Esophageal Achalasia
Conditions
Keywords
Esophageal Achalasia,, Peroral endoscopic myotomy,, Water-jet assisted
Brief summary
Peroral endoscopic myotomy (POEM) has recently been introduced as promising alternative to laparoscopic Heller myotomy for patients with idiopathic achalasia. Several technical modifications have been proposed but have not yet been tested in randomized trials.
Detailed description
Objective: To evaluate efficacy and safety of water-jet assisted POEM (WJ) versus the conventional technique (C). Interventions: Patients with achalasia diagnosed by symptoms, endoscopy and barium swallow eligible for POEM were randomized to either the use of Erbe Hybrid knife (WJ group) or the conventional technique using injection and triangle tip knife interchangeably (C group). Main outcome measurements: Procedure time in both groups; secondary outcomes were clinical efficacy and safety (bleeding complications, pneumothorax or pleural effusion requiring intervention)
Interventions
PROCEDUREWater-jet POEM
Water-jet assisted POEM procedure was performed
PROCEDUREConventional POEM
POEM were performed by the use of conventional technique using injection and triangle tip knife.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* With an Eckardt symptom score ≥ 4 * The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy) * Informed patient consent was obtained
Exclusion criteria
* Severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk * Pseudoachalasia * Megaesophagus (diameter of \> 7 cm)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure time in both groups | during POEM procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical efficacy and safety | during hospital stay and up to 1 year | bleeding complications, pneumothorax or pleural effusion requiring intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic success | Every 3 months after innitial intervention via telephone questionnaires during follow-up up to 1 year | a reduction in the Eckardt score to ≤3 |
Countries
China
Contacts
Primary ContactPing-Hong Zhou, M.D, PhD
Outcome results
None listed