Polidocanol Sclerotherapy in Pyogenic Granulomas.

BACKGROUND: Polidocanol is a safe sclerosing agent with anesthetic properties and minimal skin toxicity. OBJECTIVE: To evaluate the efficacy, safety, and recurrence rates with polidocanol sclerotherapy in the treatment of pyogenic granulomas (PGs). METHODS AND METHODS: Thirty-nine patients with PG were injected with polidocanol 1% solution. Repeat injections were given weekly in case of incomplete clinical/dermoscopic resolution, until a maximum of 3 sittings. A higher strength (3%) was used for subsequent sessions in those with a minimal response to 1% solution. A final assessment for relapses was performed at 3, 6, and 12 months. RESULTS: All 39 patients achieved complete resolution (100% clearance rate), with most (n = 26) lesions resolving after the first sitting. Side effects noted were postprocedure pain (22), erythema (2), superficial ulceration (2), paresthesias (1), prominent edema (4), thrombophlebitis (1), cyanotic discoloration (1), purpuric staining around injection site (4), and mild local pruritus (1). The procedure was well tolerated across the age spectrum (4-63 years) included. CONCLUSION: We report polidocanol to be a highly effective, safe, and cost-effective sclerosant for treatment of PGs with no recurrences or need for special postprocedure care.

Does Sericin, as a Novel Pleurodesis Agent, Have Higher Effectiveness Compared to Talcum Powder, Doxycycline, and Silver Nitrate Pleurodesis?

INTRODUCTION: The usefulness of sericin as pleurodesis agent has previously been described. Present study aims to compare sericin pleurodesis regarding success, effectiveness, tolerability, and side-effects. METHODS: Adult, 12-week-old Wistar-albino rats (n=60), divided to five groups as sericin, talcum-powder, doxycycline, silver-nitrate and control. Agents were administrated through left thoracotomy, rats sacrificed twelve-days after. RESULTS: Highest ratio of collagen fibers was observed in sericin group, and the intensity was higher than talcum-powder group (p<0.05). Compared to silver nitrate, sericin group displayed better mesothelial reaction, and multi-layer mesothelium was also better (p<0.05). Foreign body reaction and emphysema were less frequent in sericin group (p<0.05). The presence of biological tissue in parenchyma was less prominent in sericin group (p<0.05). Foreign body reaction on thoracic wall was less common in sericin group (p<0.05). Presence of biological tissue glue in thoracic wall was less prominent in sericin group (p<0.05). Glomerular degeneration was lower in sericin group compared to the silver nitrate group (p<0.05), and tubular degeneration was less common in sericin group than talcum group (p<0.05). Pericarditis was less common in sericin group compared to the other groups (p<0.05). CONCLUSION: As an intrinsic, natural glue protein, sericin protects the lung parenchyma and tissues, and its glue-like characteristics enable pleurodesis. The success of sericin in pleurodesis was demonstrated in the present study based on investigations of the pleurae. Being cost-effective and better tolerated agent associated with a low potential of side effects, sericin is more effective, less expensive and provides more lung parenchyma protection.

Transparent cap-assisted endoscopic sclerotherapy in esophageal varices: a randomized-controlled trial.

BACKGROUND AND AIM: Endoscopic treatment is widely accepted as the first-line therapy selection for esophageal variceal bleeding. Nevertheless, endoscopic injection sclerotherapy requires experienced endoscopists and is associated with a high risk of bleeding. Our study evaluates the feasibility and efficacy of transparent cap-assisted endoscopic sclerotherapy in the management of esophageal varices. PATIENTS AND METHODS: A randomized-controlled trial was conducted in a tertiary referral center from April 2015 to May 2016. Patients who received endoscopic sclerotherapy were randomized in a blinded manner into two groups: the transparent cap-assisted group (n=59) and the control group (n=61). RESULTS: The average injection sites were reduced in the transparent cap-assisted group compared with the control group (1.2±0.4 vs. 1.4±0.05, P=0.000), whereas no difference was observed in the dosage of lauromacrogol (16.97±4.91 vs. 16.85±4.57, P=0.662) and the hemorrhage that occurred during injection made no difference (50.8 vs. 61.0%, P=0.276); yet, salvage hemostasis methods were used in only nine patients in the transparent cap-assisted group compared with 17 patients in the control group (25.0 vs. 38.7%, P=0.0936). The cost of each procedure in the cap-assisted group was ¥2578 (1878-4202), whereas it was ¥3691 for the control group (2506-5791) (P=0.023). Moreover, in both groups, no esophageal constriction was observed during the 6-month follow-up period, whereas the rebleeding rate between two groups showed no statistical significance in 6 months (89.8 vs. 93.4%, P=0.563). CONCLUSION: Transparent cap-assisted sclerotherapy provided a clear field of vision and helped to fix the targeted veins, thus significantly reducing the use of the salvage hemostasis method during sclerotherapy injection hemorrhage. It is also associated with reduced injection sites and endoscopic therapy cost.

Comparison of Ultrasound-Guided Percutaneous Polidocanol Injection Versus Percutaneous Ethanol Injection for Treatment of Benign Cystic Thyroid Nodules.

OBJECTIVES: We compared the efficacy, safety, and cost-effectiveness of ultrasound-guided percutaneous polidocanol injection and percutaneous ethanol injection for the treatment of benign cystic and predominantly cystic thyroid nodules. METHODS: A total of 135 cystic thyroid nodules treated by percutaneous ethanol injection and 136 cystic thyroid nodules treated by percutaneous polidocanol injection were enrolled retrospectively in this study from May 2010 to March 2016. The nodules were followed after 1, 3, 6, and 12 months. Nodule volumes, symptoms scores, and cosmetic scores were assessed before treatment and at follow-up. The therapeutic success rate, safety, and cost-effectiveness between the groups were also compared. RESULTS: No significant differences in the reduction of the nodule volume, volume reduction rate, and therapeutic success were observed between the groups with cystic and predominantly cystic thyroid nodules during follow-up (P > .05). Neither the cosmetic scores (P = .59; P = .42) nor the symptom scores (P = .32; P = .73) in the cystic and predominantly cystic nodules were significantly different between the groups at the last follow-up. The complication rates for ethanol were higher than those for polidocanol (P < .05). However, the cost of polidocanol injection was higher than that of ethanol injection for cystic thyroid nodules (mean ± SD, US$97.18 ± US$22.17 versus US$43.36 ± US$5.51; P < .01). CONCLUSIONS: Ultrasound-guided percutaneous polidocanol injection can be an alternative for sclerotherapy of cystic or predominantly cystic thyroid nodules. However, its cost was higher than that of percutaneous ethanol injection.

Prospective Randomized Study of Ultrasound-Guided Foam Sclerotherapy Combined with Great Saphenous Vein High Ligation in the Treatment of Severe Lower Extremity Varicosis.

BACKGROUND: To evaluate the effect of ultrasound-guided foam sclerotherapy (UGFS) in a single session combined with great saphenous vein (GSV) high ligation for severe lower extremity varicosis classified as C4-C6, compared with GSV stripping plus multistab avulsion or transilluminated powered phlebectomy (TIPP). METHODS: From January 2012 to December 2014, 177 patients with primary GSV insufficiency, classified as C4-C6, were randomized into the UGFS group or the control group. The UGFS group was managed by GSV high ligation and foam sclerotherapy in one session under the surveillance of ultrasonography, whereas the control group received GSV high ligation and stripping combined with multistab avulsion or TIPP. The patients were followed up at 1, 6, and 12 months after treatment. Outcome assessments included reflux recurrence rate, procedure-related adverse events, hemodynamic parameters, revised Venous Clinical Severity Score (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ) score. The medical cost and operating time of the 2 groups were also compared. RESULTS: In total, 73 patients received UGFS, whereas 90 patients underwent traditional surgery. Sixty-five patients in the UGFS group (89.0%) and 74 patients in the control group (82.2%) completed the follow-up. At the end of 12 months, the cumulative reflux recurrence rate was 13.8% in the UGFS group and 13.5% in the control group (P = 0.955). In the UGFS and control groups, minor complications (27.7% vs. 21.6%, P = 0.406) and major complications (3.1% vs. 2.7%, P = 0.895) were not significantly different. Compared with baseline values, obvious improvements of the venous filling index, VCSS, and AVVQ scores after treatment were confirmed in both groups (P < 0.001). The average operating and recovery times were much shorter (38.3 vs. 81.2 min, 5.4 vs. 9.6 days, P < 0.001, respectively), and the average hospital cost was much lower ($853 vs. $1,575, P < 0.001) in the UGFS group than in the control group. The patient satisfaction rate reached 92.3% in the UGFS group and 89.2% in the control group 12 months after operation (P = 0.270). CONCLUSIONS: Our outcomes indicated that UGFS combined with GSV high ligation was safe and effective for severe lower extremity varicosis.

Venous leakage treatment revisited: pelvic venoablation using aethoxysclerol under air block technique and Valsalva maneuver.

OBJECTIVE: We evaluated the effectiveness of pelvic vein embolization with aethoxysclerol in aero-block technique for the treatment of impotence due to venous leakage in men using sildenafil for intercourse. The aim of the procedure was to reduce the use of sildenafil. METHODS: A total of 96 patients with veno-occlusive dysfunction, severe enough for the need of PDE5 inhibitors for vaginal penetration, underwent pelvic venoablation with aethoxysclerol. The mean patient age was 53.5 years. Venous leaks were identified by Color Doppler Ultrasound after intracavernous alprostadil injection. Under local anesthesia a 20-gauge needle was inserted into the deep dorsal penile vein. The pelvic venogram was obtained through deep dorsal venography. Aethoxysclerol 3% as sclerosing agent was injected after air-block under Valsalva manoeuver. Success was defined as the ability to achieve vaginal insertion without the aid of any drugs, vasoactive injections, penile prosthesis, or vacuum device. Additionally, a pre- and post- therapy IIEF score and a digital overnight spontaneous erections protocol (OSEP) with the NEVA™-system was performed. RESULTS: At 3 month follow-up 77 out of 96 patients (80.21%) reported to have erections sufficient for vaginal insertion without the use of any drug or additional device. Four (4.17%) patients did not report any improvement. Follow up with color Doppler ultrasound revealed a new or persistent venous leakage in 8 (8.33%) of the patients. No serious complications occurred. CONCLUSIONS: Our new pelvic venoablation technique using aethoxysclerol in air-block technique was effective, minimally invasive, and cost-effective. All patients were able to perform sexual intercourse without the previously used dosage of PDE5 inhibitor. This new method may help in patients with contra-indications against PDE5 inhibitors, in patients who cannot afford the frequent usage of expensive oral medication or those who do not fully respond to PDE5-inhibitors.

What is the clinical effectiveness and cost-effectiveness of conservative interventions for tendinopathy? An overview of systematic reviews of clinical effectiveness and systematic review of economic evaluations.

BACKGROUND: Lateral elbow tendinopathy (LET) is a common complaint causing characteristic pain in the lateral elbow and upper forearm, and tenderness of the forearm extensor muscles. It is thought to be an overuse injury and can have a major impact on the patient's social and professional life. The condition is challenging to treat and prone to recurrent episodes. The average duration of a typical episode ranges from 6 to 24 months, with most (89%) reporting recovery by 1 year. OBJECTIVES: This systematic review aims to summarise the evidence concerning the clinical effectiveness and cost-effectiveness of conservative interventions for LET. DATA SOURCES: A comprehensive search was conducted from database inception to 2012 in a range of databases including MEDLINE, EMBASE and Cochrane Databases. METHODS AND OUTCOMES: We conducted an overview of systematic reviews to summarise the current evidence concerning the clinical effectiveness and a systematic review for the cost-effectiveness of conservative interventions for LET. We identified additional randomised controlled trials (RCTs) that could contribute further evidence to existing systematic reviews. We searched MEDLINE, EMBASE, Allied and Complementary Medicine Database, Cumulative Index to Nursing and Allied Health Literature, Web of Science, The Cochrane Library and other important databases from inception to January 2013. RESULTS: A total of 29 systematic reviews published since 2003 matched our inclusion criteria. These were quality appraised using the Assessment of Multiple Systematic Reviews (AMSTAR) checklist; five were considered high quality and evaluated using a Grading of Recommendations, Assessment, Development and Evaluation approach. A total of 36 RCTs were identified that were not included in a systematic review and 29 RCTs were identified that had only been evaluated in an included systematic review of intermediate/low quality. These were then mapped to existing systematic reviews where further evidence could provide updates. Two economic evaluations were identified. LIMITATIONS: The summary of findings from the review was based only on high-quality evidence (scoring of > 5 AMSTAR). Other limitations were that identified RCTs were not quality appraised and dichotomous outcomes were also not considered. Economic evaluations took effectiveness estimates from trials that had small sample sizes leading to uncertainty surrounding the effect sizes reported. This, in turn, led to uncertainty of the reported cost-effectiveness and, as such, no robust recommendations could be made in this respect. CONCLUSIONS: Clinical effectiveness evidence from the high-quality systematic reviews identified in this overview continues to suggest uncertainty as to the effectiveness of many conservative interventions for the treatment of LET. Although new RCT evidence has been identified with either placebo or active controls, there is uncertainty as to the size of effects reported within them because of the small sample size. Conclusions regarding cost-effectiveness are also unclear. We consider that, although updated or new systematic reviews may also be of value, the primary focus of future work should be on conducting large-scale, good-quality clinical trials using a core set of outcome measures (for defined time points) and appropriate follow-up. Subgroup analysis of existing RCT data may be beneficial to ascertain whether or not certain patient groups are more likely to respond to treatments. STUDY REGISTRATION: This study is registered as PROSPERO CRD42013003593. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

An analysis of 72% chromated glycerin used for sclerotherapy: sterility, potency, and cost after extended shelf life.

BACKGROUND: Sclerotherapy is the treatment of reticular veins and telangiectasias of the lower extremities. Sclerosants destroy endothelial tissue and expose subendothelial collagen fibers, which lead to subsequent fibrosis of vessels, thus preventing recanalization. There are several available sclerosants including sodium tetradecyl sulfate (STS), polidocanol (POL), and chromated glycerin (CG) with varying efficacy, potency, side effect profile, and cost. OBJECTIVE: To identify the possible bacterial contamination and potency of CG beyond the current recommended shelf life of 3 months and to prove if CG is as cost effective as other available sclerosants. METHODS: Samples of 72% CG underwent bacterial endotoxin, sterility, and potency analysis at Days 0, 24, and 183. In addition, cost comparison was performed with other commercially available sclerosants including STS and POL. RESULTS: No samples of CG showed any bacterial contamination. All aliquots of glycerin remained sterile at Day 14. Potency at Day 24 was 99.2%, which was the same at Day 183. Cost comparison with other sclerosants revealed that CG is lower cost per milliliter than STS and POL. CONCLUSION: Seventy-two percent CG has no contamination and maintains its reported potency up to 6 months while comparable with the cost of other commercially available sclerosants.

Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein.

BACKGROUND: New minimally invasive treatment modalities, such as ultrasound-guided foam sclerotherapy (UGFS), are becoming more popular. In a multicentre randomized controlled non-inferiority trial, the effectiveness and costs of UGFS and surgery for treatment of the incompetent great saphenous vein (GSV) were compared. METHODS: Patients with primary great saphenous varicose veins were assigned randomly to either UGFS or surgical stripping with high ligation. Recurrence, defined as reflux combined with venous symptoms, was determined on colour duplex scans at baseline, 3 months, 1 year and 2 years after initial treatment. Secondary outcomes were presence of recurrent reflux (irrespective of symptoms), reduction of symptoms, health-related quality of life (EQ-5D(™)), adverse events and direct hospital costs. RESULTS: Two hundred and thirty patients were treated by UGFS and 200 underwent GSV stripping. The 2-year probability of recurrence was similar in the UGFS and surgery groups: 11·3 per cent (24 of 213) and 9·0 per cent (16 of 177) respectively (P = 0·407). At 2 years, reflux irrespective of venous symptoms was significantly more frequent in the UGFS group (35·0 per cent) than in the surgery group (21·0 per cent) (P = 0·003). Mean(s.d.) hospital costs per patient over 2 years were €774(344) per patient for UGFS and €1824(141) for stripping. CONCLUSION: At 2-year follow-up, UGFS was not inferior to surgery when reflux associated with venous symptoms was the clinical outcome of interest. UGFS has the potential to be a cost-effective approach to a common health problem. Registration numbers: NCT01103258 (http://www.clinicaltrials.gov) and NTR654 (http://www.trialregister.nl).

Polidocanol foam sclerotherapy is a new and effective treatment for post-operative lymphorrhea and lymphocele.

BACKGROUND: The formation of post-operative lymphocele and lymphorrhea following lymph node surgery is a potentially serious complication. Until now there has been no consensus on the most effective treatment for these complications. Therefore, the aim of our clinical trial was to compare the use of polidocanol foam sclerotherapy with compression therapy to wound drainage, in the treatment of post-operative lymphoceles. PATIENTS AND METHODS: Retrospectively we analysed the data of 33 consecutive surgical patients who had developed a post-operative lymphocele between 2004 and 2008. We offered all patients drainage with compression therapy or polidocanol foam sclerotherapy with 1-day compression to treat the post-operative lymphoceles. RESULTS: Altogether, 12 patients were treated with polidocanol foam sclerotherapy and 21 patients were treated with drainage alone. Secretion volumes declined from initial 50-350 ml/day to 0-20 ml/day at the end of the therapy. Lymphorrhea resolved much quicker (P < 0.0001) in patients treated with polidocanol foam sclerotherapy (median 4 days, mean value 6.4 days) than in those treated with drainage (median 31 days, mean value 30.2 days). None of the patients developed a major complication. CONCLUSION: Polidocanol foam sclerotherapy is an effective and well-tolerated new treatment for patients with post-operative lymphoceles.

Foam and liquid sclerotherapy for varicose veins.

OBJECTIVE: The objective of this study is to review the methods and outcome of ultrasound-guided foam sclerotherapy (UGFS) for the treatment of superficial venous incompetence. METHOD: Medical literature databases including Medline were searched for recent literature concerning UGFS. Papers describing methods and outcome have been assessed and their main findings included in this summary. A detailed description of the methods used by the author has been included as an example of how successful the treatment may be achieved. RESULTS: A diverse range of practice is described in published literature in this field. Each group of authors used their own variation of the methods, described in the published literature, with good results. It is clear that foam sclerotherapy is far more effective than liquid sclerotherapy and that ultrasound imaging allows the treatment to be delivered accurately to affected veins. There is evidence that 3% policocanol foam is no more effective than 1% polidocanol foam. The optimum ratio of gas to liquid is 4:1, although a range of ratios is reported in published work. There is a wide variation in the volume used as well as the method by which it is injected. The use of carbon dioxide foam reduces the systemic complications, particularly visual disturbance, when compared with air foams. Very few serious adverse events have been reported in the literature despite the widespread use of this method. Rates of recanalization of saphenous trunks following UGFS are similar to those observed after endovenous laser and endovenous radiofrequency ablation of veins, as well as the residual incompetence after surgical treatment. CONCLUSIONS: UGFS is a safe and effective method of treating varicose veins. The relative advantages or disadvantages of this treatment in the longer term are yet to be published.

Treating malignant pleural effusions cost consciously.

Malignant pleural effusions are associated with significant morbidity. Prompt clinical evaluation followed by aggressive treatment often results in successful palliation. This report summarizes the traditional and experimental approaches used in the management of malignant pleural effusion and provides an attempt at analysis of cost comparison and resource utilization associated with the use of various sclerosing agents. The standard sclerotherapy for malignant pleural effusions has routinely been performed as an inpatient procedure using a large-bore chest tube for drainage and instillation of a sclerosing agent. Use of a small-bore catheter for drainage and pleurodesis is associated with reduced patient discomfort and appears to be feasible and equally efficacious in the ambulatory setting. Results with the ambulatory procedure are preliminary but promising. Future comparisons with the traditional approach will allow therapy to be based not only on efficacy, but also on the use and expense of related resources.

[Endoscopic hemostasis in bleeding gastroduodenal ulcer--a contribution to the cost aspect]. / Endoskopische Blutstillung bei der gastroduodenalen Ulkusblutung--Ein Beitrag zur Kostenproblematik.

Endoscopic injections of fibrin glue for the treatment of gastroduodenal ulcer hemorrhage have been increasingly used instead of sclerosing agents since 1987. Sclerosants have the drawback that they themselves have tissue-destroying or rather ulcerogenic effects. A difficult form of administration and a relatively high price are set against the good biological properties of the fibrin glue. In a randomized study comparing fibrin glue with polidocanol there was a statistically significant lower rebleeding rate in the fibrin group. The data of this study were analysed with regard to economic aspects. They showed an improved cost-benefit and cost-effectiveness ratio of the fibrin glue compared with polidocanol.