Endoscopic polidocanol foam sclerobanding for the treatment of grade II-III internal hemorrhoids: A prospective, multi-center, randomized study.

BACKGROUND: Endoscopic rubber band ligation (ERBL) is a nonsurgical technique for the treatment of symptomatic internal hemorrhoids but is limited by recurrence and post-procedural pain. AIM: To evaluate satisfaction, long-term recurrence, and post-procedural pain in managing internal hemorrhoids using a combination of polidocanol foam sclerotherapy and ERBL. METHODS: This was a prospective, multicenter, randomized study. A total of 195 consecutive patients diagnosed with grade II-III internal hemorrhoids were enrolled from four tertiary hospitals and randomly divided into a cap-assisted endoscopic polidocanol foam sclerobanding (EFSB) or an ERBL group. All patients were followed-up for 12 months. Symptom-based severity and post-procedural pain were assessed using a hemorrhoid severity score (HSS) and a visual analog scale (VAS). Continuous variables were reported as medians and interquartile range. RESULTS: One hundred and ninety-five patients were enrolled, with 98 in the EFSB group. HSS was lower in the EFSB group than in the ERBL group at 8 weeks [4.0 (3.0-5.0) vs 5.0 (4.0-6.0), P = 0.003] and 12-month [2.0 (1.0-3.0) vs 3.0 (2.0-3.0), P < 0.001] of follow-up. The prolapse recurrence rate was lower in the EFSB group at 12 months (11.2% vs 21.6%, P = 0.038). Multiple linear regression analysis demonstrated that EFSB treatment [B = -0.915, 95% confidence interval (CI): -1.301 to -0.530, P = 0.001] and rubber band number (B = 0.843, 95%CI: 0.595-1.092, P < 0.001) were negatively and independently associated with the VAS score 24 hours post-procedure. The median VAS was lower in the EFSB group than in the ERBL [2.0 (1.0-3.0) vs 3.0 (2.0-4.0), P < 0.001]. CONCLUSION: Cap-assisted EFSB provided long-term satisfaction and effective relief from the recurrence of prolapse and pain 24 hours post-procedure.

Comparing mechanochemical endovenous ablation using Flebogrif with endovenous laser ablation in the treatment of primary great saphenous vein incompetence: protocol for a multicentre, open-label, non-inferiority, observer-blinded, randomised controlled trial (REBORN trial).

INTRODUCTION: Endovenous laser ablation (EVLA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. However, the use of thermal ablation requires tumescent anaesthesia and is associated with a risk of thermal damage. Mechanochemical endovenous ablation (MOCA) is a non-thermal ablation (NTA) alternative, which combines mechanical endothelial damage with the infusion of a sclerosant liquid or foam. Tumescent anaesthesia is not required. Preliminary experiences with MOCA using the Clarivein device show less intraprocedural and postprocedural pain and a faster clinical improvement compared with EVLA. Flebogrif (Balton, Poland) is a relatively new MOCA device. To determine the role of MOCA using Flebogrif, a well-designed, randomised controlled clinical trial of sufficient sample size and follow-up time is required. In this article, we provide the study protocol for the REBORN trial, aiming to demonstrate that MOCA using Flebogrif is not inferior to EVLA for the outcome of anatomical success in the treatment of GSV incompetence. METHODS AND ANALYSIS: This multicentre, open-label, non-inferiority, observer-blinded, randomised controlled trial randomises patients who are diagnosed with GSV incompetence and aged 18-80 years between Flebogrif and EVLA. 310 patients in 3 participating centres (Northwest Clinics Alkmaar, Skin and Vein Clinic Oosterwal Alkmaar and Red Cross Hospital Beverwijk) will be included. The primary outcome is anatomical success at 12 months. Secondary outcomes are intraprocedural pain, operation time, technical success, postprocedural pain, safety, anatomical success during other follow-up moments, complications, clinical success, aesthetic result, disease-specific quality of life, reinterventions, anterior accessory saphenous vein reflux and neovascularisation. Patients will be followed up at 1 week, 1, 6, 12, 24 and 60 month(s) after treatment. ETHICS AND DISSEMINATION: The institutional review board (Medical Ethical Review Committee of the Vrije Universiteit Medical Center) approved this study on 17 May 2021 under case number 2020.0740. Written informed consent is obtained by the coordinating investigator from all participants prior to study enrolment. After completion of the trial, the results will be submitted to an international scientific journal for peer-reviewed publication. TRIAL REGISTRATION NUMBER: Overzicht van Medisch-wetenschappelijk Onderzoek in Nederland, NL-OMON25145, previously NL9527; Centrale Commissie Mensgebonden Onderzoek, NL74491.029.20.

Percutaneous Sclerotherapy of Venous Malformations.

Venous malformation (VM) stands as the most prevalent form of vascular malformation, characterized by its diverse morphology. These lesions can manifest in any part of the body, affecting different tissue planes and giving rise to symptoms such as pain, swelling, or physical dysfunction. In the realm of treatment, direct puncture VM sclerotherapy holds its place as the primary approach. This technique involves the administration of a sclerosing agent into the VM channels during contrast phlebography while simultaneously managing the outflow veins through different methods. The process of VM sclerotherapy induces endothelial damage, thrombosis, and fibrosis, resulting in symptom relief through lesion shrinkage. It is crucial to exercise caution techniques and sclerosing agents during VM sclerotherapy to minimize procedural complications, enhance clinical outcomes, and ultimately improve the patient's overall quality of life.

Fibroadipose Vascular Anomaly: Diagnosis and Treatment.

Fibro-Adipose Vascular Anomaly (FAVA) is a recently identified type of vascular malformation predominantly affecting adolescent females. Comprising abnormal adipose and vascular components, FAVA is frequently misdiagnosed as other vascular anomalies. It primarily manifests with pain, functional impairment, and musculoskeletal symptoms, particularly in the lower extremities. Accurate diagnosis requires a combination of clinical, radiologic, and histopathologic evaluation, with MRI and ultrasound being the primary imaging tools. Management of FAVA is multidisciplinary and tailored to individual patients. Interventional radiology procedures, such as percutaneous cryoablation, sclerotherapy, and embolization, are effective in long term control of symptoms. Cryoablation is particularly successful in alleviating pain and improving function. Surgical resection is reserved for specific cases with extensive lesions involving joints or when there is severe muscle or joint dysfunction. Additionally, sirolimus, an mTOR inhibitor, has shown promise in symptom relief, although further research is needed to confirm its long-term efficacy. Early diagnosis and treatment are essential for improving the quality of life in FAVA patients. Advances in imaging and treatment strategies have enhanced the ability to manage this complex and rare condition effectively.

Endoscopic injection of lauromacrogol foam sclerotherapy for rectal cavernous hemangioma: A case report.

RATIONALE: Rectal cavernous hemangioma is a rare, benign vascular disease that seldom causes lower gastrointestinal bleeding, characterized by a high rate of misdiagnosis and missed diagnoses. Surgical treatment is considered to be relatively effective; however, it is accompanied by certain employed in the treatment of superficial hemangioma, boasting the advantages of minimally invasive surgery, including safety, effectiveness, reduced trauma, and rapid recovery. However, there is a lack of literature regarding the application of foam sclerosing agents for gastrointestinal hemangiomas. CASE CONCERNS: We present a case of a 60-year-old male who was admitted to our hospital with a history of recurrent hematochezia for >1 year and worsening symptoms for 1 week. The patient's medical history was unremarkable. DIAGNOSES: Following colonoscopy, nuclear magnetic resonance imaging, computed tomography, and other examinations, the final diagnosis was rectal cavernous hemangioma. INTERVENTIONS: Due to the patient's refusal of surgery, endoscopic foam sclerotherapy using a lauromacrogol injection was performed after obtaining informed consent from the patient and their relatives. OUTCOMES: Post-sclerotherapy, hematochezia symptoms ceased, and no adverse reactions were observed. Two months later, colonoscopy and nuclear magnetic resonance imaging showed that the hemangioma had almost completely disappeared, with only a small amount of tumor remnants, yielding a satisfactory curative effect. CONCLUSION: Our findings indicate that endoscopic injection of a lauromacrogol foam sclerosing agent is a safe, effective, and minimally invasive treatment option for gastrointestinal cavernous hemangiomas.

Sclerotherapy for the intraoral ranula with bleomycin: technical considerations and preliminary experience.

Ranula is a mucous cyst that occurs in the sublingual gland (SLG) in the floor of the mouth. It can be classified into two types based on origins: One is the the lesser sublingual gland (LSLG) in the anterior segment and the Rivini duct, which is connected to it, and the other is the greater sublingual gland (GSLG) in the posterior segment. Because of the anatomical characteristics, surgical resection of the cysts carries the risk of damaging adjacent tissues and has a high recurrence rate. Intralesional injection of sclerotherapy may be a better alternative treatment. We summarized 65 cases of ranula treated with intralesional injections of bleomycin(BML). According to the origin of the ranula, 60 cases were from the LSLG and the Rivini duct, and 5 cases were from the GSLG. The results showed that 60 cases of ranula from LSLG and Rivini ducts were 100% cured during the follow-up period. The median number of injections for all patients was 1.16. All 5 cases of ranula from the GSLG did not wholly recover. This study confirmed that BLM intralesional injection is a safe and effective treatment modality for cysts from LSLG or the ducts of Rivini rather than GSLG. Therefore, before treatment, it is necessary to determine the type and origin of the cyst by characterizing its morphology to ensure the effectiveness of the treatment.

Comparison of two ablation procedures combined with high ligation and foam sclerotherapy and compression therapy for patients with venous leg ulcers.

AIM: To compare the ablation techniques' efficacy of endovenous microwave ablation (EMA) combined with high ligation (HL), foam sclerotherapy (FS) and compression therapy (CT) and endovenous laser ablation (EVLA) combined with HL-FS-CT in the treatment of VLUs. METHOD: 301 consecutive patients with VLUs from 2013 to 2022 in a 3200-bed hospital were intervened by EMA combined with HL-FS-CT and EVLA combined with HL-FS-CT were retrospectively compared. RESULTS: One hundred thirty-four patients underwent EMA+HL-FS-CT and 167 patients underwent EVLA+HL-FS-CT. The primary outcome of the ulcer healing time was 1.45(0.75-1.5) months and 1.86(0.5-2.5) months, respectively, in the two groups (HR for ulcer healing was 1.26, 95% CI [0.96-1.66], p = 0.097). Secondary outcomes included that no significant difference was found in ulcer recurrence and GSV recanalization and complications between the two groups, and the postoperative VCSS and AVVQ were significantly lower than the baseline values in the respective groups (p = 0.0001). CONCLUSION: EMA+HL-FS-CT and EVLA+HL-FS-CT are both effective at treating VLUs. Both of the two comprehensive treatments were beneficial to the healing of ulcers, but no evidence showed which one was superior in the ulcer healing time.

Deep vein thrombosis after sclerotherapy and endovenous laser ablation of varicose veins - an observational study.

Background: The risk of developing deep vein thrombosis (DVT) after endovenous ablation of varicose veins varies in the literature. Little is known about the characteristics of this complication and associated factors. This study aimed: 1) to study the occurrence of DVT after ultrasound-guided foam sclerotherapy (UGFS) alone or combined with endovenous laser ablation (EVLA) for lower-limb varicose veins; 2) to identify factors associated with DVT. Patients and methods: The study included all outpatients aged 18 years or older who underwent UGFS and EVLA or UGFS alone at the University Hospital of Zurich between 2011 and 2015. Data were extracted from the hospital electronic medical record. Patients were surveyed about their level of pain after the procedure and their level of satisfaction with the procedure. Duplex ultrasound was used to assess the deep venous system 7-10 days and 6-8 months after the procedure. Regression analysis was used to examine the association of patient and procedure characteristics with the development of DVT. Results: A total of 334 patients (561 procedures performed in 393 different sessions) were included: 73% of the patients underwent combined UGFS and EVLA and 27% underwent UGFS alone. DVT occurred in 24 (7.2%) patients, of whom 88% underwent combined procedures and 17% underwent interventions involving both the great and small saphenous veins on the same session. DVT occurred in 8.2% of patients receiving thromboprophylaxis and in 9.5% of patients not receiving thromboprophylaxis. DVT occurred in 5.2% of women and 11.9% of men. No factors associated with a diagnosis of DVT after intervention were identified. Pain and satisfaction levels did not differ between patients with and without DVT. Conclusions: This study adds to the knowledge of the risk of DVT following UGFS alone or combined with EVLA. Further studies are needed to revise thromboprophylaxis.

Outcomes and Recurrence Rate of Esophageal Varices after Endoscopic Treatment in Patients with Alcoholic Cirrhosis and Viral Cirrhosis.

BACKGROUND: The incidence of alcoholic liver cirrhosis (ALC) is increasing. However, few reports have focused on ALC-derived esophageal varices (EV). We retrospectively examined differences in overall survival (OS) and EV recurrence rate in patients after endoscopic injection sclerotherapy (EIS) for ALC and hepatic B/C virus liver cirrhosis (B/C-LC). METHODS: We analyzed data from 215 patients (B/C-LC, 147; ALC, 68) who underwent EIS. The primary endpoints were OS and EV recurrence in patients with unsuccessful abstinence ALC and those with uncontrolled B/C-LC, before and after propensity score matching (PSM) to unify the patients' background. The secondary endpoints were predictors associated with these factors, as determined by multivariate analysis. RESULTS: The observation period was 1,430 ± 1,363 days. In the analysis of all patients, OS was significantly higher in the ALC group than in the B/C-LC group (p = 0.039); however, there was no difference in EV recurrence rate (p = 0.502). Ascites and history of hepatocellular carcinoma (HCC) (p = 0.019 and p < 0.001, respectively) predicted OS, whereas age and EV size predicted recurrence (p = 0.011 and 0.024, respectively). In total, 96 patients without an HCC history were matched by PSM, and there was no significant difference in OS or EV recurrence rate (p = 0.508 and 0.246, respectively). CONCLUSION: When limited to patients without a history of HCC, OS and the EV recurrence rate were comparable in patients with ALC who continued to consume alcohol and those with B/C-LC without viral control.

Efficacy and safety of antegrade sclerotherapy for varicocele in pediatric patients: A systematic review.

OBJECTIVES: Antegrade sclerotherapy (Tauber's) procedure has been extensively used for the minimally-invasive treatment of varicocele; however, the results in the pediatric population are less defined. This systematic review evaluates the efficacy and safety of antegrade sclerotherapy for varicocele in the pediatric population. EVIDENCE ACQUISITION: The review was conducted following the PRISMA guidelines. Systematic research of available literature in English language from 1980 until May 2022 was conducted through EMBASE, MEDLINE, Cochrane Library, and NIH Registry of Clinical Trials. For each study, information was gathered regarding the study design, the inclusion/exclusion criteria, the indications for treatment, the success rate and the complications. When available, the details about sperm analysis were reported. EVIDENCE SYNTHESIS: The 10 studies were included in the final sample (564 patients). Median age of patients ranged 13.3-15.3 years. The indications for scleroembolization varied in the different studies, while most studies included patients with clinical G2-G3 varicocele and clinical symptoms or testicular asymmetry. The treatment was successful in 88%-98% of the patients, while the complication rate was <5%. CONCLUSION: Tauber's sclerotherapy is a safe and effective treatment for varicocele also in the pediatric population. Further studies with standardized inclusion criteria are needed to provide higher level of evidence and compare the outcomes of antegrade sclerotherapy with the other available techniques.

The efficacy of sclerotherapy as the initial treatment in patients with bleeding from Dieulafoy's lesion of the upper gastrointestinal tract.

BACKGROUND: Dieulafoy's lesion (DL) is a rare and important cause of acute nonvariceal upper gastrointestinal bleeding (ANVUGIB), however, there is a lack of clear guidelines focus on the endoscopic hemostasis treatment for DL. Sclerotherapy, as the ANVUGIB guideline recommended endoscopic hemostasis method, is widely used in clinical practice. The aim of this study is to investigate the efficacy of sclerotherapy as the initial treatment for Dieulafoy's lesion of the upper gastrointestinal tract (UDL). METHODS: Patients with UDL who underwent the ANVUGIB standard endoscopic hemostasis between April 2007 and January 2023 were enrolled. The endoscopic therapy method was left to the discretion of the endoscopist. RESULTS: In total, 219 patients were finally obtained, with 74 (33.8%) receiving sclerotherapy and 145 (66.2%) receiving other standard endoscopic therapy. The rebleeding within 30 days was significantly lower in the sclerotherapy group compared to the other standard group (5.8% vs. 16.8%, p = 0.047). There were no significant differences between the two groups in terms of successful hemostasis rate (93.2% vs. 94.5%, p = 0.713), median number of red blood cell transfusions (3.5 vs. 4.0 units, p = 0.257), median hospital stay (8.0 vs. 8.0 days, p = 0.103), transferred to ICU rate (8.1% vs. 6.2%, p = 0.598), the need for embolization or surgery rate (12.2% vs. 9.7%, p = 0.567) and 30-day mortality (0 vs. 2.1%, p = 0.553). In addition, we found no difference in efficacy between sclerotherapy alone and combination (3.1% vs. 8.1%, p = 0.714). Further analysis revealed that thermocoagulation for hemostasis was associated with a higher rate of rebleeding (28.6% vs. 3.1%, p = 0.042) and longer hospital stay (11.5 vs. 7.5 days, p = 0.005) compared to sclerotherapy alone. CONCLUSION: Sclerotherapy represents an effective endoscopic therapy for both alone and combined use in patients with upper gastrointestinal Dieulafoy's lesion. Therefore, sclerotherapy could be considered as initial treatment in patients with bleeding of UDL.

[Hydrocele]. / Hydrozele.

The hydrocele is overall a rare condition in urology. A differentiation between primary and secondary hydrocele is essential for further treatment. A primary hydrocele with a patent vaginal process tends to spontaneously regress in the first 2 years of life in newborns. If treatment is necessary, open as well as laparoscopic methods are available with good results. The treatment of scrotal pathologies, especially secondary hydrocele, often poses a challenge in the clinical practice. Despite the benign nature, supposedly simple surgical techniques and good chances of healing, postoperative complications are frequent. In comparison to open surgery, sclerotherapy provides a good alternative for the treatment of secondary hydrocele.

Interdisciplinary Management of Vascular Anomalies in the Head and Neck. / Interdisziplinäres Management vaskulärer Anomalien im Kopf-Hals-Bereich.

Vascular anomalies in the head and neck area are usually rare diseases and pose a particular diagnostic and therapeutic challenge. They are divided into vascular tumours and vascular malformations. A distinction is made between benign tumours, such as infantile haemangioma, and rare malignant tumours, such as angiosarcoma. Vascular malformations are categorised as simple malformations, mixed malformations, large vessel anomalies and those associated with other anomalies. Treatment is interdisciplinary and various modalities are available. These include clinical observation, sclerotherapy, embolisation, ablative and coagulating procedures, surgical resection and systemic drug therapy. Treatment is challenging, as vascular anomalies in the head and neck region practically always affect function and aesthetics. A better understanding of the genetic and molecular biological basis of vascular anomalies has recently led to clinical research into targeted drug therapies. This article provides an up-to-date overview of the diagnosis, clinic and treatment of vascular anomalies in the head and neck region.

Safety and efficacy of intralesional polidocanol sclerotherapy in the treatment of plantar warts: a pilot study.

Plantar warts are common skin lesions that continue to represent a therapeutic challenge. They are still resistant to therapy and are highly recurrent, despite the diverse number of treatments available. Therapies targeting vasculature, such as pulsed dye laser, have been used successfully in the treatment of plantar warts. Polidocanol, a detergent sclerosant approved for the sclerotherapy of incompetent and dilated saphenous veins, has also been used as an off-label therapy for a wide range of skin conditions with vascular components such as hemangiomas and pyogenic granuloma. The current, open-label, prospective, pilot study aimed to evaluate the safety and efficacy of the intralesional polidocanol 3% in the treatment of plantar warts. Twenty patients (11 females and 9 males), with plantar warts, aged 12-50 years received biweekly sessions of intralesional polidocanol 3% until complete clearance or for a maximum of 6 sessions. Response to treatment was graded as complete (100% clearance), partial (50-99%), and no response (< 50%). At the end of the study, 12 (60%) patients achieved complete clearance of their warts after 1-5 sessions, 5 (25%) patients had only partial response, and 3 (15%) patients did not achieve any clearance of their warts. The procedure was largely tolerable by patients. Pain at the injection site and bruises were reported by 9 (45%) and 2 (10%) patients, respectively. Both side effects resolved spontaneously and completely within a few days. The findings of the current study suggest that intralesional injection of 3% polidocanol in biweekly sessions may be a safe, effective, and tolerable method for the treatment of plantar warts.

[Varicosis-Current treatment concepts]. / Varikosis ­ aktuelle Therapiekonzepte.

Varicosis is a chronic progressive disease characterized by varicose veins of the lower extremities. Pain, swelling and heaviness of the legs are typical symptoms. These symptoms are caused by a pathological venous reflux, arising from a weakness of the vein wall and progressive venous insufficiency. The indications for invasive surgery are the symptomatic clinical, etiological, anatomical, pathophysiological (CEAP) stages C2s-C6. Compression therapy and venoactive drugs can be recommended for conservative therapy. When it comes to surgical treatment conventional open vein surgery is associated with the best long-term results. Endovenous thermal ablation is associated with few postoperative complications and favors earlier mobilization of the patient. Sclerotherapy has become established with good clinical results for the ablation of reticular and telangiectatic veins, for recurrences and complicated vein anatomy.

Polidocanol-foam treatment of varicose veins: Quality-of-life impact compared to conventional surgery.

BACKGROUND AND OBJECTIVE: Lower limb varicose veins are a prevalent disease associated with several available treatment options, including conventional surgery and polidocanol foam sclerotherapy. However, few studies have analyzed therapeutic modality outcomes based on Patient-Reported Outcome Measures (PROMs). This large sample-size study was designed to evaluate the outcomes of polidocanol foam sclerotherapy compared to conventional surgery based on an analysis of PROMs. METHODS: This was a prospective, observational, and qualitative study of 205 patients who underwent varicose vein treatment with either polidocanol foam sclerotherapy (57 patients, 90 legs) or conventional surgery (148 patients, 236 legs). Patients were preoperatively assessed and re-evaluated 30 days after the procedure using the Venous Disease Severity Score (VCSS) and specific venous disease quality-of-life questionnaires (VEINES-QoL/Sym). RESULTS: Both treatments significantly improved VCSS and VEINES results 30 days after the procedure (p < 0.05). However, surgery promoted greater improvements in VCSS (on average 4.02-points improvement, p < 0.001), VEINES-QoL (average 8-points improvement, p < 0.001), and VEINES-Sym (average 11.66 points improvement, p < 0.001) than did sclerotherapy. Postoperative pain and aesthetic concerns about the legs were the domains of the questionnaires in which the results varied the most between the treatment modalities, with worse results for sclerotherapy. CONCLUSION: Both polidocanol foam sclerotherapy and conventional surgery positively impact patients' quality of life after 30 days, but the improvement is more significant for patients who undergo conventional surgery.

Pycnogenol® prevents skin hyperpigmentation following sclerotherapy.

BACKGROUND: The aim of this registry supplement study was to evaluate the effects of the oral supplement Pycnogenol® on possible skin discolorations or other minor skin changes after varicose vein sclerotherapy in comparison with a standard management (SM). METHODS: One hundred sixty-one subjects completed the study. 84 took Pycnogenol® from the day before sclerotherapy for 12 weeks and followed SM. 77 followed SM only and served as controls. 420 injection sites were followed-up in the Pycnogenol® group and 431 in the control group. The number of injected veins (using only Aetoxysklerol) was on average 4-8 veins/patient. No side effects were observed for the SM or for supplementation. Pycnogenol® supplementation showed a good tolerability. The two management groups were comparable for age, sex and veins distribution at inclusion. RESULTS: After 12 weeks, skin discoloration assessed by a skin staining score was generally significantly lower and less frequent (P<0.05) with Pycnogenol® with a score of 0.4±0.2 compared to controls (with a score of 2.1±0.4). In addition, the number of stains per treated vein was significantly lower in the Pycnogenol® group than the control group. CONCLUSIONS: Varicose vein sclerotherapy is a minimally invasive procedure almost without complications. Pycnogenol® intake appears to improve healing and prevent skin discolorations after injection of the sclerosing agent. To verify this effect of Pycnogenol®, more studies for a longer period are needed.