Esophageal Achalasia, Esophageal Motility Disorders
Conditions
Keywords
Esophageal achalasia, Peroral endoscopic myotomy, POEM
Brief summary
This study compares the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.
Detailed description
Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food. Currently, treatment options mainly focus on relief of the symptoms by reducing the LES pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia. However, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM) combined with Dor's antireflux procedure has gained considerable interest. The LHM can sustain therapeutic effects for long-term in approximately 80% of patients. Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically, POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction. However, the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients were not determined, and there was no prospective study that compared different surgical procedures of POEM for esophageal achalasia. Therefore, we aim to compare the clinical efficacy of safety of circular myotomy and full-thickness myotomy guided by peroral endoscopic in treatment of incision length of ≤7cm and of ≥7cm in achalasia patients.
Interventions
PROCEDUREshort-myotomy
1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ. 3. Endoscopic myotomy is carried out in a proximal to distal direction to a total length less than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ. 4. Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done. 5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
PROCEDURElong-myotomy
1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ. 3. Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ. 4. Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done. 5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
PROCEDUREfull-thickness myotomy
1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ. 3. Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ. 4. Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done. 5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
PROCEDUREcircular myotomy
1. Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ. 3. Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ. 4. Myotomy of inner circular muscle bundles is done, leaving the outer longitudinal muscle layer intact. 5. Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Between 18 and 75 years of age; 2. Patient with esophageal achalasia; 3. Eckardt score \> 3; 4. Signed informed consent.
Exclusion criteria
1. Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk; 2. Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in the distal oesophagus; 3. Previous endoscopic Botox injection; 4. Previous oesophageal or gastric surgery; 5. Pregnancy or lactation women, or ready to pregnant women; 6. Not capable of filling out questionnaires.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic success | From date of randomization until the follow-up ended, assessed up to 5 years | Therapeutic success is defined as a symptom control to an Eckardt score of 3 or less. The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of \<5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of \>10 kg) (Eckardt, V. Gastroenterology, 1992. 103(6): p. 1732-8.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure related complication | From date of randomization until the follow-up ended, assessed up to 5 years | Perforation, Delayed bleeding, Pneumothorax, Subcutaneous emphysema, Anastomotic leak etc. |
| Time of treatment failure | From date of randomization until the follow-up ended, assessed up to 5 years | Time of treatment failure is defined as when the Eckardt score of patients are more than 3. |
| Pressure at the lower esophageal sphincter | From date of randomization until the follow-up ended, assessed up to 5 years | From date of randomization until the follow-up ended, assessed up to 5 years |
| Quality of life | From date of randomization until the follow-up ended, assessed up to 5 years | Patients will complete the quality-of-life questionnaires (the Medical Outcomes Study 36-Item Short-Form Health Survey, SF-36) for assessing quality of life. |
Countries
China
Contacts
Primary ContactWei Gong, Doctor
Backup ContactSilin Huang, Master
Outcome results
None listed