Esophageal Achalasia
Conditions
Keywords
peroral endoscopic myotomy, Achalasia, thickness of myotomy
Brief summary
The aims of this study is to compare the efficacy and safety of conventional myotomy (circular myotomy) and modified myotomy (full-thickness myotomy) in the treatment of achalasia patients.
Detailed description
Peroral endoscopic myotomy (POEM) is a novel clinical technique used to treat achalasia. The conventional POEM myotomy length averages 8 to 10 cm (4-6 cm in the esophagus, 2-4cm in the LES, 2cm in the cardia & 6-8 cm above and 2 cm below the gastroesophageal junction \[GEJ\]) for typical achalasia (Chicago classification I, II), with only the inner circular muscle layer incised. There is still no conclusion on the thickness of muscle bundle dissection recommended during POEM. Selective circular muscle myotomy is designed to avoid gastroesophageal reflux (GER) postoperatively and decrease morbidity during POEM. But one meta-analysis showed that Heller's surgery could keep patients in long-time remission, mainly because of its full-thickness muscle bundle dissection to make sure of persist relaxation of LES. A retrospective study comparing the outcomes of full-thickness and circular muscle myotomy showed no differences in efficacy, GER or adverse events, although the procedural time was shorter in the full thickness myotomy group. Further randomized controlled trials are warranted to assess the efficacy and safety of different modified myotomy approaches in POEM for patients with achalasia.
Interventions
PROCEDUREconventional myotomy
1. Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ. 3. Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 2 cm distal to the GEJ. 4. Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips.
PROCEDUREfull-thickness myotomy
1. Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ). 2. Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ. 3. Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 4 cm proximal to the GEJ, and a full-thickness muscle myotomy is continually carried out from 4cm proximal to the GEJ down to 2 cm distal to the GEJ. 4. Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed as achalasia type I or II according to the Chicago Classification Version 4.0, with an Eckardt score \>3 * Their age is ≥14years and ≤70 years * Able to give written consent
Exclusion criteria
* undergone previous surgical treatments * had contra-indication to general anesthesia * previous surgery of the mediastinum, stomach, or esophagus; * Pregnant or lactating female * type III achalasia * current alcohol or drug addiction, mental retardation, severe congenital or acquired coagulopathy (international normalized ratio \>1.6) * hepatic cirrhosis with or without portal hypertension, eosinophilic esophagitis (biopsies were performed at index endoscopy), or confirmed Barrett's esophagus * esophageal diverticula or hiatal hernia based on findings from the index barium esophagram, or other conditions that the investigator believed not appropriate for POEM procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic success of short term | 6 months after the procedure | Clinical severity was assessed using the Eckardt score. This score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with 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). The total score ranges from 0 to 12, with higher scores indicating more severe disease symptomatology. (Eckardt, V. Gastroenterology, 1992. 103(6): 1732-8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | During the endoscopic procedure | The duration of the endoscopic procedures for each patients will be calculated, in minutes, since the mucosal incision until the endoscopic closure of the mucosal entry with the last endoscopic clip. |
| Pressure changes by high-resolution manometry (HRM) | 6 month after the procedure | Basal lower esophageal sphincter (LES) pressure, Distal contractile integral (DCI) and integrated relaxation pressure (IRP) |
| barium esophagogram | 6 month after the procedure | Barium swallow studies will be done to evaluate the oesophageal emptying at 5 minutes and esophageal distortion |
| Rate of intra-procedure complications | During the endoscopic procedure | Complications encountered during the procedure will be noted. (perforation, delayed bleeding, pneumothorax, subcutaneous emphysema, anastomotic leak etc.) |
| the rate and severity of oesophagitis | 6 months after the procedure | oesphagitis was identified under esophagogastroduodenoscopy, and was classified according to the Los Angeles Classification |
| (4) Esophagogastroduodenoscopy (EGD) with the novel Endoscopic Scoring for Achalasia (CARS) | 6-month after the procedure | Endoscopic evaluation was performed using the Contents, Anatomy, Resistance, and Stasis (CARS) score. This scoring system was developed and validated through video-based reliability assessments and initially demonstrated strong clinical utility for predicting achalasia. The score assigns 0 to 2 points each for Contents, Anatomy, and Resistance at the lower esophageal sphincter, and 1 point for each component of Stasis. The total score ranges from 0 to 8, with higher scores indicating a worse endoscopic outcome. |
| POEM difficulty evaluation | During the endoscopic procedure | ① Peroral Endoscopic Myotomy (POEM) difficulty score (PDS). The score consists of five variables: Fibrosis, Oozing, Orientation, Distension of tunnel, and Spastic contractions ("FOODS"). Each variable was arbitrarily weighted equally and assigned values ranging from 0 to 2. The PDS was completed immediately post-procedure in the operating room. The total score ranges from 0 to 10, with higher scores indicating greater technical difficulty. ② bleeding episodes, classified into (1) none to minimal (2) moderate to diffuse |
| perioperative hospitalization | perioperative period | perioperative hospitalization length |
| post-POEM persistent pain | postoperative period | Post-POEM persistent pain was defined as pain requiring level 2 or 3 analgesics. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORTao Guo, MD
Peking Union Medical College Hospital
Outcome results
None listed