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Esophageal Achalasia clinical trials

View clinical trials related to Esophageal Achalasia.

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NCT ID: NCT06271395 Recruiting - Clinical trials for Cricopharyngeal Achalasia

Ultrasound-guided Botulinum Toxin Injection on Cricopharyngeal Muscle Dysfunction

Start date: February 28, 2024
Phase: N/A
Study type: Interventional

Ultrasound-guided injection is a visual, convenient, and radiation-free technique that allows real-time observation of the needle insertion process and drug injection location. The combination with a balloon for fixation further enhances the precision of the injection. In this study, we employed ultrasound-guided injection combined with balloon localization for cricopharyngeal muscle botulinum toxin injection treatment and conducted clinical observations.

NCT ID: NCT06264466 Recruiting - Clinical trials for Esophageal Achalasia

Safety and Efficacy of a Novel Flexible Bipolar in POEM

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

Per-oral endoscopic myotomy (POEM) is a minimally invasive therapy for achalasia. The procedure has demonstrated high technical and clinical success with lower adverse events. Different types of knives have been used for cutting and coagulation during the procedure; however, exchanging accessories is sometimes needed to perform all the stages of POEM. To overcome this disadvantage, the investigators aim to evaluate a single device that integrates in its tip bipolar radiofrequency and microwave, the Speedboat Ultraslim (Creo Medical, UK) for cutting and coagulation during POEM procedure. Some of the promise's advantages derived from its use are: (1) less inflammation, (2) clear differentiation between layers, (3) the use of a single device for the procedure. This single-center, prospective, interventional study will include patients with achalasia submitted to POEM procedure, with or without fundoplication (POEM-F). All stages (mucosal incision, submucosal tunneling, myotomy) of POEM will be performed using the Speedboat ultraslim flexible catheter. Technical and clinical success, along with safety will be the primary endpoints; while, post-procedure reflux symptoms and quality of life will be assessed as secondary outcomes with reflux severity index (RSI) and the Northwestern Esophageal Quality of Life (NEQOL), respectively.

NCT ID: NCT06213662 Recruiting - Dysphagia Clinical Trials

Effect of Botulinum Toxin Injection Guided by Ultrasound Combined With Balloon Localization on Cricopharyngeal Achalasia

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

cricopharyngeal achalasia refers to incomplete or non-open functional opening of the cricopharyngeal muscle, and after repeated swallowing of food, it still cannot pass through the cricopharyngeal muscle, remaining in the epiglottic valley and the piriform fossa, and even regurgitated into the nasal cavity . Neurogenic diseases, myogenic diseases and head and neck tumors are the common causes. Patients with chronic underfeeding lead to malnutrition, reduced quality of life, affecting the outcome of the disease. At present, the treatment measures for cricopharyngeal achalasia at home and abroad include balloon dilation technique, surgical incision, botulinum toxin injection. The dilation of the balloon is easy to cause mucosal edema and damage. Local infection, massive hemorrhage, local nerve injury and other complications often occur in cricopharyngotomy. Botulinum toxin injection relieves muscle spasms and is now widely used to treat dystonia. Common injection localization methods include CT, ultrasound, electromyography and endoscopy. Ultrasound-guided injection is a new technique of visualization, simple and non-radiation injection guidance, which can observe the injection process and drug injection position in real time. Fixation with a balloon can further improve the accuracy of the injection. In this study, botulinum toxin was injected into the cricopharyngeal muscle by ultrasound combined with balloon.

NCT ID: NCT06189859 Recruiting - Achalasia Clinical Trials

Electrosurgical Modes for Endoscopic Submucosal Dissection in Peroral Endoscopic Esophageal Myotomy

Start date: March 16, 2024
Phase: Phase 3
Study type: Interventional

Peroral endoscopic esophagel myotomy (POEM) is a third space endoscopy technique that depends on creating a submucosal tunnel to expose the esophageal muscle and eventually perform an esophageal myotomy. Submucosal dissection can be performed using numerous electrosurgical modes. Spray coagulation has been anecdotally favored by many endoscopists due to its high coagulation power and assumed safety. Recently, Precisect mode has been developed, it has theoretical advantages of very minimal tissue penetration and minimal to no charring effect. In this trial, the investigators compare the efficacy and safety of both electrosurgical modes in POEM procedures.

NCT ID: NCT06044155 Recruiting - Achalasia Clinical Trials

redoPOEM : Failure of a First POEM

redoPOEM
Start date: October 3, 2023
Phase:
Study type: Observational

observational study, measurement of efficacy in the cohort.

NCT ID: NCT05899842 Recruiting - Clinical trials for Esophageal Achalasia

Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia

IPPOEM
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Per Oral Endoscopic Myotomy (POEM) is a treatment of choice for achalasia with an excellent safety and efficacy profile. There is a high rate of esophagitis related to gastroesophageal reflux following this procedure. There is no recommendation on the prescription of protein pump inhibitors (PPI) after the procedure and no study has studied the benefit of systematic prescription of PPI after POEM for achalasia. The study authors hypothesize that routine PPI prescribing post-POEM for 12 months would reduce the rate of esophageal acid exposure compared to a symptom-based prescribing strategy.

NCT ID: NCT05772260 Recruiting - Achalasia Clinical Trials

Autonomic Dysfunction and Hemodynamic Instability During Per-oral Endoscopic Myotomy

Start date: April 3, 2023
Phase:
Study type: Observational

This prospective observational study aims to investigate the association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy under general anesthesia in achalasia patients. Per-oral endoscopic myotomy is known as the effective treatment for achalasia patients. During per-oral endoscopic myotomy, capnoperitoneum, capnomediastinum, and systemic CO2 accumulation can potentially impair hemodynamics. Moreover, it has been suggested that achalasia is associated with autonomic dysfunction. We hypothesized that patients with autonomic dysfunstion would esperience more hemodynamic instability during per-oral endoscopic myotomy compared with patients without autonomic dysfunction. In this prospective observational study, the autonomic function test will be performed before surgery, and advanced hemodynamic parameters will be recorded using EV1000 clinical platform (Edwards Lifesciences, USA) during surgery. The association between the autonomic dysfunction and hemodynamic instability during per-oral endoscopic myotomy will be analyzed.

NCT ID: NCT05602272 Recruiting - Gastroparesis Clinical Trials

Respiratory and Hemodynamic Implications of Endoscopic Myotomy of the Esophagus and Stomach

Start date: November 1, 2022
Phase:
Study type: Observational

The goal of this observational study is to learn about hemodynamic and respiratory repercussions during general anesthesia in patients with achalasia or gastroparesis who underwent an endoscopic treatment such as a peroral endoscopic myotomy (POEM) or gastric (GPOEM). The main questions it aims to answer are: - Are there predictable elements reliable to this study-population for the occurrence of adverse events/complications? - Is there a correlation between the value (percutaneous puncture) of the intra-abdominal pressure and the variations of the patient's respiratory and hemodynamic parameters in the event of a pneumoperitoneum complication? Participants will be treated with the usual standard of care for this procedure and no additional or specific therapy will be planned for this study.

NCT ID: NCT05550194 Recruiting - Achalasia Clinical Trials

VZV in the Enteric Nervous System: Pathogenesis and Consequences

Start date: March 27, 2023
Phase: Phase 4
Study type: Interventional

Varicella zoster virus (VZV) is the cause of chickenpox and shingles, but it also infects, becomes latent, and reactivates in nerve cells of the bowel to cause a gastrointestinal disorder ("enteric shingles"). The Investigators recently found that a chronic active VZV infection, a form of enteric shingles, is associated with achalasia, a severe disease in which the passage of food from esophagus to stomach is impaired. We now propose to eradicate VZV to determine whether its association with achalasia is causal, to identify the genetic basis behind VZV reactivation in the esophagus, and the relationship of mast cells to enteric shingles and abdominal pain.

NCT ID: NCT05326113 Recruiting - Achalasia Clinical Trials

The Effect of Physiotherapy on Post POEM Reflux

Start date: October 31, 2021
Phase: N/A
Study type: Interventional

Per-oral endoscopic myotomy has been used as a treatment method of esophageal achalasia. Patients who undergo POEM as a treatment of achalasia are often presented with development of reflux as a side effect of the surgery. Patients are then in need to use proton pump inhibitor drugs as a long term treatment of the reflux symptoms. Physiotherapy aimed on the strengthening of diaphragm and lower esophageal region is effective in gastroesophageal reflux disease. Therefore we are expecting positive effect of physiotherapy in post POEM patients with reflux symptoms and the possible reduction of PPI drug usage need. The aim of the study is to objectify the effect of physiotherapy, to describe in detail the used physiotherapeutic techniques and to develop practical guidelines for the treatment of patients after POEM with GERD.