Assessment of Different Modified POEM for Achalasia
- Conditions
- Esophageal Achalasia
- Interventions
- Procedure: conventional myotomyProcedure: short myotomyProcedure: full-thickness myotomyProcedure: tailored myotomy
- Registration Number
- NCT04578769
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
The aims of this study are 1) to compare the efficacy and safety of conventional myotomy (long myotomy) and modified myotomy (short myotomy) in the treatment of type I/II achalasia patients diagnosed according to Chicago Classification; 2) to compare the efficacy and safety of conventional myotomy (circular myotomy) and modified myotomy (full-thickness myotomy) in the treatment of type I/II achalasia patients; 3) to compare the efficacy and safety of conventional myotomy (non-tailored myotomy) and modified myotomy (tailored myotomy) in the treatment of type III 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), but there is no guideline or expert consensus with regard to minimal myotomy length recommended in POEM.
Based on the facts that achalasia is a primary motor disorder of LES dysfunction, patients with type I/II achalasia may achieve a satisfactory outcome with shorter myotomy in procedure of modified POEM, which only focused on the forced relaxation of the LES. Recently, some retrospective studies have suggested that shorter myotomy is comparable with longer myotomy for treating achalasia with regard to clinical efficacy and has the advantage of shorter procedure time, which needs to be further confirmed by more prospective studies.
In terms with the International Peroral Endoscopic Myotomy Survey, a longer myotomy is recommended for patients with type III achalasia. The length of myotomy in type III achalasia can be gauged by high-resolution manometry (HRM). Recent research showed that postoperative Eckardt score was significantly improved in the tailored group (myotomy length informed by HRM) versus non-tailored for type III achalasia, but this study was limited by its retrospective nature.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 325
- Subjects diagnosed as achalasia type I, II, or III on the basis of the results of established methods (barium swallow, manometry, esophagogastroduodenoscopy)
- Candidate for a POEM
- No contra-indication to general anesthesia
- Their age is ≥14years and ≤70 years
- Able to give written consent
- Previous myotomy for achalasia: any of previous Heller myotomy, endoscopic myotomy
- Previous mediastinal surgery
- Any anatomical esophageal anomaly that in the opinion of the investigator may render the intervention more difficult, such as sigmoid esophagus on the pre-operative barium swallow, esophageal diverticula or hiatal hernia.
- Any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure
- Pregnant or lactating female
- Subjects with coagulopathy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description conventional myotomy conventional myotomy conventional myotomy for achalasia type I, II and III short myotomy short myotomy modified myotomy (short myotomy) for achalasia type I and II full-thickness myotomy full-thickness myotomy modified myotomy (full-thickness myotomy) for achalasia type I and II tailored myotomy tailored myotomy modified myotomy (tailored myotomy) for achalasia type III
- Primary Outcome Measures
Name Time Method 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.)
Therapeutic success of short term 6 months after the procedure Therapeutic success is defined as a reduction in the Eckardt score to ≤3. 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): 1732-8.
Rate of GERD 2 years after the procedure Gastro-esophageal reflux disease (GERD) is identified by positive results of esophageal pH-impedance/pH-monitoring (DeMeester score), gastro-esophageal reflux symptom assessment (GerdQ questionnaire) or esophagogastroduodenoscopy (reflux esophagitis).
Therapeutic success of long term 2 years after the procedure Therapeutic success is defined as a reduction in the Eckardt score to ≤3.
- Secondary Outcome Measures
Name Time Method Pressure changes by high-resolution manometry (HRM) 2 years after the procedure Basal lower esophageal sphincter (LES) pressure and integrated relaxation pressure (IRP)
Change in barium column height by barium esophagogram 2 years after the procedure Barium swallow studies will be done to evaluate the oesophageal emptying at 5 minutes
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.
Trial Locations
- Locations (1)
Department of Gastroenterology, Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China