature and the route of administration (intravenous or subcutaneous). The formation of these antibodies could block the action of trastuzumab (ADA-Tras) and forming immune complexes which decrease its efficacy, so it would be interesting to determine the presence of ADA-Tras in patients treated with trastuzumab. MATERIAL AND METHODS: The blood samples were centrifuged to separate the plasma. The presence of ADA-Tras in plasma was determined using an ELISA-type automated immunoassay. RESULTS: Fifty-one women with non-metastatic HER2-positive breast cancer treated with trastuzumab were included. Two groups were studied: patients treated intravenously and subcutaneously. In neither case was there any presence of ADA-Tras. DISCUSSION: This study may be the first ever conducted under usual clinical practice conditions to detect the presence of ADA-Tras in patients with non-metastatic HER2-positive breast cancer. We have wanted to show the antibodies anti-trastuzumab determination as a possible tool that would enable comparison of potential differences in immunogenic behavior between trastuzumab and its biosimilars.

Extended enzymatic stability of reconstituted lyophilized PEG-asparaginase in vials.

Asparaginase (ASNase) use as a tumour-inhibitor drug has changed completely the natural course of paediatric acute lymphoblastic leukaemia (ALL) in such a way that it represents a paradigm shift in ALL management. ASNase treatment emergence has significantly improved pathologic responses and increased survival rates of ALL patients. Although different ASNase forms are currently available, only the pegylated form (PEG-ASNase) is recommended by relevant clinic guides. PEG-ASNase form shows longer elimination half-life, reducing the number of administrations, along with an enhanced safety profile. In spite of all of these advantages, PEG-ASNase elevated cost limits enormously its use. PEG-ASNase is commercialised as a lyophilised powder which according to the manufacturer it is stable for 24 hours once reconstituted, as a result, the leftover is usually discarded. In this study we analysed the enzymatic stability of reconstituted PEG-ASNase after conservation in three different temperature conditions for 5 and 14 days, aiming to take advantage of the remaining leftover for the subsequent administration. Our results have shown that PEG-ASNase is stable at 4°C, -20°C and -80°C for at least 14 days, retaining the 95% from the initial enzymatic activity in all three storage temperatures. According to our results, it is feasible to reuse the remaining content of PEG-ASNase vial after reconstitution, which means a 50% reduction of its cost for paediatric patient treatment and, consequently, removes the main barrier to use this drug in a wider population.

Social Determinants of Discrimination and Access to Health Care Among Transgender Women in Oregon.

Purpose: Transgender women in the United States experience health disparities and limited access to gender-affirming health services. This study describes the social determinants of health that shape access to health services for transgender women in Oregon, a state with a high tally of gender-affirming policies. Methods: We conducted qualitative interviews with 25 transgender women between 18 and 39 years of age. Interviews explored the social, economic, cultural, and legal factors that shape access to health. A Qualtrics survey captured sociodemographic characteristics. We identified facilitators and barriers to accessing gender-affirming services using thematic analysis of qualitative data. Results: Our participants perceived gender-affirming health services in Oregon to be relatively trans-friendly, compared to other parts of the United States. This perception drew several transgender women in our sample to migrate to Oregon from other "more conservative" states. Facilitators included ease with legal name change (60% had completed), inclusiveness of hormone therapy in the Oregon Health Plan, and availability of informed consent hormone therapy. However, for our participants, economic and social discrimination were major limiting factors to accessing and navigating health services. Social factors exacerbated difficulties navigating and understanding health systems to achieve coverage; 20% had insurance that did not cover hormone therapy. Specialized surgeons were located in urban/suburban centers; electrolysis coverage was limited; and 10% had gender-affirming surgery. Conclusion: This study indicates that services are necessary to assist with navigating access to gender-affirming health care, even in affirming policy contexts like Oregon.

Pharmacokinetics of Trastuzumab After Subcutaneous and Intravenous Administration in Obese Patients.

Background: Subcutaneous trastuzumab (T-SC) administration does not allow the historical target concentration of 20 µg/mL for efficacy to be reached, from the start of treatment in patients with a body mass index (BMI) >30 kg/m2. Objectives: To analyze the influence of the strategy of dosification (fixed vs adjusted patient's body weight dose) on the initial minimum plasma concentration (Cmin) of trastuzumab in obese patients. Methods: This was an observational, prospective study, which included patients with HER2-positive nonmetastatic breast cancer treated with trastuzumab. The determination of the Cmin of trastuzumab was performed on day +21 of the first cycle using the ELISA technique. Patients were stratified according to the strategy of dosification and BMI. Results: A total of 50 patients were included; 16 patients received the drug intravenously and 34 in a fixed dosage subcutaneous (T-SC) regimen. The proportion of patients who achieved an adequate plasma concentration since the beginning of treatment was significantly higher when the drug was administered intravenously (93.8% vs 67.6%, P = 0.042). These differences are especially greater in T-SC patients with BMI >30 kg/m2, with only 20% of patients exceeding the pharmacokinetic target. Conclusion and Relevance: Our study suggests that trastuzumab SC fixed dose of 600 mg is not equivalent to IV administration, especially in obese patients. An adequate trastuzumab exposure in this population needs patient weight-adjusted IV dosage in the first administration. The clinical relevance of these findings remains to be elucidated, and further research, including larger controlled trials, is warranted.

Endocuff Vision Reduces Inspection Time Without Decreasing Lesion Detection: A Clinical Randomized Trial.

BACKGROUND & AIMS: Mucosal exposure devices improve detection of lesions during colonoscopy and have reduced examination times in uncontrolled studies. We performed a randomized trial of Endocuff Vision vs standard colonoscopy to compare differences in withdrawal time (the primary end point). We proposed that Endocuff Vision would allow complete mucosal inspection in a shorter time without impairing lesion detection. METHODS: Adults older than 40 years undergoing screening or surveillance colonoscopies were randomly assigned to the Endocuff group (n=101, 43.6% women) or the standard colonoscopy group (n=99; 57.6% women). One of 2 experienced endoscopists performed the colonoscopies, aiming for a thorough evaluation of the proximal sides of all haustral folds, flexures, and valves in the shortest time possible. Inspection time was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. RESULTS: There were significantly fewer women in the Endocuff arm (P = .0475) but there were no other demographic differences between groups. Mean insertion time with Endocuff was 4.0 min vs 4.4 min for standard colonoscopy (P = .14). Mean inspection time with Endocuff was 6.5 min vs 8.4 min for standard colonoscopy (P < .0001). Numbers of adenomas detected per colonoscopy (1.43 vs 1.07; P = .07), adenoma detection rate (61.4% vs 52%; P = .21), number of sessile serrated polyps per colonoscopy (0.27 vs 0.21; P = .12), and sessile serrated polyp detection rate (19.8% vs 11.1%; P = .09) were all higher with Endocuff Vision. Results did not differ significantly when we controlled for age, sex, or race. CONCLUSION: In a randomized trial, we found inclusion of Endocuff in screening or surveillance colonoscopies to decrease examination time without reducing lesion detection. ClinicalTrials.gov, Number: NCT03361917.

Endoscopic management of large ileocecal valve lesions over an 18-year interval.

Background and study aims Ileocecal valve (ICV) lesions are challenging to remove endoscopically. Patients and methods This was a retrospective cohort study, performed at an academic tertiary US hospital. Sessile polyps or flat ICV lesions ≥ 20 mm in size referred for endoscopic mucosal resection (EMR) were included. Successful resection rates, complication rates and recurrence were compared to lesions ≥ 20 mm in size not located on the ICV. Results During an 18-year interval, there were 118 ICV lesions ≥ 20 mm with mean size 28.6 mm (44.9 % females; mean age 71.6 years), comprising 9.03 % of all referred polyps. Ninety ICV lesions (76.3 %) were resected endoscopically, compared to 91.3 % of non-ICV lesions ( P  < 0.001). However, in the most recent 8 years, successful EMR of ICV lesions increased to 93 %. Conventional adenomas comprised 92.2 % of ICV lesions and 7.8 % were serrated. Delayed hemorrhage and perforation occurred in 3.3 % and 0 % of ICV lesions, respectively, compared to 4.8 % and 0.5 % in the non-ICV group. At first follow-up, rates of residual polyp in the ICV and non-ICV groups were 16.5 % and 13.6 %, respectively ( P  = 0.485). At second follow-up residual rates in the ICV and non-ICV lesion groups were 18.6 % and 6.7 %, respectively ( P  = .005). Conclusions Large ICV polyps are a common source of tertiary referrals. Over an 18-year experience, risk of EMR for ICV polyps was numerically lower, and risk of recurrence was numerically higher at first follow and significantly higher at second follow-up compared to non-ICV polyps.

A comparison of 2 distal attachment mucosal exposure devices: a noninferiority randomized controlled trial.

BACKGROUND AND AIMS: Endocuff (Arc Medical Design, Leeds, UK) and Endocuff Vision (Arc Medical Design, Leeds, UK) are effective mucosal exposure devices for improving polyp detection during colonoscopy. AmplifEYE (Medivators Inc, Minneapolis, Minn, USA) is a device that appears similar to the Endocuff devices but has received minimal clinical testing. METHODS: We performed a randomized controlled clinical trial using a noninferiority design to compare Endocuff Vision with AmplifEYE. RESULTS: The primary endpoint of adenomas per colonoscopy was similar in AmplifEYE at 1.63 (standard deviation 2.83) versus 1.51 (2.29) with Endocuff Vision (P = .535). The 95% lower confidence limit was 0.88 for ratio of means, establishing noninferiority of AmplifEYE (P = .008). There was no difference between the arms for mean insertion time, and mean inspection time (withdrawal time minus polypectomy time and time for washing and suctioning) was shorter with AmplifEYE (6.8 minutes vs 6.9 minutes, P = .042). CONCLUSIONS: AmplifEYE is noninferior to Endocuff Vision for adenoma detection. The decision on which device to use can be based on cost. Additional comparisons of AmplifEYE with Endocuff by other investigators are warranted. (Clinical trial registration number: NCT03560128.).

SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial.

BACKGROUND AND AIMS: Viscous solutions provide a superior submucosal cushion for EMR. SIC-8000 (Eleview; Aries Pharmaceuticals, La Jolla, Calif) is a commercially available U.S. Food and Drug Administration-approved solution, but hetastarch is also advocated. We performed a randomized trial comparing SIC-8000 with hetastarch as submucosal injection agents for colorectal EMR. METHODS: This was a single-center, double-blinded, randomized controlled trial performed at a tertiary referral center. Patients were referred to our center with flat or sessile lesions measuring ≥15 mm in size. The primary outcome measures were the Sydney resection quotient (SRQ) and the rate of en bloc resections. Secondary outcomes were total volume needed for a sufficient lift, number of resected pieces, and adverse events. RESULTS: There were 158 patients with 159 adenomas (SIC-8000, 84; hetastarch, 75) and 57 serrated lesions (SIC-8000, 30; hetastarch, 27). SRQ was significantly better in the SIC-8000 group compared with hetastarch group (9.3 vs 8.1, P = .001). There was no difference in the proportion of lesions with en bloc resections. The total volume of injectate was significantly lower with SIC-8000 (14.8 mL vs 20.6 mL, P = .038). CONCLUSIONS: SIC-8000 is superior to hetastarch for use during EMR in terms of SRQ and total volume needed, although the absolute differences were small. (Clinical trial registration number: NCT03350217.).