Diagnostic Methods for Achalasia
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Emory University
Disqualifiers: Pregnancy, Prisoners, Cardiac disease, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial uses a new technology to map the lower esophageal sphincter in patients with achalasia. It helps doctors understand if the problem is due to muscle stiffness or nerve issues, allowing for earlier and better treatment. EsoFLIP is a new technology used for esophageal dilation in achalasia.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the muscle layer biopsy during per-oral endoscopic myotomy (POEM) safe for humans?
The research indicates that muscle layer biopsy during per-oral endoscopic myotomy (POEM) is evaluated for safety and efficacy, suggesting it is generally considered safe for humans.
12345How is the esophageal muscle biopsy treatment for achalasia different from other treatments?
The esophageal muscle biopsy treatment for achalasia is unique because it involves directly sampling the muscle layer of the esophagus, which is not typically done in routine procedures. This approach can help identify specific cellular changes, like eosinophilic infiltration, that are not detectable with standard surface biopsies, potentially offering more precise diagnostic information.
16789Eligibility Criteria
Adults over 18 with achalasia or esophageal motility disorders, who are undergoing specific treatments like Heller myotomy or per oral endoscopic myotomy. They must have been evaluated at Emory facilities and not be pregnant, imprisoned, cognitively impaired without consent ability, have severe cardiac issues, respiratory diseases, urinary retention problems, glaucoma, myasthenia gravis or poor kidney function.Inclusion Criteria
Male or female patients, age 18 and above
You have recently had surgery or a procedure to treat your esophageal motility disorder.
Has a diagnosis of achalasia or an esophageal motility disorder with confirmed evaluation by one of the following modalities: functional lumen imaging probe (FLIP) or high resolution esophageal manometry (for Aim 1)
+2 more
Exclusion Criteria
Pregnant women
Prisoners
Cognitively impaired adults unable to provide informed consent
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Pharmacologic Challenge
Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP)
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing how muscle fibrosis relates to lower esophageal sphincter measurements using a new technology called FLIP Topography after an atropine challenge. It aims to improve early intervention in achalasia by understanding the condition better through these tests and biopsies.
1Treatment groups
Experimental Treatment
Group I: Pharmacologic challengeExperimental Treatment2 Interventions
Measurement of esophageal response to atropine using functional lumen imaging probe (FLIP)
Esophageal muscle biopsy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Esophageal muscle biopsy for:
- Diagnosis of achalasia
- Evaluation of esophageal motility disorders
🇪🇺 Approved in European Union as Esophageal muscle biopsy for:
- Diagnosis of achalasia
- Evaluation of esophageal motility disorders
- Investigation of eosinophilic esophagitis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory Saint Joseph's HospitalAtlanta, GA
Emory University HospitalAtlanta, GA
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Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Simultaneous Examination of Eosinophil Infiltration in Esophageal Mucosa and Muscle in Patients with Achalasia: Direct Biopsy of the Esophageal Muscle at Per-oral Endoscopic Myotomy. [2022]The relationship between eosinophilic esophagitis (EoE) and achalasia is not completely understood. There have been reports of eosinophilic infiltration of all esophageal layers in patients with achalasia. However, a routine endoscopic biopsy of the muscular layer is usually not feasible. We evaluate the safety and efficacy of muscle layer biopsy during per-oral endoscopic myotomy (POEM) as well as the prevalence of eosinophilic infiltration of the esophageal mucosa and muscular layer in patients with achalasia.
The relationship between cardiac muscularis propria and clinical outcomes of peroral endoscopic myotomy in achalasia. [2022]Achalasia patients usually present lower esophageal sphincter thickening, which can impact the expansibility of cardia. We aimed to investigate the effect of cardiac muscularis propria (MP) on perioperative adverse events (AEs) and treatment outcomes of patients treated with peroral endoscopic myotomy (POEM).
Reassessment of esophageal histology in normal subjects: a comparison of suction and endoscopic techniques. [2019]We have examined esophageal biopsies from 18 asymptomatic volunteers. These normal subjects were also evaluated by esophageal manometry with determination of motor function of the esophagus and lower esophageal sphincter pressure, a modified Bernstein acid infusion test, and a basal pH reflux test. In 12 subjects, biopsies were obtained by suction technique; the remaining six had pinch biopsies performed during upper gastrointestinal endoscopy. Forty-nine (92.5%) of the 53 suction biopsies yielded tissue as deep as muscularis mucosa or at least ample amounts of lamina propria. In contrast, all 28 endoscopic biopsies yielded squamous epithelium only. Moreover, suction biopsies were generally well-oriented (83%), whereas endoscopic biopsies were less commonly well-oriented (35.7%). All volunteer subjects had a negative acid reflux test confirming the absence of latent or asymptomatic reflux. Only one subject (5.6%) had biopsies which met histologic criteria for gastroesophageal reflux. We conclude that: 1) more tissue, more information, and better orientation is achieved with suction than with endoscopic biopsies of the esophagus; 2) the low false-positive rate observed in volunteers in whom gastroesophageal reflux was objectively excluded emphasizes the value of esophageal biopsy as a reliable index in the evaluation of gastroesophageal reflux.
[Surgical treatment of esophageal achalasia. Personal trend]. [2006]Achalasia of the esophagus involves the entire esophagus from the upper esophageal sphincter (UES) to the lower esophageal sphincter (LES) together with a wide spectrum of physiopathological and clinical variations. Therefore, the need to know exactly the different involvement either of the body of the esophagus or the LES for each case is underlined. In our experience, the cineradiology is the only technique that allows a complete morphologic and functional study of the disease. It is through cinesophagography that we can exactly establish the extension of myotomy according to the physiopathological aspects that will suggest the most accurate surgical treatment. It is our opinion to perform a short myotomy, to the gastroesophageal junction, through an abdominal approach in grade II and III achalasia, when the most important physiopathological aspects involve only the LES area (hypertonic LES or dischalasia). We extend the myotomy from the LES up to the aortic arch through a thoracic approach.
The Number of Interstitial Cells of Cajal Differs Among Different Subtypes of Achalasia and is Related to Patients' Prognosis. [2023]Achalasia is a primary esophageal motility disorder with heterogeneous manometric subtypes and prognosis, characterized by degeneration of the esophageal myenteric plexus, and reduction in interstitial cells of Cajal (ICCs). This study aimed to explore the histopathologic characteristics of lower esophageal sphincter (LES) muscle from patients with achalasia with different subtypes and different prognosis.
Full-layer mucosal histology in achalasia: Histological epithelial wave is characteristic in "pinstripe pattern"-positive achalasia. [2018]Previously, the mucosal histology in achalasia has only been investigated using superficial biopsy or surgically resected esophageal specimens in end-stage cases. We investigated the histology of the full-layer mucosa in early and advanced achalasia.
[THE VALUE OF MUSCLE BIOPSY IN PATIENTS WITHOUT WEAKNESS, HIGH CREATINE KINASE OR MYOPATHY ON ELECTROMYOGRAPHY]. [2019]Muscle biopsy is an important diagnostic procedure for the evaluation of neuromuscular disorders, commonly employed when patients present with muscle weakness, high creatine-kinase or electromyography which suggest myopathy. The diagnostic value of this procedure when these are normal is unclear.
Combination of Symptom Profile, Endoscopic Findings, and Esophageal Mucosal Histopathology Helps to Differentiate Achalasia from Refractory Gastroesophageal Reflux Disease. [2021]Achalasia, a rare primary esophageal motility disorder, is often misdiagnosed as refractory gastroesophageal reflux disease (GERD). This study is aimed to identify the clinical and histopathologic features that may help to differentiate these two entities. Patients with untreated achalasia and those with refractory reflux symptoms despite ≥8 weeks of proton-pump inhibitor treatment were enrolled prospectively. All patients underwent validated symptom questionnaires, esophagogastroduodenoscopy with biopsy, and high-resolution impedance manometry (HRIM). Histopathology of esophageal mucosa was compared based on four pre-determined histological criteria: basal cell hyperplasia or papillae elongation, eosinophilic infiltration, petechiae formation, and hypertrophy of the muscularis mucosae (MM). Compared with the GERD patients, patients with achalasia had similar reflux symptoms, but higher Eckardt scores, fewer erosive esophagitis and hiatal hernia, more esophageal food retention on endoscopy, and higher prevalence of hypertrophy of the MM and petechiae formation on histopathology. Multivariate logistic regression based on Eckardt score ≥4, normal esophagogastric junction morphology or esophageal food retention, and coexistence of petechiae formation and hypertrophy of the MM, established the best prediction model for achalasia. Therefore, combination of routinely accessible variables, including Eckardt score, endoscopic features, and histopathology obtained via esophageal mucosal biopsy, may provide an earlier identification of achalasia.
[Muscle biopsy : Indications and techniques]. [2021]Various histological techniques were introduced for the analysis of muscle biopsy specimens in recent decades. During the 1960s, cryosections and enzyme histochemistry were established as the main techniques for evaluating muscle biopsies. Subsequently, immunohistochemistry was able to show normal components of muscle fibre, its damage, as well as accumulation or maldistribution in the presence of myopathies. In this way, structure myopathies, muscle dystrophies and inflammatory myopathies can be reliably diagnosed today. For the diagnosis of certain entities, semithin sections and electron microscopy of resin-embedded tissue, as well as molecular pathological techniques including immunoblotting and PCR are useful. To apply these and other methods optimally with the goal of achieving a diagnosis some prerequisites need to be met: a moderately affected muscle has to be chosen and a 3x1x1 cm biopsy should be taken by an experienced surgeon in an atraumatic way and transported immediately in a moist chamber to the nearest specialized laboratory. The muscle specimen is divided into four pieces, two of which are snap frozen in liquid nitrogen (one with OCT mounting medium on a cork plate, the other without mounting medium); the third piece is fixed in formalin and embedded in paraffin. The fourth is fixed in glutaraldehyde and embedded in resin. The logistical problems of a muscle biopsy need to be solved between clinicians and the analysis center prior to removal.