Infections

All Conditions

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Digestive System Diseases

Rare Diseases

Communicable Diseases

Papilloma

Acquired Immunodeficiency Syndrome

HIV Infections

Virus Diseases

HIV Seropositivity

Anus Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Anal Cancer

Argon Plasma Coagulation (APC) is a non-contact electrosurgical technique delivering a high-frequency electrical current through ionized argon gas i.e. the argon plasma. This current produces a zone of coagulation, desiccation, and devitalisation 2-3 mm deep. Patients will be offered up to 3 treatments if recurrence occur after the first two.

Argon Plasma Coagulation

Alexandra de Pokomandy, MD

George Ghattas, MD

The purpose of this study is to assess if argon plasma coagulation (APC) is a safe and well tolerated treatment method for anal intraepithelial neoplasia (AIN) grade 2/3 in HIV-positive men having sex with men (MSM).

HIV infected men having sex with men (MSM) are at increased risk of developing anal cancer compared to the general population and the incidence continues to increase despite better control of HIV infection with HAART (Highly Active Anti-Retroviral Therapy). The causative agent is known to be Human Papilloma Virus infection which can lead to dysplastic changes in the anus, detectable by High Resolution Anoscopy with biopsies. The analysis of the abnormal tissue can then be graded as Anal Intraepithelial Neoplasia 1 to 3, with AIN 2 or 3 considered as high grade dysplasia. These lesions are cancer precursors, but the proportion of lesions progressing to invasive anal cancer and the time to event are unknown. There is currently no recognized treatment to offer as standard of care although it is of general belief that treating these lesions, as it is done for women with CIN 2 and 3 (Cervical Intraepithelial Neoplasia) could help decrease the number of progressions to invasive anal cancer in MSM infected with HIV.

By experience at our center and results of this technique for other gastrointestinal pathologies, we believe Argon Plasma Coagulation (APC) could be a safe, well tolerated and efficient treatment of high-grade dysplasia (AIN 2/3) in HIV infected MSM.

This study will assess the APC treatment in 20 patients, all HIV infected MSM, with established AIN 2/3 (as confirmed with their last two anal biopsies, at least 4 months apart). Patients will then be followed with regular High Resolution Anoscopies for two years. The primary objective is to assess if APC is a safe and well tolerated treatment method for AIN 2/3 in HIV-positive MSM. As secondary objectives, the efficacy of APC treatment on AIN 2/3 lesions in HIV-positive MSM, the number of treatments with APC necessary to obtain regression or resolution of AIN 2/3 over two years and the efficacy of APC treatment to decrease anal HPV in this population will also be addressed.

Tolerability, Safety, & Efficacy of Argon Plasma Coagulation to Treat Anal Intraepithelial Neoplasia in HIV-Positive Men

A Phase II, Prospective, Open-label, Pilot Study of the Tolerability, Safety, and Efficacy of Argon Plasma Coagulation for the Treatment of Anal Intraepithelial Neoplasia Grade 2 or 3 in HIV-positive Men Having Sex With Men

McGill University Health Centre/Research Institute of the McGill University Health Centre

CIHR Canadian HIV Trials Network

Centre hospitalier de l'Université de Montréal (CHUM)

Respiratory Tract (Lung and Bronchial) Diseases

Constriction, Pathologic

Airway Obstruction

Respiratory Insufficiency

Respiration Disorders

Respiratory Tract Diseases

give the cases whose central airway stricture were caused by soft neoplasm tissues cryotherapy

give the cases whose central airway stricture were caused by hard neoplasm tissues argon plasma coagulation

give the cases whose central airway stricture were caused by neoplasm compression stent placement

give the cases whose central airway stricture were caused by polypoid neoplasm tissues snare

use cryotherapy to delete soft neoplasm tissue in the airway

cryotherapy

use argon plasma coagulation to delete hard neoplasm tissue in the airway

argon plasma coagulation

use stent placement to open the airway compressed by out neoplasm

stent placement

use snare to delete polypoid neoplasm tissue in the airway

deletion tumor tissue by snare

Deguang Mu, Ph.D

Yandong Nan, MD

Faguang Jin, Ph.D

The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of malignant central airway stricture.

The four techniques are：

* cryotherapy
* argon plasma coagulation
* stent
* snare

Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Prospective, Open, Multicenter Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Changhai Hospital

The First Affiliated Hospital of Guangzhou Medical University

Xinqiao Hospital of Chongqing

China Meitan General Hospital

Micro-Tech (Nanjing) Co., Ltd.

Tang-Du Hospital

Lung Neoplasms

Hemoptysis

Lung Diseases

Hemorrhage

Signs and Symptoms, Respiratory

Coagulants

All Drugs and Chemicals

Hemostatics

Hemoptysis patients caused by endobronchial malignancies

Patients will be treated with Argon Plasma Coagulation. Argon plasma coagulation (APC) is a form of non contact electrocoagulation. APC utilizes electrically conductive argon plasma as a medium to deliver high-frequency current via a flexible probe. The argon plasma flow transfers electricity between the probe and the target tissue. Tracheobronchial access is obtained by passing the probe through the working channel of the bronchoscope. On arrival to the tissue, the application of energy causes uniform zones of desiccation, coagulation and devitalization in the areas receiving treatment, thus inducing hemostasis.

Michele Mondoni, MD

The aim of this study is to evaluate the efficacy, the safety and the main predictors of success of bronchoscopic Argon Plasma Coagulation in patients with hemoptysis caused by endobronchial malignancies.

Hemoptysis is a challenging symptom which may be frequently related to endobronchial malignancies. Patients with central neoplasms and hemoptysis show a lower median survival than patients with no bleeding and endobronchial neoplasms and/or patients with hemoptysis and peripheral malignant lesions.

Hemoptysis control without recurrence at 48 hours after bronchoscopic interventions may improve survival in patients with mild bleeding and endobronchial malignancies.

Argon Plasma Coagulation is considered one of the most effective techniques for endobronchial management of hemoptysis in this subset of patients. Nevertheless, few data are available in literature on its efficacy and safety, and the main predictors of success are still unclear.

In this prospective, observational study, investigators aim to evaluate the efficacy (i.e. immediate bleeding cessation without recurrence during the following 48 hours) of endoscopic Argon Plasma Coagulation in patients with hemoptysis caused by endobronchial neoplasms.

Investigators will also evaluate the safety of the procedure, the main variables associated to a successful intervention, the presence of hemoptysis relapses and patients overall survival to 3,5 months after the bronchoscopic intervention.

Efficacy and Safety of Argon Plasma Coagulation in the Treatment of Patients With Hemoptysis Caused by Endobronchial Malignancies

Prospective, Observational Study on the Efficacy, the Safety and the Predictors of Success of Argon Plasma Coagulation in the Treatment of Patients With Hemoptysis Caused by Endobronchial Malignancies

Percentage of patients with bleeding cessation without recurrence at 48 hours after bronchoscopic Argon Plasma Coagulation employed to stop hemoptysis caused by endobronchial malignancies

Incidence of adverse events following bronchoscopic Argon Plasma Coagulation in the treatment of patients with hemoptysis and endobronchial malignancies

Incidence of hemoptysis recurrences (number of relapses)

Number of patients with hemoptysis and endobronchial malignancies who are still alive after 3,5 months after the endoscopic intervention

Clinical and endoscopic factors (composite measure) associated to bleeding cessation after the intervention (i.e. age, gender, ethnicity, smoking history, cancer type and stage, ECOG performance Status, concomitant heart, lung, kidney and liver disease, antiplatelet/anticoagulant therapy, creatinine and hemoglobin level and platelet count, PT and PTT values; endoscopic location of malignancy (i.e. lobe and side), endoscopic growth pattern of malignancy (i.e. exophytic, submucosal/peribronchial growth), current/former chemotherapy and radiation therapy on the chest, time from malignancy diagnosis to hemoptysis onset, time from hemoptysis onset to endoscopic treatment, necessity of blood transfusion).

University of Milan

Principal investigator

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Dermatologic Agents

Antineoplastic Agents

Photosensitizing Agents

Dihematoporphyrin Ether

Trioxsalen

Hematoporphyrin Derivative

Photodynamic therapy (PDT) uses activation of a photosensitizer by light of a specific wavelength to generate reactive oxygen species and singlet oxygen that causes direct cell damage and death, apoptosis, tumor vasculature damage and thrombosis, and inflammation leading to an immunological response.Following randomization, subjects will undergo treatment with either PDT or APC. Subjects will then have six additional study visits at 30, 45, 60, 90, and 180 days after their last PDT or APC treatment

Argon plasma coagulation (APC) is a noncontact form of electrocautery. Following randomization, subjects will undergo treatment with either DPT or APC. Subjects will then have six additional study visits at 30, 45, 60, 90, and 180 days after their last PDT or APC treatment.

Participants on this arm will be treated with photodynamic therapy. PDT is a two-stage process. The first stage of PDT is the intravenous injection of porfimer sodium (Photofrin) administered as a single slow intravenous injection over 3 to 5 minutes. The second stage involves the application of laser light to the tumor by bronchoscopy.

Photodynamic Therapy

Participants on this arm will be treated with argon plasma coagulation. A flexible probe housing a wire delivers high-frequency, high-voltage electric current to a monopolar tungsten electrode present at the tip of the probe. Argon gas flows through the probe, and is charged or ionized to produce "plasma" as it flows around the tungsten electrode. Electric current flows through the plasma to the nearest tissue, and heat is produced as it passes through the tissue. Increased resistance created by coagulated tissue impairs the flow of electric current, and keeps the ablation depth to 1 to 2 mm.

Michael Jantz, MD

The purpose of the study is to assess the efficacy of photodynamic therapy (PDT) in relieving airway obstruction in subjects with lung cancer compared to treatment with argon plasma coagulation (APC).

This is a multi-center, randomized study that will compare the efficacy of photodynamic therapy (PDT) and argon plasma coagulation (APC) in the treatment of airway obstruction caused by non small cell lung cancer. Participants will be randomized in a 1:1 ratio to receive treatment with one of these two treatment modalities.

Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction

Multi-Center, Randomized Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction

Measure the time until treatment failure. Treatment failure is defined in this study as the occurrence of any of the following: failure to improve airway patency, airway-re-obstruction, need for additional airway intervention, and/or worsening symptoms at 90 days after the last PDT or APC treatment .

QLQ-LC13 incorporates one multi-item scale to assess dyspnoea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and haemoptysis. All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems.

This will be assessed as Yes/No at each of the time points as to whether additional bronchoscopic therapies are needed, in the opinion of the treating investigator

The median survival time for each treatment cohort will be estimated in days after the last PDT or APC treatment using a Kaplan-Meier survival curve

Percent reduction in airway obstruction will be calculated with the formula: \[(baseline obstruction percentage - residual obstruction percentage)/baseline obstruction percentage x 100%\].

This will be assessed by examining subject chest x-rays and/or chest CT scans at each of these time points for the presence or absence of atelectasis.

This will be assessed by examining subject chest x-rays and/or chest CT scan for the presence or absence of post-obstructive pneumonia, as well as the physical examination of subjects for post-obstructive pneumonia symptoms (such as fever, pleuritic chest pain, and productive cough) at each of these time points.

The Baseline Dyspnea Index measures the severity of dyspnea at baseline using the sum of the scores for three items that assess functional impairment and magnitude of effort required for daily activities. Total possible score ranges from 0 to 12. A lower total score indicates more severe dyspnea. The Transitional Dyspnea Index evaluates change in dyspnea as compared to the score obtained by the Baseline Dyspnea Index using a scale of -9 to +9. A negative score (-1 to -9) indicates worsening dyspnea as compared to baseline, a positive score (+1 to +9) indicates improvement in dyspnea as compared to baseline, and a score of 0 indicates no change in dyspnea as compared to baseline.

Treatment failure is defined as failure to improve airway patency, airway re-obstruction, need for additional airway intervention and/or worsening symptoms.

Concordia Laboratories Inc.

University of Florida

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Breast surgery is performed using regular electric scalpel

Breast surgery is performed using argon plasma coagulation scalpel

On the first group we use the regular electric scalpel to perform the surgery , and on the second group we use the argon plasma coagulation scalpel to perform the procedure.

The investigators are selecting sixty (60) with breast cancer diagnoses where the surgical treatment is indicated.Furthermore the investigators divided in two groups : 1) surgical treatment using regular electric scalpel ; 2) surgical treatment using argon plasma coagulation scalpel. Our primary goal is to measure the bleeding during the surgery using the weight of the surgical tissues used. Secondary we'll evaluate the immediate post operative outcomes, like infection, hematomas and seromas. All these variables will be evaluated by a doctor using our standard clinical record and it will be measured using reliable parameters, for exemple: if the investigators clinically detect a hematoma then we'll perform an ultrasound to take the real extension; if the investigators clinically pick an infection we'll measure the extension of the hiperemia; and if the investigators clinically pick a seroma we'll drain and quantify it. Secondary the investigators going to evaluate and measure (centimeters) the terminal damage caused on the surgical specimens (samples) using the microscope.

Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer

evaluate the bleeding during the surgery using weight of the surgical tissues used during the procedure.

evaluate the occurrence of hematomas, seromas and infection using our clinical record as standard evaluation and measure it when it's possible ( like explained on the brief comments.

evaluate the thermal damage on the surgical peace margins produced with both scalpels.

Federal University of São Paulo

Doctor

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Agents

Omeprazole

Proton Pump Inhibitors

Antacids

Anti-Ulcer Agents

Enzyme Inhibitors

treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d)

treatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

Argon Plasma Coagulation 90W power

Argon Plasma Coagulation 60W power

Omeprazole 120 mg

Omeprazole 40 mg

Background and study aims. To evaluate the impact of power setting and proton pump inhibitor (PPI) dose on the efficacy and safety of argon plasma coagulation (APC) of Barrett's esophagus (BE) with low-grade dysplasia (LGD).

Patients and methods. Investigator initiated, single-center, parallel-group randomized controlled trial (RCT) conducted in a tertiary referral center in Poland. Consecutive patients with BE and LGD were randomly assigned to APC with power set at 90 Watt (90W) or 60 Watt (60W) followed by 120 mg or 40 mg omeprazole for six weeks. The primary outcome of the study was the rate of complete (endoscopic and histologic) ablation of BE at six weeks. Secondary outcomes included safety and long-term efficacy (at two years and at the end of a long-term follow-up of over 4 years.

Investigator initiated, single-center, parallel-group RCT conducted in a tertiary referral center in Poland.

Patients were blinded to the power settings used for APC, but they knew the PPI dose they received. The endoscopist performing APC ablation was blinded to participant allocation and APC power setting (the power was set up by an assistant who knew the group allocation and the power display remained covered during the entire procedure). The endoscopist and pathologist involved in efficacy assessment were blinded to participant allocation.

Argon Plasma Coagulation for Barrett's Esophagus

Argon Plasma Coagulation for Barrett's Esophagus With Low Grade Dysplasia: A Randomized Trial With Long Term Follow-up Evaluating the Impact of Power Setting and Proton Pump Inhibitor Dose

Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tolerability, Safety, & Efficacy of Argon Plasma Coagulation to Treat Anal Intraepithelial Neoplasia in HIV-Positive Men	NCT00428285	Anus Neoplasms HIV Infections	Argon Plasma Co...	18 Years - 65 Years	Centre hospitalier de l'Université de Montréal (CHUM)
Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture	NCT02299830	Airway Obstruct...	cryotherapy argon plasma co... stent placement deletion tumor ...	18 Years - 70 Years	Tang-Du Hospital
Efficacy and Safety of Argon Plasma Coagulation in the Treatment of Patients With Hemoptysis Caused by Endobronchial Malignancies	NCT03625947	Hemoptysis Cancer	Argon Plasma Co...	18 Years -	University of Milan
Trial of Photodynamic Therapy Versus Argon Plasma Coagulation for Lung Cancer With Endobronchial Obstruction	NCT03564054	Non Small Cell ...	Photodynamic Th... Argon Plasma Co...	18 Years - 99 Years	University of Florida
Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer	NCT02548338	Breast Neoplasm...	argon plasma co...	18 Years - 85 Years	Federal University of São Paulo
Argon Plasma Coagulation Scalpel on Surgical Treatment of Breast Cancer	NCT02548338	Breast Neoplasm...	argon plasma co...	18 Years - 85 Years	Federal University of São Paulo
Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture	NCT02299830	Airway Obstruct...	cryotherapy argon plasma co... stent placement deletion tumor ...	18 Years - 70 Years	Tang-Du Hospital
Argon Plasma Coagulation for Barrett's Esophagus	NCT04154748	Barretts Esopha...	Argon Plasma Co... Argon Plasma Co... Omeprazole 120 ... Omeprazole 40 m...	18 Years -	Maria Sklodowska-Curie National Research Institute of Oncology

Spots Global Cancer Trial Database for argon plasma coagulation