Achalasia, EGJ Outflow Obstruction
Conditions
Keywords
Novel Flexible Bipolar, POEM
Brief summary
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.
Interventions
DEVICESpydrBlade Flex
The POEM procedure will be performed using the novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK). Both anterior and posterior POEM could be performed, depending on the clinical presentation and endoscopist's preference.
Sponsors
Chinese University of Hong Kong
Academy tertiary center, IECED, Guayaquil, Ecuador
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with 18 years of age or older. * Patients referred to the participating center with a clinical indication for POEM. This includes conditions such as: achalasia, native or failed Heller myotomy, balloon dilation, and EGJ outflow obstruction. * Patients who provide informed consent.
Exclusion criteria
* Patients who have contraindications for EGD. * Patients with an Eckardt score \< 3 before POEM. * Positive diagnosis of Chagas disease. * Patients unable to withstand general anesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate | 1 day | This involves assessing the procedural success of the POEM using the novel bipolar device. Success would typically mean completing the procedure as planned, without technical difficulties or complications. Unit of measure: % of procedures |
| Clinical Success Rate | 30 days | Clinical success rate is defined as the proportion of patients in whom clinical success (as defined by an Eckardt symptom score ≤ 3) is achieved following the procedure. The Eckardt score (range 0-12) will be assessed for each patient before the procedure and at the 1 month postoperative follow-up. Clinical success for an individual patient is defined as achieving a follow-up Eckardt score of 3 or less. The clinical success rate is the percentage of patients who meet this success criterion out of the total analyzed population. Unit of measure: % of patients |
| [Safety] Incidence of intraoperative complications | 1 day | Incidence of adverse events occurring during the procedure, including: perforation, bleeding, infection, and any complications directly related to the device. Unit of measure: % of procedures |
| [Safety] Incidence of postoperative complications | 30 days | Incidence of adverse events occurring within 30 days after the procedure, including: perforation, bleeding, infection, and any complications directly related to the device. Unit of measure: % of procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Procedural Reflux - Symptom Assessment | 30 days | Reflux symptoms reported by the patient after the POEM procedure. Patient-reported symptoms tracked during follow-up visits. Unit of Measure: Presence/absence and description of symptoms (Categorical). |
| Post-Procedural Reflux - Endoscopic Features | 6 months | The presence of esophagitis features identified during endoscopic examination. Endoscopic examination performed at postoperative 6 months follow-up. Unit of Measure: Presence/absence and grading of esophagitis (Categorical). |
| Post-Procedural Reflux - pH Monitoring | 30 days | Quantitative assessment of acid reflux. A pH level below 4 for more than 6% of the monitoring period is considered indicative of significant reflux. Measured by the number of patients with significant reflux at postoperative 1 month follow-up divided by total number of patients. Unit of measure: % of patients |
| Distensibility of the Lower Esophageal Sphincter (LES) | 6 months | The distensibility of the LES, an important parameter in Achalasia treatment, will be measured using the EndoFLIP® system during the 6-month follow-up endoscopic examination. It is measured as the Distensibility Index (DI). Unit of Measure: mm²/mmHg for DI. |
| Postoperative Northwestern Esophageal Quality of Life questionnaire (NEQOL) score | 6 months | The NEQOL questionnaire, a tool designed to measure the quality of life specifically in patients with esophageal conditions, will be administered 6 months post-procedure. The NEQOL questionnaire is consisted of 14 questions answered on a 5-point Likert scale, where higher score means a better health-related quality of life (HRQOL). Unit of Measure: score (0-56) |
Countries
Ecuador, Hong Kong
Contacts
CONTACTHon Chi Yip
Outcome results
None listed