Multiple Bowen's disease due to long-term narrow-band ultraviolet B phototherapy: A case report and literature review.

OBJECTIVE: By presenting a case study on multiple instances of Bowen's disease and the consistent use of narrow-band ultraviolet B (NB-UVB) phototherapy over a three-year period, our aim is to enhance the comprehension of domestic clinicians regarding the disease. Additionally, we seek to review existing literature, encouraging dermatologists to consider clinical secondary primary lesion diagnoses. METHOD: Our approach involves analyzing a diagnosed case of multiple Bowen's disease, examining clinical manifestations, histopathology, imaging results, and treatment methods related to NB-UVB phototherapy. We aim to facilitate discussion and understanding through a comprehensive literature analysis. RESULTS: An elderly male with a 30-year history of psoriasis vulgaris initiated continuous NB-UVB therapy three years ago. A year later, he developed red patches and plaques with distinct borders and scaly surfaces on his face, trunk, lower extremities, and scrotum. Histopathological examination confirmed Bowen's disease. Treatment involved liquid nitrogen cryotherapy, with no recurrence observed during the one-year follow-up. CONCLUSION: This case highlights that Bowen's disease, typically solitary, can manifest as multiple instances, especially in individuals with a history of psoriasis vulgaris. While NB-UVB stands as the primary treatment for psoriasis vulgaris, caution is warranted due to the potential risk of skin tumor induction with prolonged high-dose usage. Clinicians should be vigilant in monitoring and assessing the long-term implications of such therapies.

Spray Cryotherapy for Benign Large Airway Stenosis: A Multicenter Retrospective Cohort Study of Safety and Practice Patterns.

BACKGROUND: Benign airway stenosis (BAS) represents a significant burden on patients, providers, and healthcare systems. Spray cryotherapy (SCT) has been proposed as an adjunctive treatment to reduce BAS recurrence. We sought to examine safety and practice variations of the latest SCT system when used for BAS. METHODS: We conducted a retrospective multicenter cohort study in seven academic institutions within the Interventional Pulmonary Outcomes Group. All patients who underwent at least one SCT session with a diagnosis of BAS at the time of procedure at these institutions were included. Demographics, procedure characteristics, and adverse events were captured through each center's procedural database and electronic health record. RESULTS: A total of 102 patients underwent 165 procedures involving SCT from 2013 to 2022. The most frequent etiology of BAS was iatrogenic (n = 36, 35%). In most cases, SCT was used prior to other standard BAS interventions (n = 125; 75%). The most frequent SCT actuation time per cycle was five seconds. Pneumothorax complicated four procedures, requiring tube thoracostomy in two. Significant post-SCT hypoxemia was noted in one case, with recovery by case conclusion and no long-term effects. There were no instances of air embolism, hemodynamic compromise, or procedural or in-hospital mortality. CONCLUSION: SCT as an adjunctive treatment for BAS was associated with a low rate of complications in this retrospective multicenter cohort study. SCT-related procedural aspects varied widely in examined cases, including actuation duration, number of actuations, and timing of actuations relative to other interventions.

Efficacy and Safety of Precision Cryotherapy to Treat Seborrheic Dermatitis of the Scalp.

BACKGROUND: Recently, a new cryotherapy device that precisely controls skin temperature was developed. Precision cryotherapy (PC) can be a safe and alternative treatment modality for immune-related skin diseases that are difficult to treat by conventional cryotherapy because of serious adverse events. OBJECTIVE: To evaluate the efficacy and safety of PC in scalp seborrheic dermatitis (SD). METHODS: A single-arm, prospective trial was designed. Twenty-four patients with SD underwent 3 PC interventions 2 weeks apart. At the baseline, Week 6, and Week 8, overall improvements in Physician Global Assessment (PGA) and clinical severity scores were assessed. At each visit, the erythema index (EI) and transepidermal water loss were evaluated. The patients scored 9 subjective symptoms using a visual analog scale (VAS). RESULTS: The itch VAS score decreased by 50.4% at Week 8. Blinded investigators reported improvement of PGA scores from 2.86 ± 0.62 to 1.66 ± 0.61 and clinical severity scores from 4.55 ± 1.30 to 2.45 ± 1.37. The average EI decreased by 19.6% at Week 8 ( p < .05). CONCLUSION: This study not only demonstrated the efficacy and safety of PC in scalp SD but it also revealed insights for PC being a promising treatment modality in immune-related skin diseases.

Cryolipolysis in the United States-Review of the clinical data.

BACKGROUND: Noninvasive body contouring is becoming more popular in the United States as an alternative to liposuction. The most popular of these methods, cryolipolysis, uses precisely controlled cooling to reduce focal adiposities. The number of cryolipolysis procedures performed annually has experienced rampant growth in United States markets, and the indications have likewise diversified. In light of this change, it is imperative to perform an updated review of available US safety and efficacy data on cryolipolysis. AIMS: To examine the safety and efficacy of cryolipolysis treatments in the United States using data extracted from research performed exclusively at US-based sites. METHODS: In order to identify relevant studies, a literature search was conducted on PubMed using the terms "CoolSculpting" OR "cryolipolysis" OR "lipocryolysis." Articles were manually reviewed to exclude literature reviews, research not performed on humans, studies on experimental combinations of techniques, and any studies not performed in the United States. RESULTS: The initial literature search returned 246 results. Following manual review, a total of 18 studies were selected for data extraction. Mean reduction in fat thickness by ultrasound was 2.0-5.1 mm or 19.6%-32.3%; mean reduction by body caliper was 2.3-7 mm or 14.9%-21.5%. Side effects were mild and transient. Four instances of PAH were documented in 3453 treatment cycles. CONCLUSIONS: Cryolipolysis is a safe, modestly effective method for reducing focal adiposity. Complications are rare and treatable. However, US-based studies are few in number and often of low power and/or quality. More high-quality research is needed for all aspects of cryolipolysis.

Cryolipolysis: A promising nonsurgical technique for localized fat reduction.

BACKGROUND: Cryolipolysis, also known as fat freezing, is a nonsurgical technique specialized for localized fat reduction. Utilizing targeted cold exposure to adipose tissue, cryolipolysis devices induce cellular apoptosis in adipocytes while sparing surrounding tissues, resulting in the selective disruption of fat cells and subsequent removal of damaged cells by macrophages. A reduction of the fat layer produces a noninvasive cosmetic benefit that provides an accessible alternative to liposuction. Objective and subjective measurements have demonstrated significant reduction in fat volume and high patient satisfaction rates. Cryolipolysis has been proven to be safe with minimal adverse effects. However, further research is needed to fully understand the mechanism of cryolipolysis and its efficacy in different treatment areas. This paper aims to provide a comprehensive overview of cryolipolysis, including its mechanism of action, indications, contraindications, adverse effects, results and outcomes, safety profile, and areas requiring further research. METHODS: Our primary phase of literature review consisted of a PubMed search looking for all published literature around cryolipolysis. We employed a review approach that examined over 30 papers with the key search terms of "cryolipolysis," "fat-freezing," "cosmetic dermatology," "body contouring," "adverse effects," "adipocyte apoptosis," "Coolsculpting®," "cold panniculitis," and "localized fat reduction." We then analyzed each paper, extracting relevant information to gain a multidimensional understanding of cryolipolysis to provide a comprehensive review. CONCLUSION: Cryolipolysis, with its ability to target and reduce localized adipose tissue, has emerged as a promising nonsurgical technique in the field of body contouring. It offers patients a valuable option for achieving their desired fat reduction without the need for a lengthy recovery period or major surgery. Cryolipolysis has shown to reduce the number of adipocytes in the treated area, a phenomenon that can be objectively quantified through various means, including fat caliper measurements, ultrasound assessments, and 3D imaging, or subjectively observed through patient satisfaction rates, clinical observations, and investigator assessments. In addition to its effectiveness in reducing localized adipose tissue, cryolipolysis also holds potential in the area of skin tightening. Preliminary studies suggest that cryolipolysis may have a positive impact on skin elasticity and tightening. Further investigation of this mechanism is needed to provide a better understanding of its potential in achieving optimal cosmetic outcomes for patients. By combining the benefits of fat reduction and skin tightening, cryolipolysis has the potential to offer a comprehensive nonsurgical solution for body contouring.

Evaluating safety risks of whole-body cryotherapy/cryostimulation (WBC): a scoping review from an international consortium.

Over the two last decades, whole-body cryotherapy/cryostimulation (WBC) has emerged as an exciting non-pharmacological treatment influencing inflammatory events at a cellular and physiological level, which can result in improved sleep quality, faster neuromuscular recovery after high-intensity exercise, and chronic pain relief for patients suffering different types of diseases (fibromyalgia, rheumatism, arthritis). Some evidence even suggests that WBC has benefits on mental health (depression, anxiety disorders) and cognitive functions in both adults and older adults, due to increased circulating BDNF levels. Recently, some safety concerns have been expressed by influential public health authorities (e.g., FDA, INSERM) based on reports from patients who developed adverse events upon or following WBC treatment. However, part of the data used to support these claims involved individuals whose entire body (except head) was exposed to extreme cold vaporized liquid nitrogen while standing in a narrow bathtub. Such a procedure is known as partial-body cryotherapy (PBC), and is often erroneously mistaken to be whole-body cryotherapy. Although having similarities in terms of naming and pursued aims, these two approaches are fundamentally different. The present article reviews the available literature on the main safety concerns associated with the use of true whole-body cryotherapy. English- and French-language reports of empirical studies including case reports, case series, and randomized controlled trials (RCTs) were identified through searches of PubMed, Scopus, Cochrane, and Web of Science electronic databases. Five case reports and two RCTs were included for a total of 16 documented adverse events (AEs). A critical in-depth evaluation of these AEs (type, severity, context of onset, participant's medical background, follow-up) is proposed and used to illustrate that WBC-related safety risks are within acceptable limits and can be proactively prevented by adhering to existing recommendations, contraindications, and commonsense guidelines.

Cryotherapy following total knee replacement.

BACKGROUND: Total knee replacement (TKR) is a common intervention for people with end-stage symptomatic knee osteoarthritis, resulting in significant improvements in pain, function and quality of life within three to six months. It is, however, acutely associated with pain, local oedema and blood loss. Post-operative management may include cryotherapy. This is the application of low temperatures to the skin surrounding the surgical site, through ice or cooled water, often delivered using specialised devices. This is an update of a review published in 2012. OBJECTIVES: To evaluate the effect of cryotherapy in the acute phase after TKR (within 48 hours after surgery) on blood loss, pain, transfusion rate, range of motion, knee function, adverse events and withdrawals due to adverse events. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, six other databases and two trials registers, as well as reference lists, related links and conference proceedings on 27 May 2022. SELECTION CRITERIA: We included randomised controlled trials or controlled clinical trials comparing cryotherapy with or without other treatments (such as compression, regional nerve block or continuous passive motion) to no treatment, or the other treatment alone, following TKR for osteoarthritis. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, extracted data and assessed risk of bias and certainty of evidence using GRADE. We discussed any disagreements and consulted another review author to resolve them, if required. Major outcomes were blood loss, pain, transfusion rate, knee range of motion, knee function, total adverse events and withdrawals from adverse events. Minor outcomes were analgesia use, knee swelling, length of stay, quality of life, activity level and participant-reported global assessment of success. MAIN RESULTS: We included 22 trials (20 randomised trials and two controlled clinical trials), with 1839 total participants. The mean ages reflected the TKR population, ranging from 64 to 74 years. Cryotherapy with compression was compared to no treatment in four studies, and to compression alone in nine studies. Cryotherapy without compression was compared to no treatment in eight studies. One study compared cryotherapy without compression to control with compression alone. We combined all control interventions in the primary analysis. Certainty of evidence was low for blood loss (downgraded for bias and inconsistency), pain (downgraded twice for bias) and range of motion (downgraded for bias and indirectness). It was very low for transfusion rate (downgraded for bias, inconsistency and imprecision), function (downgraded twice for bias and once for inconsistency), total adverse events (downgraded for bias, indirectness and imprecision) and withdrawals from adverse events (downgraded for bias, indirectness and imprecision). The nature of cryotherapy made blinding difficult and most studies had a high risk of performance and detection bias. Low-certainty evidence from 12 trials (956 participants) shows that cryotherapy may reduce blood loss at one to 13 days after surgery. Blood loss was 825 mL with no cryotherapy and 561 mL with cryotherapy: mean difference (MD) 264 mL less (95% confidence interval (CI) 7 mL less to 516 mL less). Low-certainty evidence from six trials (530 participants) shows that cryotherapy may slightly improve pain at 48 hours on a 0- to 10-point visual analogue scale (lower scores indicate less pain). Pain was 4.8 points with no cryotherapy and 3.16 points with cryotherapy: MD 1.6 points lower (95% CI 2.3 lower to 1.0 lower). We are uncertain whether cryotherapy improves transfusion rate at zero to 13 days after surgery. The transfusion rate was 37% with no cryotherapy and 79% with cryotherapy (risk ratio (RR) 2.13, 95% CI 0.04 to 109.63; 2 trials, 91 participants; very low-certainty evidence). Low-certainty evidence from three trials (174 participants) indicates cryotherapy may improve range of motion at discharge: it was 62.9 degrees with no cryotherapy and 71.2 degrees with cryotherapy: MD 8.3 degrees greater (95% CI 3.6 degrees more to 13.1 degrees more). We are uncertain whether cryotherapy improves function two weeks after surgery. Function was 75.4 points on the 0- to 100-point Dutch Western Ontario and McMaster Universities Arthritis Index (WOMAC) scale (lower score indicates worse function) in the control group and 88.6 points with cryotherapy (MD 13.2 points better, 95% CI 0.5 worse to 27.1 improved; 4 trials, 296 participants; very low-certainty evidence). We are uncertain whether cryotherapy reduces total adverse events: the risk ratio was 1.30 (95% CI 0.53 to 3.20; 16 trials, 1199 participants; very low-certainty evidence). Adverse events included discomfort, local skin reactions, superficial infections, cold-induced injuries and thrombolytic events. We are uncertain whether cryotherapy reduces withdrawals from adverse events (RR 2.71, 95% CI 0.42 to 17.38; 19 trials, 1347 participants; very low-certainty evidence). No significant benefit was found for secondary outcomes of analgesia use, length of stay, activity level or quality of life. Evidence from seven studies (403 participants) showed improved mid-patella swelling between two and six days after surgery (MD 7.32 mm less, 95% CI 11.79 to 2.84 lower), though not at six weeks and three months after surgery. The included studies did not assess participant-reported global assessment of success. AUTHORS' CONCLUSIONS: The certainty of evidence was low for blood loss, pain and range of motion, and very low for transfusion rate, function, total adverse events and withdrawals from adverse events. We are uncertain whether cryotherapy improves transfusion rate, function, total adverse events or withdrawals from adverse events. We downgraded evidence for bias, indirectness, imprecision and inconsistency. Hence, the potential benefits of cryotherapy on blood loss, pain and range of motion may be too small to justify its use. More well-designed randomised controlled trials focusing especially on clinically meaningful outcomes, such as blood transfusion, and patient-reported outcomes, such as knee function, quality of life, activity level and participant-reported global assessment of success, are required.

Comparing the efficacy of plasma exeresis and cryotherapy for the treatment of seborrheic keratosis: A randomized controlled trial.

BACKGROUND: Seborrheic keratoses (SK) is a benign epithelial skin tumor and plasma exeresis is a new technique. AIMS: To compare the efficacy and safety of plasma exeresis and cryotherapy for treating SK. METHODS: This study is a randomized controlled trial (RCT). One side of each patient was randomly treated with plasma exeresis (peak-to-peak voltage of 3.44 kV and a frequency of 62.5 kHz) and the other side with cryotherapy. RESULTS: Thirty-five males were enrolled. At week 3, 37.1 % (N = 13) of lesions treated by plasma exeresis were clear, which was higher than those treated by cryotherapy 17.1% (N = 6). However, this difference was not significant (p-value: 0.06). At week 6, 16 (57.1 %) out of 28 remaining lesions, treated by plasma exeresis were clear, which was significantly higher (p-value: 0.005) than those completely cleared by cryotherapy in 6 out of 29 remaining lesions (20.7%). The mean physician assessment scale score was significantly reduced in both groups in the second follow-up (plasma group first follow-up 0.91 ± 0.89 vs. second follow-up 0.5 ± 0.64 and p-value: 0.0031; cryo group first follow-up 1.4 ± 0.84 vs. second follow-up 1.1 ± 0.72 and p-value: 0.0002). Regarding side effects, no significant difference was seen (p = 0.438). The most common complications in the plasma and cryotherapy groups were erythema (10/19, 52.63%) and hypo pigmentation (5/13, 38.46%). CONCLUSIONS: Both cryotherapy and plasma exeresis are effective. We observed a significantly higher cleared lesions treated with plasma exeresis in 6 weeks and after two sessions.

Clinical Outcomes of Bronchoscopic Cryotherapy for Central Airway Obstruction in Adults: An 11-Years' Experience of a Single Center.

BACKGROUND: Although bronchoscopic cryotherapy (BC) is a pragmatic modality for recanalization of central airway obstruction (CAO), the risk of complications, such as bleeding, remains a concern. This study aimed to present the clinical outcomes of BC and evaluate the factors associated with its complications. METHODS: In this retrospective study, we reviewed the medical records of patients who underwent BC for CAO at the Asan Medical Center, South Korea. Most sessions were conducted via flexible bronchoscopy under moderate sedation. A multivariate logistic regression analysis was used to identify the factors associated with the success rate and complications. RESULTS: BC was performed in 262 sessions in 208 patients between January 2009 and December 2020. The most common cause of cryotherapy was recanalization of the endobronchial tumor related CAO (233/262, 88.9%). More than partial re-establishment of airway patency was achieved in 211 of 233 (90.6%) sessions. The success rate did not differ significantly in the multivariate logistic regression analysis. The most common complication was intrabronchial bleeding (78/233, 35.5%); however, severe bleeding occurred only in one case (0.4%). Univariate and multivariate logistic regression analyses revealed that diabetes mellitus (odds ratio [OR] = 2.820, P = 0.011), respiratory failure before BC (OR = 3.546, P = 0.028), and presence of distal airway atelectasis (OR = 0.417, P = 0.021) were independently associated with moderate to severe intrabronchial bleeding, while the histologic type of tumor was not related to bleeding. BC for CAO caused by blood clot or foreign body was successful in most cases, and there were no complications. CONCLUSION: BC is an efficient and relatively safe intervention for patients with CAO. Our findings suggest that diabetes, respiratory failure before BC, and the absence of distal airway atelectasis may be risk factors of moderate to severe intrabronchial bleeding.

Effectiveness of Cryotherapy on Cancer Therapy-Induced Oral Mucositis: An Umbrella Review.

BACKGROUND: Oral mucositis (OM) considerably affects the experience of patients with cancer during treatment. This study investigated the effects of cryotherapy on cancer therapy-induced OM. OBJECTIVE: This study aimed to systematically appraise evidence on whether cryotherapy can reduce the incidence and severity of OM. METHODS: We conducted an umbrella review to examine the effect of cryotherapy on cancer-related OM. The primary outcome was the incidence and severity of OM. We performed a subgroup analysis including solid cancers and hematological malignancies. RESULTS: Five meta-analyses were included. Cryotherapy could more effectively reduce the incidence of severe OM (risk ratio [RR], 0.37; 95% prediction interval [PI], 0.22-0.64). In the subgroup analyses of solid cancers or hematological malignancies, cryotherapy significantly reduced the incidence of grades 2 to 4 OM in patients with solid cancers (RR, 0.51; 95% PI, 0.34-0.78 and RR, 0.52; 95% PI, 0.36-0.74). However, no significant difference was observed in the incidence of OM in patients with hematological malignancies regarding any grade or grade 3 or 4 OM. Moreover, cryotherapy did not significantly reduce the OM duration (mean difference, -0.13; 95% PI, -20.89 to 20.63; mean difference, -2.99, 95% PI, -8.10 to 2.12). CONCLUSION: Cryotherapy can reduce the incidence of severe OM induced by chemotherapy or radiotherapy. IMPLICATION FOR PRACTICE: We recommend the inclusion of this safe, simple, and convenient intervention in chemotherapy or radiotherapy plans. Additional clinical trials are warranted to extend the limited evidence on the effectiveness of cryotherapy in reducing the severity and duration of OM.

The effect of adjuvant cryotherapy added to well-performed high-speed burr curettage on the long-term surgical outcomes of chondroblastoma cases.

OBJECTIVES: This study aims to investigate the effect of adjuvant cryotherapy added to well-performed high-speed burr curettage on the long-term surgical outcomes of chondroblastoma cases. PATIENTS AND METHODS: Between January 2004 and December 2020, a total of 30 chondroblastoma cases (19 males, 11 females; median age: 18.6 years; range, 9 to 53 years) who were surgically treated were retrospectively analyzed. The pressurized-spray technique was performed using liquid nitrogen. Data including age, sex, radiological appearance, treatment modality, duration of follow-up, skin problems, and recurrence were recorded. All patients received adjuvant liquid nitrogen cryotherapy after extended intralesional curettage with high-speed burr. The bone cavity was filled with an autologous iliac crest bone graft, allograft, or polymethylmethacrylate (PMMA). RESULTS: The median follow-up was 54 (range, 19 to 120) months. The lesion was located around the knee in 16 (53.3%), in the shoulder in seven (23.3%), around the hip in five (16.6%), and in the ankle in two (6.6%) cases. The defect was filled with an autologous iliac crest bone graft in 28 (93.3%), an additional allograft in eight (26.7%), and PMMA in two (6.7%) cases. Local recurrence was observed in only two (6.7%) patients during follow-up. Two (6.7%) patients developed physeal growth arrest. Osteoarthritic changes were observed in two (6.7%) patients (one knee and one hip) due to the periarticular location of the tumor. Three (10%) patients had skin complications. None of the cases had a pathological fracture. CONCLUSION: A well-performed extended intralesional curettage with high-speed burr is the first and essential step in treating chondroblastoma. Adding adjuvant liquid nitrogen cryotherapy with high-speed burr can improve treatment outcomes and significantly reduce the recurrence rate of this disease.

Intermediate-term oncological and functional outcomes of salvage cryotherapy for the management of prostate cancer recurrence after primary brachytherapy versus primary cryotherapy: A propensity score-matched analysis.

BACKGROUND: Salvage cryotherapy (SCT) is widely used to treat prostate cancer (PCa) recurrence after radiotherapy (RT). We studied the intermediate oncological and functional outcomes of patients who underwent SCT following cryotherapy (CRYO-SCT) recurrence and compare it to recurrence after brachytherapy (BT-SCT). METHODS: An IRB-approved retrospective cohort study utilizing patient data from the Cryo On-Line Data Registry and the Duke PCa database between 1992 and 2016. Biochemical recurrence (BCR) using Phoenix criteria was the primary endpoint assessed at 2- and 5-years post-SCT. Secondary endpoints assessed functional outcomes including urinary continence, erectile function, and recto-urethral fistula. Association between treatment and biochemical progression-free survival was assessed using inverse probability weighted (IPTW) Cox proportional hazards regression. The differences in the secondary functional outcomes were assessed by Pearson's χ2 test or Fisher's exact test, corrected for IPTW. RESULTS: A total of 194 patients met inclusion criteria. The BCR rate for BT-SCT and CRYO-SCT was 23 (20.4%) and 17 (21%) at 2 years and 30 (26.5%) and 22 (27.2%) at 5 years according to Phoenix criteria. There was no statistical difference in 2 years (hazard ratio [HR] 0.9; 95% confidence interval [CI], 0.5-1.7, p = 0.7) or 5-year BCR (HR: 0.86; 95% CI, 0.5-1.5, p = 0.6) between the groups. The functional outcomes like urinary continence (p = 0.4), erectile function (p = 0.1), and recto-urethral fistula (p = 0.3) were not statistically different. CONCLUSION: CRYO-SCT appears to be well tolerated, with comparable oncological and functional outcomes to patients failing primary BT. The findings also demonstrated that SCT can render a significant number of patients biochemically free of disease after initial CRYO with minimal morbidity. SCT is a viable treatment option to salvage local PCa recurrence following either BT or cryoablation failure.

A prospective multicenter study to evaluate the impact of cryotherapy on dysphagia and quality of life in patients with inoperable esophageal cancer.

BACKGROUND: Dysphagia palliation in inoperable esophageal cancer continues to be a challenge. Self-expandable metal stents have been the mainstay of endoscopic palliation but have a significant risk of adverse events (AEs). Liquid nitrogen spray cryotherapy is an established modality that can be used with systemic therapy. This study reports the outcomes of cryotherapy, including dysphagia and quality of life (QoL), in patients receiving systemic therapy. METHODS: This was a prospective multicenter cohort study of adults with inoperable esophageal cancer who underwent cryotherapy. QoL and dysphagia scores before and after cryotherapy were compared. RESULTS: 55 patients received 175 cryotherapy procedures. After a mean of 3.2 cryotherapy sessions, mean QoL improved from 34.9 at baseline to 29.0 at last follow-up (P < 0.001) and mean dysphagia improved from 1.9 to 1.3 (P = 0.004). Patients receiving more intensive cryotherapy (≥ 2 treatments within 3 weeks) showed a significantly greater improvement in dysphagia compared with those not receiving intensive therapy (1.2 vs. 0.2 points; P = 0.003). Overall, 13 patients (23.6 %) received another intervention (1 botulinum toxin injection, 2 stent, 3 radiation, 7 dilation) for dysphagia palliation. Within the 30-day post-procedure period, there were three non-cryotherapy-related grade ≥ 3 AEs (all deaths). The median overall survival was 16.4 months. CONCLUSION: In patients with inoperable esophageal cancer receiving concurrent systemic therapy, adding liquid nitrogen spray cryotherapy was safe and associated with improvement in dysphagia and QoL without causing reflux. More intensive treatment showed a greater improvement in dysphagia and should be considered as the preferred approach.

An Update on Focal Therapy for Prostate Cancer.

Radical treatments and active surveillance are valid therapeutic approaches for low-risk prostate cancer. The oncologic effectiveness and morbidity of Radical Prostatectomy (RP) and radiotherapy have been broadly validated. Focal therapies pursue to reduce the morbidity observed after radical treatments, while preserving the oncologic effectiveness. This study aims to review the state-of-the-art about principles, oncologic effectiveness, morbidity, and side-effects associated with leading focal therapies. We review and summarize articles related with Cryotherapy, High-Intensity Focal Ultrasound (HIFU), Photodynamic Therapy (PDT), and Irreversible Electroporating (IRE) published in MEDLINE from 2000 to 2022. There is a wide heterogeneity in terms of the measurement of effectiveness and morbidity. Hence, comparing different energies, strategies and protocols seem to be unprecise and controversial. Cryosurgery and HIFU have reported more clinical experience than PDT and IRE. Biochemical recurrence rate after the first session varied from 4.5% to 23%, and up to 20% of patients underwent a salvage radical treatment. The reported incidence of erectile disfunction and urinary incontinence ranges from 3% to 50% and 0% to 34%, respectively. None randomized clinical trial comparing any focal therapy to any radical treatment has been published. We conclude that the expansion of focal therapies requires the consolidation of MRI-guided fusion biopsies in everyday clinical practice. Short-term oncologic effectiveness has been proved and supports their usefulness in low-risk patients unfit for surgical treatment. However, long-term effects and the clinical experience in intermediate and high-risk patients remains limited. Currently none of the focal therapies can be considered the Gold Standard for low-risk patients.

Assessment of the Efficacy of Cryolipolysis on Abdominal Fat Deposits: A Prospective Study.

BACKGROUND: Cryolipolysis is a non-invasive and efficacious procedure for body contouring. The effectiveness of cryolipolysis has been demonstrated on multiple areas of the body, but on a limited number of subjects. The aim of this study is to demonstrate the effectiveness and the safety of cryolipolysis in the lower abdomen adipose tissue thickness reduction. METHODS: A prospective study on 60 healthy women was carried out using CryoSlim Hybrid device. Each patient underwent two cryolipolysis sessions centered on the abdominal area. The primary endpoint was to decrease the thickness of the abdominal fat deposits. The change in the abdominal circumference and the thickness of the subcutaneous fat layer were assessed. Patient satisfaction and tolerance of the procedure were also taken into account. RESULTS: A significant reduction of the abdominal circumference and subcutaneous fat layer thickness was observed. The mean decrease in abdominal circumference was 2.10 cm (3.1%) 3 months after the procedure and 4.03 cm (5.8%) 6 months after the procedure. The mean decrease in fat layer thickness was 1.25 cm (43.81%) 3 months after the procedure and 1.61 cm (41.73%) 6 months after the procedure. No major adverse events were noted. All patients were very satisfied, and minimal pain was reported. CONCLUSIONS: Cryolipolysis is an effective technique to treat abdominal localized fat deposits. No major adverse events have been described for this procedure. Our promising results should encourage further studies aimed at optimizing the efficacy of the procedure without a considerable increase in the risks. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors http://www.springer.com/00266 .

Active Heating following Cryolipolysis Reduces Efficacy and Side Effects: A Randomized Split-Body Trial.

BACKGROUND: Cryolipolysis-a popular noninvasive technique for body contouring-has fewer side effects compared with liposuction; however, its effectiveness in terms of reducing local adipose tissue is also lower. This study is, to the authors' knowledge, the first prospective, controlled, investigator-blinded split-body trial to evaluate whether postcryolipolytic heating can increase the efficacy. METHODS: Twenty-five subjects were treated with one session of cryolipolysis on the lower abdomen and a subsequent heating with a mud pack of a randomized side of the treated region (left or right). Epidemiologic, temperature, edema, erythema, hypesthesia, and pain level data were obtained. Photographs, fat layer thickness (on ultrasound, caliper, and abdominal girth), satisfaction, and side effects were documented over a follow-up period of 12 weeks. RESULTS: The side effects-edema, erythema, and hypesthesia-faded almost completely with heating, whereas they remained on the nonheated site. However, the mean sonographic reduction of local adipose tissue after 12 weeks was significantly lower on the heated sites than on the control sites (9.6% versus 14.1%; P = 0.0003). The overall satisfaction was high (9.2 of 10 points), even though only 44% of participants had a subjective recognition of fat loss without difference between the sites. CONCLUSIONS: Active heating following cryolipolysis increases bodily well-being by reducing common side effects, but it reduces the effectiveness of cryolipolysis significantly and should therefore be avoided. Further improvements are necessary to enhance the efficacy of cryolipolysis. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Efficacy of Cryotherapy and Hangeshashinto for Radiation-induced Oral Stomatitis: Preliminary Study.

BACKGROUND/AIM: Radiation-induced stomatitis is one of the main acute disorders in patients with head and neck cancer. Since its treatment is often delayed or discontinued, the control of perioperative oral function is necessary. It has been reported that Hangeshashinto (Japanese traditional herbal medicine) and cryotherapy (known as frozen therapy) alleviate oral stomatitis and the accompanying pain. In the present study, the combination effect of Hangeshashinto and cryotherapy on radiation-induced stomatitis in patients with head and neck cancers was investigated for the first time. PATIENTS AND METHODS: Fifty patients with head and neck cancer were subjected to radiation therapy with concomitant administration of anticancer drugs. They were separated into two groups, matched according to age, stage of cancer progression, total radiation dose, and type of concomitant anticancer drugs. One group was orally administrated frozen Hangeshashinto, while another group was not. Oral mucosal damage was assessed by the grade classification CTCAE v4.0 of the National Cancer Institute of the United States (Japanese JCOG version). Duration time of radiation-induced stomatitis was determined by the appearance of grade 1 redness to its disappearance. RESULTS: Frozen Hangeshashinto significantly alleviated, delayed the onset, and reduced the duration time of the radiation-induced stomatitis. CONCLUSION: Cryotherapy in combination with Hangeshashinto can be used for the treatment of radiation-induced oral stomatitis.

Effectiveness of Photobiomodulation and Oral Cryotherapy on Oral Mucositis Among Patients Undergoing Chemotherapy Conditioning Prior to Hematological Stem Cell Transplantation.

OBJECTIVES: This review evaluated the best available evidence concerning the effectiveness of photobiomodulation compared to oral cryotherapy in oral-mucositis prevention among patients with hematological stem cell transplantation (HSCT) receiving chemo-conditioning. DATA SOURCES: An extensive search for published and unpublished studies was conducted in 11 electronic databases and reference lists. Only randomized controlled trials (RCTs) were included. Two reviewers independently screened relevant studies for eligibility, extracted data using a standardized data collection form, and appraised data using the Cochrane Risk of Bias Tool and Grading Recommendations, Assessment, Development and Evaluation (GRADE). Meta-analyses using a random-effect model was performed using Review Manager software. Subgroup analyses were conducted to examine the differential effect of interventions across subgroups and to explore potential sources of heterogeneity. Meta-analyses included 18 RCTs (involving 1,018 patients). Both photobiomodulation and cryotherapy were effective in reducing oral-mucositis severity, severe oral-mucositis incidence, duration, and pain with small to large effect sizes. No significant differences were detected between photobiomodulation and cryotherapy across all outcomes. Subgroup analyses showed significant differences for chemo-conditioning regimens. The overall Grading Recommendations, Assessment, Development and Evaluation quality of evidence was low. CONCLUSION: Both photobiomodulation and cryotherapy were effective nonpharmacological oral-mucositis prophylaxis and analgesia, with no significant difference in effectiveness. Chemo-conditioning regimens may influence their effectiveness. Future RCTs may directly compare the effectiveness of photobiomodulation and cryotherapy on the HSCT patients. Rigorous cost-effectiveness studies are also required. IMPLICATIONS FOR NURSING PRACTICE: Photobiomodulation and cryotherapy can be offered to HSCT patients in clinical settings. A clinical guideline of both interventions can be also developed.

Cryotherapy for partial gland ablation of prostate cancer: Oncologic and safety outcomes.

BACKGROUND: Partial gland ablation (PGA) is a new option for treatment of prostate cancer (PCa). Cryotherapy, an early method of PGA, has had favorable evaluations, but few studies have employed a strict protocol using biopsy endpoints in men with clinically significant prostate cancer (csPCa). METHODS: 143 men with unilateral csPCa were enrolled in a prospective, observational trial of outpatient PGA-cryotherapy. Treatment was a 2-cycle freeze of the affected prostate part. Participants were evaluated with MRI-guided biopsy (MRGB) at baseline and at 6 months and 18 months after treatment. Absence of csPCa upon MRGB was the primary endpoint; quality-of-life at baseline and at 6 months after treatment was assessed by EPIC-CP questionnaires in the domains of urinary and sexual function. RESULTS: Of the 143 participants, 136 (95%) completed MRGB at 6 months after treatment. In 103/136 (76%), the biopsy revealed no csPCa. Of the 103, 71 subsequently had an 18-month comprehensive biopsy; of the 71 with 18-month biopsies, 46 (65%) were found to have no csPCa. MRI lesions became undetectable in 96/130 (74%); declines in median serum PSA levels (6.9 to 2.5 ng/mL), PSA density (0.15 to 0.07), and prostate volume (42 to 34cc) were observed (all p < 0.01). Neither lesion disappearance on MRI nor PSA decline correlated with biopsy outcome. Urinary function was affected only slightly and sexual function moderately. CONCLUSION: In the near to intermediate term, partial gland ablation with cryotherapy was found to be a safe and moderately effective treatment of intermediate-risk prostate cancer. Eradication of cancer was better determined by MRI-guided biopsy than by MRI or PSA.

Safety and efficacy of the combination of cryotherapy and photodynamic modalities with imiquimod in patients with actinic keratosis: a systematic review and meta-analysis.

INTRODUCTION: Actinic keratosis (AK) is an intraepithelial tumor that, in most cases, arises in chronically sun-exposed areas. The combination of cryotherapy and photodynamic modalities with imiquimod has been proven to be a potential therapeutic option for AKs. However, there is no comprehensive systematic study that discussed this concept in literature taking into consideration both efficacy and safety. EVIDENCE ACQUISITION: We performed a comprehensive search of the literature for studies assessing the efficacy and toxicity of the combinatorial tripartite regimen, consisting of cryotherapy and photodynamic modalities with imiquimod in AK. Metanalysis was performed using comprehensive meta-analysis version 3.0. EVIDENCE SYNTHESIS: After the screening of 1031 studies, five studies were included. Two trials compared the effect of imiquimod/cryotherapy versus cryotherapy alone or versus cryotherapy/vehicle. Our meta-analysis indicated that imiquimod/cryotherapy effectively induces complete clinical clearance in patients with AKs (OR: 6.26; 95%CI: 1.56-24.1; P=0.01). Moreover, another two studies, which were not meta-analyzed, indicated a substantial clinical clearance in the number of AK lesions in the imiquimod plus photodynamic therapy arm as compared to 5% imiquimod or PDT alone. No serious systemic adverse events were reported in all the treatment arms. CONCLUSIONS: Combined PDT or cryotherapy with imiquimod is more effective in the complete recovery of AK than treatment with imiquimod alone.