Achalasia, Postoperative Complications
Conditions
Keywords
achalasia, peroral endoscopic myotomy, LES pressure, postoperative complication, symptom relief, esophageal barium
Brief summary
Achalasia is a rare esophageal motility disorder, characterized by incomplete lower esophageal sphincter relaxation, increased Lower esophageal sphincter (LES) tone, and aperistalsis of the esophagus. Typical clinical symptoms are dysphagia,regurgitation and chest pain. Traditional treatments include endoscopic balloon dilatation or botulinum toxin injection, laparoscopic Heller myotomy with or without a partial fundoplication. Peroral endoscopic myotomy (POEM) has been developed as a further endoscopic effective and minimal invasive treatment. The aim of this study is to investigate the efficacy and safety of POEM in our department, and to assess short-term and long-term efficacy of POEM by using Stooler score, Echardt score, esophageal barium and manometry.
Interventions
PROCEDUREperoral endoscopic myotomy
A 3-cm incision is made into the mucosa after injection of saline and methylene blue. A submucosal tunnel is created from the mid-esophagus to the gastric cardia by a triangle-tip knife. The circular muscle fibers or full-thickness muscle are divided by the triangle-tip knife over a length of 6-20 cm on the esophagus, starting 3 cm below the initial mucosal incision, and extended 3-4cm onto the gastric cardia. The mucosal entry site is closed using standard endoscopic clips at last.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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 diagnosed as achalasia according to symptoms, esophageal barium,manometry and esophagogastroduodenoscopy * Age over 18 years old * Signed written informed consent
Exclusion criteria
* Patients with previous surgery of the stomach or esophagus * With known coagulopathy * Active esophagitis,eosinophilic esophagitis or Barrett's esophagus * Pregnancy * Stricture of the esophagus * Hiatal hernia \> 2cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| symptom relief | 1-12months | compare patients' symptoms before and after POEM at 1 month, 12 months. |
| Lower esophageal sphincter pressure | 1-12months | compare patients's lower esophageal sphincter pressure before and after POEM at 1 month,12 months. |
| improvement of esophageal barium | 1-12 months | compare esophageal barium before and after POEM at 1 months,12 months |
| Postoperative complications | 0-12months | postoperative complications |
Countries
China
Outcome results
None listed