AGA Clinical Practice Guideline on Endoscopic Eradication Therapy of Barrett's Esophagus and Related Neoplasia.

BACKGROUND & AIMS: Barrett's esophagus (BE) is the precursor to esophageal adenocarcinoma (EAC). Endoscopic eradication therapy (EET) can be effective in eradicating BE and related neoplasia and has greater risk of harms and resource use than surveillance endoscopy. This clinical practice guideline aims to inform clinicians and patients by providing evidence-based practice recommendations for the use of EET in BE and related neoplasia. METHODS: The Grading of Recommendations Assessment, Development and Evaluation framework was used to assess evidence and make recommendations. The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients, conducted an evidence review, and used the Evidence-to-Decision Framework to develop recommendations regarding the use of EET in patients with BE under the following scenarios: presence of (1) high-grade dysplasia, (2) low-grade dysplasia, (3) no dysplasia, and (4) choice of stepwise endoscopic mucosal resection (EMR) or focal EMR plus ablation, and (5) endoscopic submucosal dissection vs EMR. Clinical recommendations were based on the balance between desirable and undesirable effects, patient values, costs, and health equity considerations. RESULTS: The panel agreed on 5 recommendations for the use of EET in BE and related neoplasia. Based on the available evidence, the panel made a strong recommendation in favor of EET in patients with BE high-grade dysplasia and conditional recommendation against EET in BE without dysplasia. The panel made a conditional recommendation in favor of EET in BE low-grade dysplasia; patients with BE low-grade dysplasia who place a higher value on the potential harms and lower value on the benefits (which are uncertain) regarding reduction of esophageal cancer mortality could reasonably select surveillance endoscopy. In patients with visible lesions, a conditional recommendation was made in favor of focal EMR plus ablation over stepwise EMR. In patients with visible neoplastic lesions undergoing resection, the use of either endoscopic mucosal resection or endoscopic submucosal dissection was suggested based on lesion characteristics. CONCLUSIONS: This document provides a comprehensive outline of the indications for EET in the management of BE and related neoplasia. Guidance is also provided regarding the considerations surrounding implementation of EET. Providers should engage in shared decision making based on patient preferences. Limitations and gaps in the evidence are highlighted to guide future research opportunities.

Chinese expert consensus of image-guided irreversible electroporation for pancreatic cancer.

Pancreatic cancer (PC) is a lethal disease with extremely high mortality. Although surgical resection is the optimal therapeutic approach for PC, about 30%-40% of those patients are not candidates for surgical resection when diagnosed. Chemotherapy and radiotherapy also could not claim a desirable effect on PC. The application of interventional radiology approaches is limited by unavoidable damage to the surrounding vessels or organs. By the superiority of mechanism and technology, IRE could ablate the tumor by creating irreversible pores on the membrane of PC cells with other tissues like vessels and pancreatic ducts untouched. This consensus gathers the theoretical basis and clinical experience from multiple Chinese medical centers, to provide the application principles and experience from Chinese experts in the IRE field.

Asian Conference on Tumor Ablation guidelines for renal cell carcinoma.

Thermal ablation has been established as an alternative treatment for renal cell carcinoma (RCC) in patients who are poor candidates for surgery. However, while American and European guidelines have been established for American and European patients, respectively, no ablation guidelines for Asian patients with RCCs have been established many years after the Asian Conference on Tumor Ablation (ACTA) had been held. Given that Western guidelines are difficult to apply to Asian patients due to differences in body habitus, economic status, and insurance systems, the current review sought to establish the first version of the ACTA guidelines for treating a RCC with thermal ablation.

Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART II.

PURPOSE: The summary presented herein represents Part II of the two-part series dedicated to Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline discussing prognostic and treatment recommendations for patients with castration-resistant disease. Please refer to Part I for discussion of the management of patients with biochemical recurrence without metastatic disease after exhaustion of local treatment options as well as those with metastatic hormone-sensitive prostate cancer. RESULTS: The Advanced Prostate Cancer Panel created evidence- and consensus-based guideline statements to aid clinicians in the management of patients with advanced prostate cancer. Such statements are summarized in figure 1[Figure: see text] and detailed herein. MATERIALS AND METHODS: The systematic review utilized to inform this guideline was conducted by an independent methodological consultant. A research librarian conducted searches in Ovid MEDLINE (1998 to January Week 5 2019), Cochrane Central Register of Controlled Trials (through December 2018), and Cochrane Database of Systematic Reviews (2005 through February 6, 2019). An updated search was conducted prior to publication through January 20, 2020. The methodology team supplemented searches of electronic databases with the studies included in the prior AUA review and by reviewing reference lists of relevant articles. CONCLUSIONS: This guideline attempts to improve a clinician's ability to treat patients diagnosed with advanced prostate cancer. Continued research and publication of high-quality evidence from future trials will be essential to improve the level of care for these patients.

Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline PART I.

PURPOSE: The summary presented herein represents Part I of the two-part series dedicated to Advanced Prostate Cancer: AUA/ASTRO/SUO Guideline discussing prognostic and treatment recommendations for patients with biochemical recurrence without metastatic disease after exhaustion of local treatment options as well as those with metastatic hormone-sensitive prostate cancer. Please refer to Part II for discussion of the management of castration-resistant disease. MATERIALS AND METHODS: The systematic review utilized to inform this guideline was conducted by an independent methodological consultant. A research librarian conducted searches in Ovid MEDLINE (1998 to January Week 5 2019), Cochrane Central Register of Controlled Trials (through December 2018), and Cochrane Database of Systematic Reviews (2005 through February 6, 2019). An updated search was conducted prior to publication through January 20, 2020. The methodology team supplemented searches of electronic databases with the studies included in the prior AUA review and by reviewing reference lists of relevant articles. RESULTS: The Advanced Prostate Cancer Panel created evidence- and consensus-based guideline statements to aid clinicians in the management of patients with advanced prostate cancer. Such statements are summarized in figure 1[Figure: see text] and detailed herein. CONCLUSIONS: This guideline attempts to improve a clinician's ability to treat patients diagnosed with advanced prostate cancer. Continued research and publication of high-quality evidence from future trials will be essential to improve the level of care for these patients.

Management and treatment outcomes of patients undergoing endovenous ablation are significantly different between Intersocietal Accreditation Commission-accredited and nonaccredited vein centers.

OBJECTIVE: The Intersocietal Accreditation Commission of vein centers was instituted in 2014, yet data regarding impact of accreditation on patients undergoing superficial vein interventions are lacking. This study was undertaken to identify differences in patient outcomes and utilization index as a measure of appropriate use in accredited compared with nonaccredited centers. METHODS: This study was performed with a matched control design using prospectively collected data from two major U.S.-based venous registries: the Society for Vascular Surgery Vascular Quality Initiative Varicose Vein Registry and the American Vein & Lymphatic Society PRO Venous Registry. RESULTS: A total of 39,001 patients treated between 2015 and 2018 in 192 centers were included in the study. The Vascular Quality Initiative Varicose Vein Registry provided information on 19,810 (50.8%) patients, and the American Vein & Lymphatic Society PRO Venous Registry provided information on 19,191 (49.2%) patients. Accredited centers were significantly more likely to treat patients with advanced venous disease as characterized by trophic skin changes (C4-C6, 38.1% vs 25.2%; P < .001). Percentage of patients treated 2 standard deviations above the Medicare-reported mean (3.4 utilization index) was significantly higher among patients treated at nonaccredited centers (3.3% vs 0.1%; P < .001). Venous Clinical Severity Score of those who were assessed between 1 month and 1 year after ablation decreased by 4.98 ± 4.01 in nonaccredited centers compared with 5.61 ± 3.64 in accredited centers (P < .001). Complications were low in both cohorts (nonaccredited centers, 71 [0.4%]; accredited centers, 17 [0.1%]; P < .001). One-year clinical follow-up was higher in nonaccredited centers (76.4% vs 31.5%; P < .001). CONCLUSIONS: Venous registries are a powerful tool for capturing and identifying significant variations in procedure utilization and complications in low-risk procedures. Intersocietal Accreditation Commission accreditation was associated with reduced use of endovenous therapies, slightly lower complication rates, lower 1-year follow up, and greater improvement in Venous Clinical Severity Score.

The recommended goal in the United Kingdom's National Institute for Health and Care Excellence Clinical Guideline 168 for immediate referral of patients with bleeding varicose veins is not being achieved.

OBJECTIVE: Published in July 2013, National Institute for Health and Care Excellence Clinical Guideline 168 (CG168) recommended that people with bleeding varicose veins be referred immediately to a vascular service. We have examined the impact of CG168 on referral practice for patients with bleeding varicose veins from primary to secondary care in a local National Health Service setting. METHODS: Referrals to a local vascular service in the 6 years before (group 1) and 6 years after (group 2) publication of CG168 were analyzed to assess patients' management after a bleed, with particular reference to a patient's initial presentation and delays in referral to the vascular service. This was done by retrospective electronic database and case note interrogation of patients presenting with bleeding varicose veins. Relevant data were collected onto an Excel spread sheet (Microsoft, Redmond, Wash) in relation to demographic information, comorbidities, clinical presentation, and treatment pathway. RESULTS: During the period studied, 73 patients presented with bleeding varicose veins. Their mean age was 66 years, and 56% were men. Their mean body mass index was 28 kg/m2. Of note, 33 patients (45%) initially self-treated before going to see their general practitioner; another 18 (25%) went to the emergency department. In 51 patients (70%), the underlying superficial disease involved the great saphenous vein, and most patients (73%) were treated with foam sclerotherapy with or without truncal thermal ablation; 45 patients (group 1) were treated in the 6 years before publication of CG168, and 28 patients, allowing 6 months for dissemination, were treated in the 6 years after CG168 publication (group 2). Mean time from index bleed to referral to the vascular service was faster after publication of CG168 (84 days before and 20 days after publication of CG168; P = .00842). Publication of CG168 was also associated with reduced mean bleed to intervention times (194 vs 60 days; P = .00097). CONCLUSIONS: Publication of UK National Institute for Health and Care Excellence guideline CG168 has been associated with a significant reduction in the delay to referral of patients presenting with bleeding varicose veins; however, the goal of immediate referral to a vascular service is not being met. CG168 is likely to have been a significant component of the factors that have led to the improvements seen thus far.

Irreversible Electroporation for Hepatic Tumors: Protocol Standardization Using the Modified Delphi Technique.

PURPOSE: A consensus study of panelists was performed to provide a uniform protocol regarding (contra) indications, procedural parameters, perioperative care, and follow-up of irreversible electroporation (IRE) for the treatment of hepatic malignancies. MATERIALS AND METHODS: Interventional radiologists who had 2 or more publications on IRE, reporting at least 1 patient cohort in the field of hepatobiliary IRE, were recruited. The 8 panelists were asked to anonymously complete 3 iterative rounds of IRE-focused questionnaires to collect data according to a modified Delphi technique. Consensus was defined as having reached 80% or greater agreement. RESULTS: Panel members' response rates were 88%, 75%, and 88% in rounds 1, 2, and 3, respectively; consensus was reached on 124 of 136 items (91%). Percutaneous or intraoperative hepatic IRE should be considered for unresectable primary and secondary malignancies that are truly unsuitable for thermal ablation because of proximity to critical structures. Absolute contraindications are ventricular arrhythmias, cardiac stimulation devices, and congestive heart failure of New York Heart Association class 3 or higher. A metal stent outside the ablation zone should not be considered a contraindication. For the only commercially available IRE device, the recommended settings are an inter-electrode distance of 10-20 mm and an exposure length of 20 mm. After 10 test pulses, 90 treatment pulses of 1500 V/cm should be delivered continuously, with a pulse length of 70-90 µs. The first post-procedural follow-up should take place 1 month after IRE and thereafter every 3 months, using cross-sectional imaging plus tumor marker assessment. CONCLUSIONS: This article provides recommendations, created by a modified Delphi consensus study, regarding patient selection, workup, procedure, and follow-up of IRE treatment for hepatic malignancies.

Management of Recurrent HCC After Liver Transplantation.

BACKGROUND: Liver transplantation is the best treatment option for hepatocellular carcinoma (HCC). Although centers use strict selection criteria, there is a risk of recurrence, reaching up to 20% which are mostly observed within two years following the procedure. The survival after the recurrence is poor and it has been reported to be between 7-16 months. This poor prognosis is due to the systemic course of the recurrence even its presentation is local initially. RESULTS: The clinical management and treatment algorithm of recurrence is challenging and there is no guideline regarding the situation. Staging of the disease and multi-disciplinary approach are important. The decision for choice of treatment is given depending on the localization and spread of the recurrence. Adjusting and switching the immunosuppressive therapy should be the first attempt. When the recurrence is limited or confined to resectable regions, surgery should be the choice of treatment. Multiple recurrence sites such as adrenal glands, lung, lymph nodes are not contraindication for curative surgery. Resection of the graft for intrahepatic recurrence is the most beneficial procedure for survival. If resection is not possible due to advanced hepatic disease, loco-regional therapies such as TACE, RF, microwave ablation should be considered. SBRT may be an alternative both for hepatic and extra-hepatic recurrence. In case of systemic disease, sorafenib should be the drug choice.

What Should Be the Rules for Downstaging for Hepatocellular Carcinoma?

INTRODUCTION: Liver transplantation remains the main curative treatment method for hepatocellular carcinoma. There are several criteria for hepatocellular carcinoma to be eligible for liver transplantation, and it depends on main transplantation centers worldwide. Locoregional treatments and downstaging protocols are used for either to achieve these criteria or to prevent drop outs on the transplant waiting lists. But who can benefit from these bridging therapies effectively for the main purpose of curative treatment? Main contraindications are known for locoregional treatments like cirrhosis or low hepatic function, total main portal vein occlusion, and extrahepatic metastasis. HCCs, which are confined to liver but have high tumor burden, remains the main controversial issue. AIM: On this aspect, we reviewed the literature for downstaging protocols for hepatocellular carcinoma with their effect on survival and recurrence rates after liver transplantation. CONCLUSION: Although candidates for downstaging is still controversial, with the absence of main contraindications, LRT can be applied to selected HCCs, which have a certain degree of tumor burden.

Tumor Diameter for Hepatocellular Carcinoma: Why Should Size Matter?

PURPOSE: There are two main goals in hepatocellular carcinoma management, the first is long term survival and the second is the low recurrence rate after the treatment. Therefore, a lot of selection criteria defined for each treatment method and tumor size is one of the most important parameter in almost all of them. METHODS: In this review, importance of diamater in hepatocellular carcinoma is reviewed. RESULTS: Many reports showed a significant association between increase in maximum tumor diameter and microvascular invasion. Patients with larger tumors are more likely to have poorly differentiated tumors. Increased regional and distant metastasis of tumors were observed in the larger size hepatocellular carcinoma. Liver transplantation represents the best treatment option for patients with decompensated liver cirrhosis and hepatocellular carcinoma. CONCLUSIONS: Combined with biological, inflammatory, radiological, pathological and genetic markers that predict the biological behavior of the tumor, today, tumor size is one of the best aggressiveness markers until new markers are found. So, tumor size is matter.

Immunomodulatory effects of ablation therapy on tumors: Potentials for combination with immunotherapy.

As a promising area of tumor treatment, immunotherapies, such as immune checkpoint inhibitors, have been applied to various types of cancer. However, many patients do not respond to such therapies. Increasing application of tumor ablation therapy, a minimally invasive treatment, has been observed in the clinic. Although it can boost the anti-tumor immune response of patients in many ways, ablation alone is not sufficient to remove the tumor completely or stop tumor recurrence in the long term. Currently, there is emerging research focusing on ablation in combination with immunotherapy, aiming to confirm the therapeutic value of this treatment for cancer patients. Hence, in this article, we review the classification, guideline recommendations, and immunomodulatory effects of ablation therapy, as well as the pre-clinical and clinical research of this combination therapy.

Posttransplant Management of Recipients Undergoing Liver Transplantation for Hepatocellular Carcinoma. Working Group Report From the ILTS Transplant Oncology Consensus Conference.

Although liver transplantation (LT) is the best treatment for patients with localized hepatocellular carcinoma (HCC), recurrence occurs in 6%-18% of patients. Several factors, particularly morphological criteria combined with dynamic parameters, known before LT modify this risk and combined in prediction models may be used to stratify patients at need of variable surveillance strategies. Additional variables though likely explain differences in recurrence rates in patients with the same pre-LT HCC status. One of these variables is possibly immunosuppression (IS). Once recurrence takes place, management is highly heterogenous. Within the International Liver Transplantation Society Consensus Conference on Liver Transplant Oncology, working group 4 aim was to analyze the data regarding posttransplant management of recipients undergoing LT for HCC. Three areas of research were considered: (1) cancer prediction models and surveillance strategies; (2) tailored IS for cancer recipients; and (3) new adjuvant therapies for HCC recurrence. Following formulation of several questions, a literature search was undertaken with abstract review followed by article retrieval and full-data extraction. The grading of recommendations assessment, development and evaluation (GRADE) system was used for evidence rating incorporating strength of recommendation and quality of evidence.

Credentialing of vertebral stereotactic ablative body radiotherapy in a multi-centre trial.

PURPOSE/OBJECTIVE: Stereotactic ablative body radiotherapy (SABR) in multi-centre trials requires rigorous quality assurance to ensure safe and consistent treatment for all trial participants. We report results of vertebral SABR dosimetry credentialing for the ALTG/TROG NIVORAD trial. MATERIAL/METHODS: Centres with a previous SABR site visit performed axial film measurement of the benchmarking vertebral plan in a local phantom and submitted radiochromic film images for analysis. Remaining centres had on-site review of SABR processes and axial film measurement of the vertebral benchmarking plan. Films were analysed for dosimetric and positional accuracy: gamma analysis (>90% passing 2%/2mm/10% threshold) and ≤ 1 mm positional accuracy at target-cord interface was required. RESULTS: 19 centres were credentialed; 11 had on-site measurement. Delivery devices included linear accelerator, TomoTherapy and CyberKnife systems. Five centres did not achieve 90% gamma passing rate. Of these, three were out of tolerance (OOT) in low (<5Gy) dose regions and > 80% passing rate and deemed acceptable. Two were OOT over the full dose range: one elected not to remeasure; the other also had positional discrepancy greater than 1 mm and repeat measurement with a new plan was in tolerance. The original OOT was attributed to inappropriate MLC constraints. All centres delivered planned target-cord dose gradient within 1 mm. CONCLUSION: Credentialing measurements for vertebral SABR in a multi-centre trial showed although the majority of centres delivered accurate vertebral SABR, there is high value in independent audit measurements. One centre with inappropriate MLC settings was detected, which may have resulted in delivery of clinically unacceptable vertebral SABR plans.

Radiation in the Treatment of Oligometastatic and Oligoprogressive Disease: Rationale, Recent Data, and Research Questions.

The use of local ablative therapy or metastasis-directed therapy is an emerging management paradigm in oligometastatic and oligoprogressive cancer. Recent randomized evidence has demonstrated that stereotactic ablative radiotherapy (SABR) targeting all metastatic deposits is tolerable and can improve progression-free and overall survival. While SABR is noninvasive, minimally toxic, and generally safe, rare grade 5 events have been reported. Given this and recognizing the often-uncertain prognosis of patients with metastatic disease, equipoise persists regarding the therapeutic window within which to deploy SABR for this indication. Ongoing phase III trials are aimed at validating the demonstrated safety, tolerability, and survival benefits while also refining patient selection, possibly with the aid of novel biomarkers. This narrative review of the role of SABR in oligometastatic and oligoprogressive disease summarizes recent randomized evidence and ongoing clinical trials, discusses our rationale for treatment and key management principles, and posits that SABR should be considered the preferred modality for multisite, metastasis-directed ablative therapy.

Radiotherapy in the Management of Metastatic Hormone-Sensitive Prostate Cancer: What Is the Standard of Care?

Systemic therapy has historically been the backbone of treatment for patients with metastatic disease. However, recent evidence suggests metastasis-directed therapy in those with oligometastatic disease (≤5 lesions) may improve progression-free and overall survival. Within prostate cancer-specific cohorts, metastasis-directed therapy also appears to delay the time to initiation of androgen deprivation therapy while also generally being associated with a mild toxicity profile and has thus garnered interest as a means to delay systemic therapy. Here we review the evidence surrounding the use of radiation therapy to metastatic sites in patients with metastatic hormone-sensitive prostate cancer.

Using Aquablation to Treat Lower Urinary Tract Symptoms in Benign Prostatic Hyperplasia.

Editor's note: This is a summary of a nursing care-related systematic review from the Cochrane Library. For more information, see https://nursing.cochrane.org.

Guideline-Based Referral for Septal Reduction Therapy in Obstructive Hypertrophic Cardiomyopathy Is Associated With Excellent Clinical Outcomes.

BACKGROUND: The outcome of medically refractory patients with obstructive hypertrophic cardiomyopathy treated according to the American College of Cardiology/American Heart Association consensus guideline recommendations is not known. The objectives of this study were to define the short- and long-term outcomes of medically refractory obstructive hypertrophic cardiomyopathy patients undergoing alcohol septal ablation (ASA) and surgical septal myectomy (SM) with patient management in accordance with these consensus guidelines, as well as to quantify procedural risk and burden of comorbid conditions at the time of treatment. METHODS AND RESULTS: Patients with obstructive hypertrophic cardiomyopathy referred for either ASA or SM from 2004 to 2015 were followed for the primary end point of short- and long-term mortality and compared with respective age- and sex-matched US populations. Of 477 consecutive severely symptomatic patients, 99 underwent ASA and 378 SM. Compared with SM, ASA patients were older ( P<0.001), had a higher burden of comorbid conditions ( P<0.01), and significantly higher predicted surgical mortality ( P<0.005). Procedure-related mortality was 0.3% and similarly low in both groups (0% in ASA and 0.8% in SM). Over 4.0±2.9 years of follow-up, 95% of patients had substantial improvement in heart failure symptoms to New York Heart Association class I/II (96% in SM and 90% in ASA). Long-term mortality was similar between the 2 groups with no difference compared with age- and sex-matched US populations. CONCLUSIONS: Guideline-based referral for ASA and SM leads to excellent outcomes with low procedural mortality, excellent long-term survival, and improvement in symptoms. These outcomes occur in ASA patients despite being an older cohort with significantly more comorbidities.