Esophageal Achalasia Clinical Trial
Official title:
Study on the Relationship Between Different Pathological Features of Achalasia and Prognosis of Per-oral Endoscopic Myotomy
Achalasia is the most common motility disorder of esophagus, characterized by disorders of the lower esophageal sphincter (LES). Normal peristalsis of the esophagus is eliminated and replaced by synchronous or ineffective contraction. Based on high-resolution manometry (HRM), the participants with achalasia were categorized into 3 subtypes, type I: achalasia with minimum esophageal pressurization, type II: achalasia with esophageal compression and type III: achalasia with spasm. Previous studies have found that the pathological features of the esophageal muscular layers in participants with achalasia are degeneration of nerve plexus, reduction of interstitial cells of Cajal (ICCs) and infiltration of different inflammatory cells. Different subtypes of achalasia have different pathological characteristics and esophageal motility. Now, per-oral endoscopic myotomy (POEM) is a main therapy for participants with achalasia. Most studies have focused on the relationship between pathological features and motility characteristics of achalasia, but there are few studies on the relationship between pathological features and therapeutic effect of POEM. This study will prospectively collect data of participants undergoing POEM for achalasia in Beijing Friendship Hospital, including demographic data, drug and surgical treatment data during hospitalization. All participants are required to obtain esophageal muscle biopsy for pathological examination during POEM. The participants will be followed up until 12 months for improvement in clinical symptoms.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | April 16, 2024 |
Est. primary completion date | April 16, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Participants with achalasia - Age: 18 to 80 years - Accept for the treatment of POEM - Sign the informed consent Exclusion Criteria: - Participants under 18 years old - Previously received treatment of achalasia, Barrett's esophagus, esophageal stricture, liver cirrhosis, and/or esophageal varices, tumors, allergic diseases and hiatal hernia. - Use non-steroidal anti-inflammatory drugs, corticosteroids and other immunosuppressive agents. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Friendship Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Fandong Meng |
China,
Liu ZQ, Chen WF, Wang Y, Xu XY, Zeng YG, Lee Dillon D, Cheng J, Xu MD, Zhong YS, Zhang YQ, Yao LQ, Zhou PH, Li QL. Mast cell infiltration associated with loss of interstitial cells of Cajal and neuronal degeneration in achalasia. Neurogastroenterol Motil. 2019 May;31(5):e13565. doi: 10.1111/nmo.13565. Epub 2019 Mar 13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Eckardt score | Eckardt score is used to assess the severity of symptoms in participants with achalasia. The Eckardt score evaluates weight loss, dysphagia, retrosternal pain, and reflux of achalasia. The maximum value is 12 and the minimum value is 0. Higher scores mean a worse outcome. | 12months after POEM | |
Secondary | GERDQ score | GERDQ is a abbreviation of gastroesophageal reflux disease questionnaire. GERDQ score is used to assess the degree of gastroesophageal reflux after POEM. The maximum value is 18 and the minimum value is 0. Higher scores mean a worse outcome. Gastroesophageal reflux disease can be diagnosed if the GERDQ score is greater than or equal to 8. | 12months after POEM |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03962179 -
Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)
|
N/A | |
Withdrawn |
NCT02663206 -
Peroral Endoscopic Myotomy Versus Botulinum Toxin Injection in Spastic Esophageal Disorders
|
N/A | |
Active, not recruiting |
NCT00188344 -
A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia
|
N/A | |
Recruiting |
NCT04578769 -
Assessment of Different Modified POEM for Achalasia
|
N/A | |
Not yet recruiting |
NCT05010889 -
Quality of Life After POEM for Achalasia
|
||
Recruiting |
NCT02572193 -
To Assess the Feasibility of Same Day Discharge Following a POEM Procedure
|
N/A | |
Terminated |
NCT02606578 -
Achalasia Patient Reported Outcomes
|
||
Active, not recruiting |
NCT01750385 -
Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia
|
N/A | |
Active, not recruiting |
NCT03404739 -
Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia
|
Phase 2/Phase 3 | |
Completed |
NCT04112693 -
Assessment of the Neuro-glio-epithelial Unit (NGEU) in Biopsies Taken During Peroral Endoscopic Myotomy (POEM) for Achalasia: a Feasibility and Safety Study.
|
N/A | |
Recruiting |
NCT05602272 -
Respiratory and Hemodynamic Implications of Endoscopic Myotomy of the Esophagus and Stomach
|
||
Completed |
NCT02999451 -
Snare-assisted POEM for Treatment of Esophageal Achalasia
|
N/A | |
Completed |
NCT00490750 -
Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia
|
N/A | |
Recruiting |
NCT02518542 -
Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia
|
N/A | |
Recruiting |
NCT00260585 -
Esophageal Cancer Risk Registry
|
||
Recruiting |
NCT05899842 -
Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia
|
N/A | |
Completed |
NCT03702647 -
Ropivacaine For Post-POEM Pain Control
|
N/A | |
Recruiting |
NCT01637311 -
Peroral Endoscopic Remyotomy for Failed Heller Myotomy
|
N/A | |
Completed |
NCT00004416 -
Randomized Study of Botulinum Toxin Type A for Achalasia
|
N/A | |
Not yet recruiting |
NCT06027190 -
Randomized Controlled Study of Optical 3D Navigated Repetitive Transcranial Magnetic Stimulation for Achalasia.
|
N/A |