Achalasia Cardia
Conditions
Keywords
Achalasia, POEM, Pneumatic dilatation, Eckardt score
Brief summary
The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.
Detailed description
Achalasia is an esophageal motility disorder which involves smooth muscle of the esophagus and the lower esophageal sphincter (LES). Achalasia causes difficulty swallowing, regurgitation, and sometimes chest pain and weight loss. Endoscopic treatments of achalasia can be provided in the form of dilatation of the LES or cutting of muscle fibers (myotomy) of the esophagus and of the LES under endoscopic viewing. Dilatation in this trial is accomplished with rigiflex balloons and myotomy via Per Oral Endoscopic Myotomy (POEM). The effectiveness of treatment of achalasia using each method will be compared in this trial.
Interventions
PROCEDUREPer Oral Endoscopic Myotomy (POEM)
* Mucosal incision - After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 12 cm proximal to the gastroesophageal junction (GEJ). * Submucosal tunneling. A long submucosal tunnel is created to 3 cm distal to the GEJ. * Endoscopic myotomy is begun at 3 cm distal to the mucosal entry point, and is carried out in a proximal to distal direction to a total length of 10 cm. * Long endoscopic myotomy is performed 10 cm proximal to GEJ extending * Closure of mucosal entry: the mucosal incision is closed using hemostatic clips
PROCEDUREPneumatic Dilatation
Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Achalasia with Eckardt score at least 3 (0-12 scale achalasia least-most severe) 2. Age 18-75 years 3. Willing and able to comply with the study procedures and provide written informed consent form to participate in the study written informed consent form to participate in the study
Exclusion criteria
1. Severe comorbid illness 2. Previous esophageal or gastric surgery 3. Pseudo achalasia 4. Achalasia with esophageal diverticula 5. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success | 3 months post procedure | Clinical success defined as reduction of Eckardt score (0-12 scale achalasia least-most severe) of achalasia to an Eckardt score of 3 or less post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 1 week post procedure | All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 3, 6 and 12 months post procedure | Quality of Life (QOL) improvement at 3, 6 and 12 months post procedure compared to baseline using SF36 questionnaire |
| Cytokine levels | Pre procedure and immediately and 6 hours post procedure | Post procedural inflammation compared to baseline as measured by blood cytokine levels |
| Long term clinical success | 6 and 12 months post procedure | Long term clinical success at 6 and 12 months post procedure compared to baseline. |
| LES pressure | 3, 6 and12 months post procedure | Post procedure reduction in LES pressure at 3, 6 and 12 months compared to baseline. |
Countries
India
Contacts
Primary ContactD Nageshwar Reddy, MD
Outcome results
None listed