View clinical trials related to Esophageal Fistula.
Filter by:This pilot, prospective, interventional, monocentric, independent, and no-profit clinical trial aims to investigate and evaluate the proportion, acute and chronic characteristics, and outcomes of esophageal thermal injury (ETI) in AF ablation using a high-power, short-duration (HP-SD) setting with contact force (CF) sensing tip ablation catheter in standard clinical practice. The main questions it aims to answer are: - Evaluate the acute proportion of the ETI assessed by the mini-invasive esophagoscopy pre and post-procedure. In addition, clinical evaluations at 3, 6, and 12 months from the procedure are foreseen. - Evaluate the contribution of the factors influencing RF procedure (contact force, impedance, RF power, RF time) on ETI development. - Describe the relationship between the esophageal temperature (continuous monitoring) and ETI development.
Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the oesophagus caused by thermal energy being transmitted to the oesophagus from the heart. The oesophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe oesophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result. In a recent study, it was shown that a more advanced type of oesophageal probe that cools the oesophagus during ablation is better at protecting the oesophagus from ablation-related injury compared to the standard care probe currently used. As it was a single-centre study, more evidence is required before knowing if this type of probe is more effective in protecting the oesophagus. The purpose is to run a multi-centre randomized study to compare the safety of AF ablation when there is protection by the oesophageal cooling probe versus the standard of care oesophageal temperature monitoring probe. This means that there is a 50:50 chance of the new cooling probe being used during AF ablation for participants.
The study aim at comparing outcomes from the implementation of various endoscopic closure techniques including stenting and suturing on the healing and resolution of esophageal wall defects.
How does oesophageal atresia/trache-oesophageal fistula affect feeding and swallowing in the first year of life? Approximately 150 babies a year are born with oesophageal atresia and/or trache-oesophageal atresia. Oesophageal atresia occurs when the oesophagus (food pipe) fails to join up during early foetal development. Trache-oesophageal fistula describes an abnormal connection that forms between the oesophagus and trachea (wind pipe). When the baby feeds, milk cannot pass into the stomach but can pass into the lungs. Surgery is needed within the first few days of life and is extremely successful, with 90-95% of babies surviving. However, approximately 50-80% of babies will have ongoing feeding or swallowing difficulties resulting in choking, chest infections and pneumonia. They can also lead to food refusal, distress at mealtimes and parental anxiety. Currently there is limited understanding of: - the exact nature of the feeding and swallowing difficulties - the risk factors for developing difficulties - the impact on parents. This study will address these issues through two complimentary projects: Project 1: A study of swallow physiology Babies with oesophageal atresia and/or trache-oesophageal fistula who have surgery at Great Ormond Street Hospital will be invited to have a detailed swallow assessment using videofluoroscopy (video x-ray) and high resolution impedance manometry (a pressure monitor) at 2-4 months of age and at 8-12 months of age. Results will be compared to parent report of feeding at 1 year old. Project 2: A study of the impact on parental well-being This study will be carried out in conjunction with the 'TOFS' support group. A Facebook page will be used to carry out an online forum. Parents of any child who has had TOF/OA will be invited to share their experiences of establishing feeding. This information will be used to develop a questionnaire to look at how wide-ranging these experiences are.
Catheter ablation of atrial fibrillation with electrical isolation of the pulmonary veins in the left atrium carries risk of esophagus thermal lesion. EnsoETM is a device . This study evaluates the benefit of using the EnsoETM, a device device for esophageal temperature adjustments, during catheter ablation of atrial fibrillation. Half of participants will undergo esophageal temperature adjustment during pulmonary vein catheter ablation, while the other half will undergo catheter ablation with no esophageal temperature adjustment.
Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects. The investigators want to use also TCA 50% for endoscopic repair in children with recurrent TEF.