Neoplasms

Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Cysts

Ovarian Cysts

Pathological Conditions, Anatomical

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Anti-Infective Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Tetracycline

Polidocanol

Sclerosing Solutions

injection of sclerosing agent (tetracycline or polidocanol) into ovarian cyst after aspiration of its contents

sclerotherapy

Khaled Abdallah

The aim of this study was to evaluate the role of sclerotherapy (injection of tetracycline or injection of Polidocanol - 95% hydroxypolyethoxydodecane and 5% ethanol -) in treatment of non-neoplastic ovarian cysts by, percutaneous trans-abdominal approach or trans-vaginal approach.

Ovarian cysts are fluid-filled sacs that form in or on an ovary. Such cysts are relatively common. Most are non-cancerous (benign) and disappear on their own. Ovarian cancer is more likely to occur in women over 50.

Most of the patients with ovarian cyst are symptomless and resolves spontaneously. If untreated, complications such as rupture, torsion, malignant transformation may occur.

Cyst rupture can lead to peritoneal signs, abdominal distension and bleeding, irregularity of the menstrual cycle and abnormal vaginal bleeding, dull bilateral pelvic pain may result from the lutein cysts.

Until recent times, surgery in the form of laparotomy or laparoscopy has been the first choice. However, ultrasonography guided aspiration of the cysts as an alternative treatment is the fast catching up and may even be procedure of choice in the management of ovarian cysts in a selected group of women as it has low recurrence rate, low risk, less cost and in most cases no hospital stay.

There are various types of ovarian cysts, such as functional cysts, follicular cysts, corpus luteum cysts, hemorrhagic cysts, theca-lutein cysts, peritoneal inclusion cysts or pseudo-cysts, polycystic ovaries and endometriomas.

Functional cysts do not regress when treated with combined oral contraceptives that they do with expectant management.

Ovarian cysts are common, affecting 20% of women at some point in their lives . Unlike unilocular cysts including septations, solid irregular wall, or internal plaques, the simple ovarian cyst is defined as an anechoic round or oval lesion. The maximum diameter of simple ovarian cysts in premenopausal women is less than 5 cm, they often disappear during the menstrual cycle and do not require further intervention. Larger cysts (5-7 cm) should be followed using ultrasonography. Cysts larger than 7 cm may require advanced imaging or surgery.

Differential diagnosis in the management of an adnexal mass is complex because of the scope of the disorders that may have caused it and the numerous therapies that may be appropriate. It is the risk of malignancy that propels protocols and procedures, as well as the fundamental concept that early diagnosis and treatment in cancer are related to lesser mortality and morbidity. Non neoplastic ovarian cysts in women with menstrual cycles are the most frequently detected masses involving the adnexa. Many of these cysts are functional and resolve spontaneously within a few days to 2 weeks, but they can persist longer.

The management of women with benign ovarian cysts remains controversial. Various treatment protocols use medical treatment (mainly oral contraceptives), ultrasound-guided aspiration, laparoscopy (cystectomy or drainage and ablation of the cystic wall) and laparotomy (cystectomy) Sclerotherapy of ovarian cysts has been attempted to decrease the probability of recurrence. Although ultrasound-guided aspiration is simple and safe, the recurrence rate is high, ranging from 28.5% to 100%. In order to reduce this rate, ultrasound-guided ethanol sclerotherapy for ovarian cysts was first introduced in 1988, and it has been reported by several authors to be simple and safe.

Tetracycline, methotrexate, and ethanol are the most common agents used for sclerotherapy. When compared to women without cysts, sclerotherapy applied to infertile women with ovarian cysts has been shown to reduce pelvic pain without affecting the number of follicles, term pregnancy and abortion rates, the number of obtained oocytes, embryo quality, or hormonal levels.

We chose either tetracycline or Polidocanol as sclerosing agents. Tetracycline because of its antibacterial effect, which may help to control infections. Tetracyclines (tetracycline, doxycycline, minocycline) have been used as sclerosing agent in various clinical settings such as pleural effusions, pneumothoraxes, hydroceles, benign lymphoepithelial cysts of the parotid gland and lymphoceles after renal transplantation.

Polidocanol is a nonionic surfactant sclerosing agent, which consists of 95% hydroxypolyethoxydodecane and 5% ethanol. Polidocanol was invented as an anesthetic agent. Polidocanol is a liquid surfactant having endothelial cell lytic properties.

The mechanism underlying the sclerosing effect was generally attributed to the results of local chemical irritation or inflammatory response. Ethanol induces a combination of cytotoxic damage, dehydration of cells, and production of mediators for inflammation and fibrosis.

Role of Sclerotherapy in Treatment of Non-neoplastic Ovarian Cyst

The main outcome measure was the disappearance of the cyst and the avoidance of surgery. The cyst was considered resolved if follow-up revealed either no cystic lesion or only a follicle-like cyst no more than 30 mm in diameter.

Al-Azhar University

Resident Doctor

Diseases and Abnormalities at or Before Birth

Blood and Lymph Conditions

Rare Diseases

Congenital Abnormalities

Lymphangioma

Lymphatic Abnormalities

Neoplasms by Histologic Type

Lymphatic Diseases

Lymphatic Malformations

Antineoplastic Agents

Bleomycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

In this arm, patients with lymphatic malformations were treated by intracapsular injection with low-dose concentrations (1mg/ml) of Bleomycin.

In this arm, patients with lymphatic malformations were treated by intracapsular injection with high-dose concentrations (2mg/ml) of Bleomycin.

To validated the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of lymphatic malformations for pediatric patients

Yi Ji, Ph.D.

Min Yang, M.D.

Bleomycin has nowadays been more and more widely used in the sclerotherapy of LMs, which has been proven to be primarily dose dependent. The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients.

Lymphatic malformations (LMs) are vascular anomalies that arise from abnormal embryonic development of the lymphatic system and might present as dilated lymphatic channels or cysts lined by lymphatic endothelial cells. With an estimated incidence of approximately 1/4000-1/2000, LMs can occur at any site in the lymphatic system, in which head, neck and axilla were mostly detected and have been reported to account for over 75%. Based on the location and size of the lesion and the extent of involvement, LMs may be asymptomatic with incidental detection, or chronic abdominal pain and distension due to their compression of surrounding structures, or critical and even fatal secondary to their volvulus, hemorrhage, infection and rupture. Surgical excision is a definitive treatment for LMs, while it may be difficult at times because of the infiltrative nature of the lesions, leading to a high incidence of complications like vital organ injuries, nerve injuries, bleeding, infection scar formation, and recurrences. Sclerotherapy is a simpler alternative to tedious surgical excision treatment for LMs and avoids the complications related to surgery. As an anticancer drug extracted from Streptomyces verticillus, Bleomycin has been more and more widely used in the sclerotherapy of LMs for pediatric patients, which has been proven to be primarily dose dependent. However, the optimum concentration of Bleomycin in the sclerotherapy of LMs for pediatric patients has not been strictly validated, due to the lack of high-quality RCT studies. The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients.

The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of lymphatic malformations for pediatric patients.

Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients

Efficacy and Safety of Different Concentrations of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients

Changes of Volume is defined as follows: a complete (90%-100% reduction in LMs volume), substantial (60%-89% reduction in LMs volume), intermediate (20%-59% reduction in LMs volume), or no (\< 20% reduction in LMs volume) response 3 to 6 months post-therapy as assessed by imaging.

Score of Pain is selfassessed at each visit on a 0 to 10 visual analog scale (where 0 indicates no pain and 10 indicates the worst pain imaginable), reported along with period duration.

Global efficacy is assessed at each visit beginning at MS by the physician and self-assessed by the participant and proxy (parents) on a 0 to 10 visual analog scale (where 0 indicates no efficacy and 10 indicates complete resolution).

Score of Quality of Life is assessed by the validated Children-Dermatological Life Quality Index (C-DLQI).

Number of Participants with Efficacy was assessed by 2 independent experts.

Number of Participants with Safety was assessed based on physical signs and monitoring of imaging examinations or laboratory test.

West China Hospital

Clinical Professor

Lymphocele

Patients with symptomatic lymphocele who are managed with percutaneous drainage and sclerotherapy.

Patients with symptomatic lymphocele who are managed with percutaneous drainage alone.

Lymphocele percutaneous / transvaginal drainage with a use of a vascular catheter followed by sclerotherapy.

Drainage and sclerotherapy.

Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy).

Drainage alone.

Maciej Stukan

Maciej Stukan, MD

Symptomatic lymphocele (LC) can be a complication after pelvic and para-aortic lymphadenectomy performed for treatment or staging purposes in the management of some cancers. Management procedures are: single or repeated puncture, prolonged drainage with drains or catheters, mostly followed by sclerotherapy, or surgery. A decision, which management option is most optimal, should be guided by two principles: first to control patient's symptoms, second to apply the least invasive but effective way to treat LC, taking into account that the patient has undergone major surgery recently, and often needs adjuvant treatment at the moment when symptomatic LC is diagnosed.

The aim of this study is to validate feasibility, safety and efficacy of a minimally invasive management of a symptomatic LC - drainage with the usage of vascular catheter followed by sclerotherapy, as well as to evaluate patient's experience on the treatment.

Patients with symptomatic LC are evaluated with ultrasound. Data about diameters, estimated volume of LC and other organs failure if appear is recorded. Management options are discussed with patient, and if the method with catheter insertion and drainage is chosen than the patient is eligible for the study. After vascular catheter insertion into LC and fluid evacuation, patient is followed with active drainage. Patients with drainage only are observed for a short period of time (up to 7 days), and if not efficient a sclerotherapy is considered. In case a patient does not agree to sclerotherapy, or there are contraindications, or it is doctor's decision that drainage alone is sufficient, than the prolonged drainage without sclerotherapy is the only procedure. The choice about the regimen used for sclerotherapy, it's volume, time intervals between repeated infusion depend on institution practice.

Data concerning feasibility, safety and efficacy are noted in designated templates. Patients' experience on the treatment is evaluated with formal questionnaire FACIT-TS-G.

The study is observational. Primary outcome measure is to establish efficacy of the method. Secondary outcome measures are safety and patient's experience on the treatment.

Investigators hope to establish step-by-step guidelines for optimal, minimally invasive management of symptomatic lymphocele.

Management of Symptomatic Post-operative Lymphocele

Management of Symptomatic Post-operative Lymphocele With an Patient-controlled, Vascular Catheter: A Validation Study

measured with a questionnaire FACIT-TS-G (Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General) available from http://www.facit.org/facitorg/questionnaires. Permission to use obtained.

Successful lymphocele treatment means complete resolution of lymphocele after minimally invasive procedures - percutaneous drainage with a vascular catheter followed by sclerotherapy or drainage alone. Opposite - non successful treatment defined when the patient is refered for a surgical management.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Role of Sclerotherapy in Treatment of Non-neoplastic Ovarian Cyst	NCT06399744	Benign Ovarian ...	sclerotherapy	15 Years - 48 Years	Al-Azhar University
Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients	NCT06437158	Lymphatic Malfo...	Bleomycin	- 14 Years	West China Hospital
Management of Symptomatic Post-operative Lymphocele	NCT02800980	Lymphocele	Drainage and sc... Drainage alone.	18 Years -	Gdynia Oncology Center
Management of Symptomatic Post-operative Lymphocele	NCT02800980	Lymphocele	Drainage and sc... Drainage alone.	18 Years -	Gdynia Oncology Center
Role of Sclerotherapy in Treatment of Non-neoplastic Ovarian Cyst	NCT06399744	Benign Ovarian ...	sclerotherapy	15 Years - 48 Years	Al-Azhar University

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