View clinical trials related to Esophageal Achalasia.
Filter by:The goal of this prospective observational study is to evaluate the role of nasogastric tube (NGT) in patients with achalasia underwent to Heller-Dor laparoscopic. The main question it aims to answer are: • If it is possible to remove NGT at the end of surgery. Participants will be dived in two groups: the first one with NGT after surgery and second one without NGT (noNGT). If there is a comparison group: Researchers will compare group NGT and group noNGT to see if routine placement of NGT is useless.
Achalasia is a rare motility disorder of the oesophagus that is characterized by aperistalsis of the oesophagal body and dysrelaxation of the lower oesophagal sphincter (LES). Current treatment is palliative, and the aim of the treatment is to diminish the obstructive function of the esophagogastric junction (EGJ). Due to this approach, the most frequent complication post-treatment is gastroesophageal reflux (GER). However, not every treated patient develops GER symptoms and the mechanism behind the occurrence of GER in treated achalasia are unclear. In this study, we aim to Investigate the incidence of reflux in patients after peroral endoscopic myotomy in patients with achalasia cardia.
The objective of this randomized controlled trial (non-inferiority study) is to evaluate the outcomes of 4 cm short myotomy compared to the 8 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for patients with achalasia. We hypothesize that a shorter myotomy with POEM will have the same clinical efficacy as standard length myotomy based on patient-reported Eckardt score with shorter procedure times and reduced complications.
Esophageal mucosal changes in long standing achalasia cardia and reversibility after per oral endoscopic myotomy - A pilot study Aims and Objectives: - To study mucosal changes in patients with achalasia cardia - To study potential malignant histopathological findings in long standing achalasia cardia - To assess reversibility of mucosal changes after POEM - To study co-relation of mucosal histopathology with predictors of sub-mucosal fibrosis - To study muscle biopsy by light microscopy and electron microscopy for viral inclusions Materials and Methods: - Study Area - Patients of achalasia cardia undergoing POEM in Asian Institute of Gastroenterology. - Study Design - Cross sectional study Inclusion Criteria: •All patients of achalasia cardia who will undergo POEM and an esophageal mucosal biopsy at 3 months of follow up Exclusion Criteria: - Patients of achalasia cardia not undergoing POEM or an esophageal mucosal biopsy at 3 months of follow up - Upper gastro-intestinal surgically altered anatomy ( apart from previous Heller Myotomy ) - Pregnancy - Patients not giving consent for participation - End Point( Length of follow up )- 3 months after POEM - single follow up. Study Procedure: Before POEM, all patients will undergo symptom evaluation, esophagogastroduodenoscopy (EGD), high resolution esophageal manometry and timed barium esophagogram.The diagnosis of achalasia will be based on a combination of clinical presentation, esophagogastroduodenoscopy, barium esophagogram and high resolution manometric findings. Symptoms will be classified by using the Eckardt score.Type of Achalasia will be classified according to the Chicago classification. Esophagus shape (sigmoid vs nonsigmoid), presence of hiatus hernia, presence of esophagitis will be assessed on esophagogastroduodenoscopy. Duration since first symptoms of achalasia will be recorded. All patients fulfilling the inclusion criteria will undergo Per Oral Endoscopic Myotomy (POEM). During POEM, a mucosal biopsy and a muscle biopsy of the Esophagus will be taken. Patients will be followed up at a single time, 3 months after POEM. During the follow up visit, patients will undergo esophagogastroduodenoscopy guided mucosal biopsy of the Esophagus. Patients will be divided into two groups based on the duration of symptoms of achalasia- Those having symptoms for 1 year or less and those having symptoms for more than 5 years. Histopathological changes in the Esophagus and reversibility of these changes after POEM will be compared between the two study groups to draw a conclusion.
In this study, we will evaluate the incidence of reflux esophagitis between two different techniques of posterior per-oral endoscopic myotomy (POEM) i.e. conventional POEM versus oblique/ sling fiber sparing POEM. This is a randomized trial where the patients with idiopathic achalasia will be randomized in two groups in 1:1 fashion into groups.
Therapy for end-stage achalasia is under debate: comparative data on the long-term functional results of myotomy and oesophagectomy are lacking. The study aimed to compare the objective outcomes and quality of life after oesophageal myotomy and oesophagectomy. The study included 31 patients (57 years) who underwent the Heller-Dor procedure with verticalisation of the distal oesophagus (pull-down technique dedicated to sigmoid oesophagus treatment) and 29 patients (recurrence free, 64 years) (p=0.539) who underwent oesophagectomy for end-stage achalasia or for cancer, extracted from a database designed for prospective clinical research. The objective outcomes of treatment were evaluated with semi-quantitative scales investigating dysphagia, reflux symptoms and endoscopic oesophagitis. Quality of life was assessed with the SF-36 questionnaire.
Achalasia is a primary esophageal motility disorder characterized on high-resolution manometry (HRM) studies by 100% failed peristalsis and elevated integrated relaxation pressure of the lower esophageal sphincter. It is further divided into 3 sub-types according to the Chicago classification v3.01. The pathophysiology of achalasia is poorly understood; however, the NGEU is increasingly recognized as playing a key role in the development of this disorder. Similarly, the esophageal muscle tissue is probably involved, but its sampling remained challenging until the recent advent of the POEM procedure. Indeed, it is now possible, easy and safe to take biopsies of the muscle tissue during POEM. Therefore, POEM not only represents an innovative and effective treatment for achalasia, but also an opportunity to better understand its underlying pathophysiological mechanisms. Currently available treatments for achalasia (pneumatic dilation (PD), Heller's myotomy (HM), botox injections, POEM) are "palliative" procedures that do not restore normal contractile function of the esophagus, but a better understanding of the pathophysiological mechanisms underlying this disorder could potentially help developing curative, or even preventative treatments. To date, muscle tissue sampled during a POEM has only been characterized qualitatively (normal, atrophic, hypertrophic) with no assessment of the enteric nervous system. Moreover, there has been no studies of the mucosal or NGEU anomalies on biopsies taken during a minimally invasive procedure for achalasia such as a POEM. This study aims to evaluate the feasibility of the assessment of NGEU and esophageal muscle tissue in biopsies taken during a POEM for achalasia. It also aims to determine whether specific biomarkers within the NGEU and muscle tissue can predict a better therapeutic response to a POEM. The goal is to include 30 patients within 12 months. Given that approximately 100 new cases of achalasia are diagnosed each year at the included centers, and that about 50% of treatment-naive patients are offered and accept to undergo a POEM, recruitment should be completed relatively rapidly. All POEMs will be performed at the CHU de Nantes by a single endoscopist who has already performed more than 100 procedures. Other than the complications related to the POEM itself, the addition of 14 esophageal biopsies required for our study is a very low-risk intervention. Biopsy sampling extends the length of the procedure by only 4-5 minutes and has not been associated with an increased risk of complications in a previous study. Patients will be evaluated at five time points: preinclusion visit (up to four months before the POEM), inclusion visit (day of the POEM), post-POEM phone calls (3-6, 9-12, 22-26 months after POEM). During the preinclusion visit, relevant information regarding inclusion/exclusion criteria, consent, HRM and pH impedance results, past medical history, and pregnancy status (if applicable) will be gathered. At each time point, current medical history, Eckhardt score2 and pH impedance results (if available) will be documented. The patient will also answer the quality of life (SF36)3 and nutritional status questionnaires and will undergo blood sampling for albumin and prealbumin levels. Additionally, on the day of the POEM, there will be another blood sampling for complete blood count, PT, APTT, serum electrolytes and CRP level. Finally, at each post-POEM phone calls, the occurrence of adverse events will be reported. Our primary hypothesis is that the analysis of mucosal and muscle tissue biopsies taken safely during a POEM will allow better characterization of transcriptomic and molecular remodeling of the mucosa (especially the NGEU) and the muscularis propria in achalasia. We also hypothesize that these anomalies could eventually serve as treatment targets and as a way of better stratifying patients according to achalasia type and treatment (in our case, POEM) response.
No recommendation regarding antibiotic prophylaxis and preparation modalities are available for patients with esophageal motor disorders who benefit from Per-Oral Endoscopic Myotomy (POEM). The aim of our study was to evaluate the impact of antibiotic prophylaxis on the POEM's safety. This study was a comparative and multicentric retrospective analysis of a database prospectively maintained. Patients over 18 year's old with esophageal motor disorders confirmed by prior manometry, who underwent POEM were included. The primary endpoint was the occurrence of complications, as classified by Cotton, based on whether or not antibiotic prophylaxis was administered.
POEM (Peroral Endoscopic Myotomy) is an endoscopic procedure most commonly used to treat achalasia. Achalasia is a disorder resulting from the inability of esophageal muscles to relax.The POEM procedure, performed under general anesthesia, involves inserting an endoscope into the esophagus where a specialized knife is able to cut a new pathway through the esophageal tissue. The knife is then used to incise, and therefore loosen, tight muscles within the esophagus, lower esophageal sphincter, and the upper region of the stomach that are responsible for the symptoms.This study seeks to improve patient's post-operative pain levels by placing ropivacaine (a local anesthetic) into the newly cut pathway that is created in the POEM procedure. It is hypothesized that the topical irrigation of the POEM tunnel with ropivacaine will result in decreased pain scores and a decreased need for additional pain medications.
Background: Achalasia is a primary rare esophageal motor disorder of the esophagus (annual incidence of 1:100,000 persons). Recently, a new endoscopic technique, Per-Oral Endoscopic Myotomy (POEM), has been introduced with excellent success rates. Several studies have evaluated complications of POEM but there is a lack of knowledge on the potential risk of bacteremia or microbial translocation during the endoscopic intervention and, also, there aren't evidences regarding the use of antibiotics before/after POEM. Microbial translocation (MT) is the passage of both viable and nonviable microbes across the anatomically intact GI barrier to the mesenteric lymph nodes, and possibly other tissues. Gram-negative bacteria contain lipopolysaccharides (LPSs) coating their thin peptidoglycan cell wall. The presence of LPS, an endotoxin, in the plasma has been correlated to sepsis and septic shock through the activation of the inflammatory host defence via binding to soluble CD14 (sCD14) which initiates downstream cytokines (like IL-6, IL-8 and tumor necrosis factor (TNF-α)) and, also, through the production of sCD14 and LPS-binding protein (LBP) by the innate immune system. Objectives: Considering POEM a clean-contaminated procedure, it should be assessed whether the post-POEM fever or systemic inflammation is a cytokinin-mediated or an infection-related fever. Thus, aim of the study is to evaluate the presence of inflammation mediators, bacteremia and microbial translocation post POEM, to guide future antibiotic prophylaxis/therapy in patients undergoing this procedure. Methods: All patients who will undergo POEM at _Investigator's Department from June 2017 to June 2019 will be enrolled in a prospective, interventional randomized clinical trial (RCT). Patients will be randomized in two groups. The Group A, prophylaxis group, will receive antibiotics (Cefazolin 2 gr i.v.) only before procedure whereas Group B, short therapy group, will receive antibiotics before POEM (Cefazolin 2 gr i.v.), continued for the first 24 hours and then per os (Amoxicilline/Clavulanic Acid 3 gr/die) for 3 days. For each patient we will be evaluated: dosage of IL-6, IL-1β, TNF-α, sCD4, LPB, LPS and blood cultures. Expected results: we expect that the prophylaxis group vs short therapy group, has a prevalence of fever and/or systemic inflammation not higher than 10% difference of the fever related to the procedure.