Clinical Research Directory

The Impact of Anesthetics on FLIP

To understand the impact of commonly used anesthetics on esophageal motility during FLIP topography.

Metabolic Changes Associated With Weight Gain After Treatment of Achalasia

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.

Comparative Study of Per-oral Endoscopic Myotomy (POEM) in Treatment - naïve Achalasia Patients Versus Patients With Previous Pneumatic Dilation

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.

Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD

Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief. However, a significant drawback is the high incidence of gastroesophageal reflux disease (GERD) following the procedure. One proposed technical modification, the selective preservation of the sling fibers during gastric myotomy (SFP-POEM), may reduce this risk without compromising efficacy as compared to a conventional POEM procedure, which includes myotomy of the sling fibers. In this study, adults with achalasia will be randomly assigned to receive one of the two POEM technical approaches. Researchers will monitor whether preserving sling fibers reduces the rates of reflux esophagitis (classified as Los Angeles Grade B or higher) on follow-up endoscopy. Participants will be followed for up to 1 year after the procedure.

The Use of Indocyanine Green Fluorescence (ICG) During Laparoscopic Heller- Dor

The aim this prospective observational study is to evaluate the role of Indocyanine Green Fluorescence (ICG) in patients with achalasia underwent to Heller-Dor laparoscopic. The main gol are: * If with use of ICG iatrogenic mucosal leaks can be identified and, if necessary, improve the myotomy. * Assess the need for postoperative radiographic control using esophagogastric radiography with gastrografin. * Compare clinical characteristics, perioperative outcomes, and 12-month postoperative follow-up between the two populations.

Evolution of the Chicago Classification: Bridging Physiology and Mechanics

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.