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NCT01793922
The aim of the study is to compare the efficacy of per-oral endoscopic myotomy (POEM) to the efficacy of pneumodilation as the initial treatment of symptomatic idiopathic achalasia. It is hypothesized that POEM has a higher long-term efficacy than pneumodilation in treatment of therapy-naive patients with idiopathic achalasia.
NCT07458555
To understand the impact of commonly used anesthetics on esophageal motility during FLIP topography.
NCT07451301
Achalasia is a rare esophageal motility disorder characterized by impaired relaxation of the lower esophageal sphincter and progressive esophageal dilation. Increasing evidence suggests that autoimmune mechanisms may contribute to its development. Serum anti-enteric neuronal antibodies (AENA) have been reported more frequently in patients with achalasia than in healthy individuals. This study aims to evaluate the association between AENA levels and disease severity in patients with achalasia. Specifically, it aims to determine whether the intensity of AENA positivity is associated with endoscopic severity (measured by the CARS score), esophageal dilation, and integrated relaxation pressure. The study also aims to assess whether AENA status is associated with symptomatic outcomes following peroral endoscopic myotomy (POEM). The objective is to determine whether AENA may serve as a potential biomarker for identifying patients with a more severe disease phenotype and less favorable treatment response.
NCT07425977
Peroral endoscopic myotomy (POEM) is a minimally invasive endoscopic procedure used to treat achalasia and other spastic esophageal motility disorders. A key step in POEM is creating a small opening in the esophageal lining (mucosal incision) to enter the submucosal tunnel. This study evaluates whether making that entry incision \*\*transverse\*\* (across the esophagus) versus \*\*longitudinal\*\* (along the esophagus) improves procedural efficiency without reducing safety. This is a \*\*multicenter, randomized (1:1), parallel-group clinical trial\*\* conducted in three therapeutic endoscopy units in Colombia (Hospital Universitario del Valle and Clínica Versalles in Cali, and Clínica del Occidente in Bogotá). Adults (≥18 years) with an indication for POEM, ASA I-III, and ability to provide informed consent will be eligible; key exclusions include prior myotomy/major esophageal surgery, uncorrectable coagulopathy, pregnancy, active systemic infection, anesthesia contraindication, or anticipated technical inability to perform POEM. All procedures are standardized: POEM under \*\*general anesthesia with orotracheal intubation\*\*, \*\*CO₂ insufflation\*\*, validated endoscopic knives and preset electrosurgical modes; hemostasis with \*\*Coagrasper® only if needed\*\*; and closure using standard \*\*through-the-scope (TTS) clips\*\*. Participants are randomly assigned to a \*\*15 mm transverse mucosal incision\*\* (perpendicular to the esophageal axis) or a \*\*15 mm longitudinal mucosal incision\*\*. Full-procedure video is recorded for quality control and to allow objective timing, with blinded assessment of the primary outcome. The \*\*primary outcome\*\* is the time (seconds) from the first mucosal cut to successful entry of the endoscope cap into the submucosal tunnel (advancing at least 1 cm). \*\*Secondary outcomes\*\* include need for hemostasis with Coagrasper®, number of clips required for complete closure, and early complications (including perforation and gas-related events such as capnoperitoneum requiring decompression and emphysema), monitored through \*\*30 days\*\*. Participants complete a screening/preoperative visit (up to 30 days before), undergo the POEM procedure, have early in-hospital/discharge assessment (days 1-2), and receive safety follow-up contacts at approximately 1 week and day 30. Risks are those expected from standard POEM and peri-anesthesia care (e.g., bleeding, perforation, infection, and gas-related complications), and participants may not directly benefit clinically. However, the transverse incision may shorten access and closure time and reduce resource use without increasing short-term complications. The study will be conducted with written informed consent, confidentiality protections (pseudonymization and secure storage), and reporting of results in aggregate form.
NCT07406945
Achalasia is an idiopathic motility disorder, primarily identified by the absence of esophageal peristalsis and the inability of the lower esophageal sphincter (LES) to relax properly. Although it is usually misdiagnosed and treated as gastroesophageal reflux disease (GERD), the main symptom is progressive dysphagia, accompanied by additional symptoms like nocturnal cough, heartburn, weight loss, regurgitation of undigested food and aspiration. The severity of achalasia and the effectiveness of treatments are commonly assessed using the Eckardt Symptom Score (ESS), which evaluates symptoms like weight loss, regurgitation, dysphagia, and retrosternal pain. Diagnosis of achalasia is often delayed, affecting up to 50% of patients. It typically involves a combination of diagnostic tools, such as time barium esophagram (TBE) study, which assesses the movement and clearance of barium in the esophagus; esophagogastroduodenoscopy (EGD), which allows visual examination of the esophagus, stomach, and duodenum; and high-resolution esophageal manometry (HREM), considered the gold standard for achalasia. HREM can also help stratify the condition into different types, influencing treatment choices. Furthermore, the endoluminal functional lumen imaging probe (Endoflip, Crospon Corp, Dangan Galaway, Ireland), which measures baseline parameters of LES, aiding in both diagnosis and treatment evolution. While there is no cure for achalasia, treatments aim to reduce LES pressure. The include pharmacological treatments, such as calcium channel blockers or nitrates; endoscopic treatment, including injection of botulinum toxin in the LES, pneumatic dilation, or per-oral endoscopic myotomy (POEM); and surgical therapies (laparoscopic Heller myotomy). POEM has emerged as a first-line treatment for achalasia due to its minimally invasive nature and high success rates (80%-90%). This technique involves creating a submucosal tunnel and performing myotomy, and it can be performed anteriorly (at 2 o'clock) or posteriorly (at 5 o'clock). The choice between anterior and posterior approaches to POEM often depends on the endoscopist's experience and preference. While current data is inconclusive regarding the superiority of either approach, some suggest that the posterior approach might be technically easier due to procedural characteristics (i.e., alignment between endoscopic accessories and mucosal incision). The introduction to novel technologies with smaller diameters can improve this minimally invasive approach making the procedure more efficient and safer for patients with achalasia. Thus, we aim to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for per-oral endoscopic myotomy in patients with achalasia.
NCT01799967
This study will assess short and long term outcomes of individuals undergoing minimally invasive surgery of the gastro-esophageal junction (MISGEJ). Patients will respond to questionnaires on an annual basis evaluating quality of life and functionality following MISGEJ. Hospital charts will also be reviewed on an annual basis to assess patient health outcomes.
NCT07334639
This goal of the study is to assess the effect of weight gain in patients with achalasia after they are treated. The main question to be answered is if weight gain after achalasia treatment is associated with worsening metabolic status. Patients will be compared between their baseline status at the time of treatment and 1 year after treatment. Participants will have metabolic tests performed at these 2 times including blood tests.
NCT07287787
The aim of this study is to compare the clinical efficacy, safety, and technical outcomes of per-oral endoscopid myotomy( POEM )in treatment-naïve achalasia patients versus patients with previous pneumatic dilation. * Study subjects: 1. Inclusion criteria: Adult patients diagnosed with achalasia (Chicago classification types I-III by High resolution manometry (HRM) ). 2. Exclusion criteria: 1. Children below 18 yr. 2. Prior surgical myotomy. 3. pregnancy Groups: * Group I (Naïve group): Patients undergoing POEM as primary therapy. * Group II (Prior Pneumatic Dilation group): Patients undergoing POEM after failed or relapsed pneumatic dilation. Data analyzed included the following: * Baseline: basic demographic information, Eckardt score , manometry(HRM) , timed barium esophagogram and history of pneumatic dilation . * Perioperative parameters (Disease duration, Surgical time, Length of hospital stay, mucosal edema, and mucosal injuries). * Intraoperative (mucosal perforation ,bleeding in submucosal space ,pneumoperitoneum ,pneumomediastinum,pneumothorax or incompelet myotomy )and postoperative complications (Infections,esophageal leak ,subcutaneous emphysema, GERD,esophagitis ) . * Post procedure symptoms evaluation (Eckardt score) at 1, 3\&6 months after the procedure . Eckardt score : It is a 12-point score which is as following : 0 1 2 3 Recent weight loss (kg) none \<5 kg 5-10 kg \>10 kg Dysphagia none occasional daily each meal Retrosternal chest pain none occasional daily each meal Regurgitation none occasional daily each meal A score of ≥3 is suggestive of active achalasia. POEM technique : Briefly, the procedure included submucosal injection at the 5-6-o'clock position entry point, and mucosal incision at the posterior wall about 8-10 cm above the esophageal-gastric junction (EGJ), entry into the tunnel by clearing submucosal fibers, and then myotomy initiating about 2 cm down from the mucosal incision and extending 2-4 cm into the cardia. Afterwards, the mucosal incision will be closed using endoclips. In special circumstances, when fibrosis or adhesions present because of prior PD, the myotomy will be located in an area of normal (fibrosis-free) tissue, and a long myotomy will be made. Technical success was defined as a successful completion of the entire POEM procedure. Clinical success was defined as a post-POEM Eckardt score of 3. * Research outcome measures: 1. Primary (main): Clinical success at 3 and 6 months (Eckardt score ≤ 3 ) 2. Secondary (subsidiary): * Technical success * Procedure time * Intra- and post-operative complications. Data management and analysis : Data will be collected first in sheets, and then will be in Master sheet. Data of every patient will be coded. This will be done using SPSS. Categorical data were presented as number and percentage. Continuous data is presented as mean and standard deviation (SD) if normally distributed or median and interquartile range (IQR) if non normal distributed. Other test will be used according to the results and relations needed to be studied.
NCT04641702
The prospective clinical trial will study muscle fibrosis in relation to lower esophageal sphincter (LES) measurements on Functional Lumen Imaging Probe (FLIP) Topography (the novel technology that utilizes impedance planimetry) after pharmacologic challenge. A better understanding of achalasia will allow intervention at an earlier stage.
NCT01512719
POEM has recently described as an alternative treatment for achalasia in humans. In this procedure the esophageal sphincter is incised through a submucosal tunnel in the esophagus. In this study we aim to perform POEM on achalasia patients.
NCT07167355
To compare the efficacy of balloon dilatation (BD) and per oral endoscopic myotomy (POEM) in improving the symptoms of children with achalasia in short and long term Presently most guidelines such as American Society for Gastrointestinal Endoscopy (ASGE) or European Society for Gastrointestinal Endoscopy (ESGE) recommend POEM or LHM or BD for the management of achalasia cardia based on the institutional expertise and patient preference. Only the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recommend POEM or LHM over PBD for the management of achalasia in children. This is due to the lack of pediatric randomised control trial comparing the efficacy and safety of the two methods both in long and short term. Children 3-18 years of age diagnosed as a case of achalasia cardia Place of trial: Department of medical gastroenterology, AIG Hospitals, Gachibowli and Somajiguda/Banjara Hills Duration of the trial: 3-4 years Sample size: 70 (35 each arm) Inclusion criteria: All children diagnosed as a case of achalasia cardia aged 3-18 years Exclusion criteria: Children who have undergone prior BD or POEM or Heller's myotomy. Type 3 achalasia cardia. Prior oesophageal/gastric surgery. Coagulopathy. Patients refusing consent for the trial. Primary outcome: Percentage of children with achalasia cardia achieving a clinical success of BD and POEM at 12 months post intervention (clinical success is Eckardt score ≤ 3 and timed barium esophagogram (TBE) showing a holdup at gastroesophageal junction of \<5cm at 5 minutes without requirement of further intervention) Secondary outcomes: Major and minor treatment complications, percentage patients developing gastroesophageal reflux disease, procedure time and improvement in growth Randomization: A stratified block randomization shall be performed using computer generated random number tables BD arm: Children \<7 years of age will under 1-2 sessions of BD 1month apart with CRE 20mm balloon. Children 7-17 years of age will undergo 1-2 sessions of BD with Rigiflex II, Achalasia balloon dilator (30mm followed by 35mm). POEM arm: Children 3-17 years of age will undergo 1 session of POEM as per the unit protocol. Outcomes will be assessed at 3,6,12 months of the index procedure Crossover: If Eckardt score \>3 and TBE showing a stasis of \>5cm at 5 minutes, treatment is considered to have failed and crossover will be offered Endpoints: One year of follow up from the initial intervention or one year of follow up of the crossover intervention (in case of treatment failure), major complications. Interim analysis: Following completion of follow up of 50% of the trial participants Early termination of trial: In case of any treatment modality having \>10% major complications or during interim analysis one treatment modality significantly better than other (p\<0.003)
NCT06883175
Swallowing difficulties are extremely common and result in substantial morbidity, reduction in the quality of life, and mortality related to malnutrition and complications from regurgitation and aspiration. Unfortunately, our understanding regarding the pathophysiology of dysphagia and GERD has been hampered by focusing predominantly on circular muscle activity and ignoring the essential biomechanical properties of the esophageal wall that promote normal emptying. Our initial work explored the relationship between intrabolus pressure (IBP) and esophagogastric junction (EGJ) compliance as a metric for outflow resistance. This work highlighted the direct relationship between IBP and EGJ opening and was the foundation for the development of the classification scheme utilized around the world to diagnose esophageal motor disorders: "the Chicago Classification" (CC). Despite this improved understanding focused on bolus transit dynamics, there are still significant gaps in our scientific understanding centered on the lack of a true correlate for symptoms, reliable predictive models and effective treatments for Functional dysphagia, IEM and EGJOO. Given these limitations, we have developed novel approaches that combine assessments of primary and secondary peristalsis (a NeuroMyogenic Model of esophageal function). These will leverage our recent findings supporting the importance of the esophageal response to distension in bolus clearance, noting that this response of the esophageal wall to bolus retention or reflux is one of the most essential functions of the esophagus in preventing complications of aspiration, or reflux injury. We will also include an assessment of esophageal geometry and wall biomechanics (elasticity/dilatation) as these carry essential interactions with esophageal function that are overlooked in the current diagnostic paradigms. In order to test our hypothesis that wall mechanics are a major determinant of esophageal diseases, we had to develop new approaches and new technology to directly measure mechanical wall state, descending inhibition and LES opening. Using impedance techniques combined with manometry, we are now capable of assessing IBP and diameter changes across a space-time continuum (4D HRM). We also developed physics-based hybrid diagnostics that include a FLIP technique to assess esophageal work and power during volumetric distention (FLIP-MECH) and a fluoroscopy approach that simultaneously assesses esophageal diameter-pressure relationships (Fluoro-MECH). We also developed a new approach, Interactive FLIP Panometry, which facilitates an assessment of descending inhibition and the mechanism behind impaired LES opening. These tools will allow us to expand our models to combine an assessment of neuromyogenic function simultaneously with geometry. Our overarching goal will be to study well-defined patient populations (Functional Dysphagia, IEM/GERD, EGJOO and Achalasia) before and after targeted interventions to test the NeuroMyogenic and MechanoGeometric Model. This work will build upon the previous success of the CC and help advance the evolution of the CC by defining new, relevant biomechanical physiomarkers of disease activity that can identify new targets for therapeutic intervention and facilitate prediction of clinical outcomes.
NCT05550194
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.
NCT06189859
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.
NCT01832779
Achalasia is a chronic disease of altered esophageal motility with resulting functional obstruction to the passage of food leading to poor quality of life and significant morbidity. The two main treatments available in the US are endoscopic balloon dilation and surgical myotomy. Each therapy has advantages and drawbacks and at present both are considered a first choice approach depending on patient preferences and local expertise. Surgical myotomy provides long lasting improvement in dysphagia but even when done laparoscopically is invasive and complex. Extensive acid reflux resulting in significant morbidity is routinely seen after surgical myotomy and additional anti-reflux operation is typically done at the time of the myotomy. Endoscopic balloon dilation is a simple minimally invasive outpatient procedure but improvement of symptoms tends to be shorter in duration and repeat dilations are commonly needed. Both therapies improve on dysphagia but tend to provide suboptimal control of chest pain which is one of the cardinal symptoms of achalasia. The peroral endoscopic myotomy (POEM) was first introduced in Japan to address the suboptimal results with endoscopic balloon dilation and surgical myotomy. POEM is incisionless minimally invasive but in addition may have some further advantages over surgical myotomy including unlimited length of the myotomy with expected better control of chest pain and preservation of the anatomical anti-reflux barrier (angle of His and the cruse of the diaphragm) with expected lower incidence of acid reflux. In Japan POEM has become the preferred modality for therapy of achalasia due to the excellent results and exceptional safety record. In the US, dedicated POEM devices were approved by the FDA just recently. As a result the bulk of the published data comes from Japan and very little is known regarding outcomes in US population. Therefore the investigators want to prospectively record our experience with POEM as done as part of routine medical care in US population. This will be a data recording study. All patients will receive standard medical care and no experimental interventions will be performed.
NCT06044155
observational study, measurement of efficacy in the cohort.
NCT06213662
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.
NCT04798547
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.
NCT05326113
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.
NCT06264466
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.