Assessment of Different Modified POEM for Achalasia
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|ClinicalTrials.gov Identifier: NCT04578769|
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Achalasia||Procedure: conventional myotomy Procedure: short myotomy Procedure: full-thickness myotomy Procedure: tailored myotomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||325 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison Study of Conventional Peroral Endoscopic Myotomy (POEM) and Different Modified Procedures of POEM for Achalasia|
|Actual Study Start Date :||September 2, 2020|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2027|
Active Comparator: conventional myotomy
conventional myotomy for achalasia type I, II and III
Procedure: conventional myotomy
Experimental: short myotomy
modified myotomy (short myotomy) for achalasia type I and II
Procedure: short myotomy
Other Name: modified myotomy
Experimental: full-thickness myotomy
modified myotomy (full-thickness myotomy) for achalasia type I and II
Procedure: full-thickness myotomy
Other Name: modified myotomy
Experimental: tailored myotomy
modified myotomy (tailored myotomy) for achalasia type III
Procedure: tailored myotomy
Other Name: modified myotomy
- Therapeutic success of short term [ Time Frame: 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.
- Therapeutic success of long term [ Time Frame: 2 years after the procedure ]Therapeutic success is defined as a reduction in the Eckardt score to ≤3.
- Rate of intra-procedure complications [ Time Frame: During the endoscopic procedure ]Complications encountered during the procedure will be noted. (perforation, delayed bleeding, pneumothorax, subcutaneous emphysema, anastomotic leak etc.)
- Rate of GERD [ Time Frame: 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).
- Procedure time [ Time Frame: 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) [ Time Frame: 2 years after the procedure ]Basal lower esophageal sphincter (LES) pressure and integrated relaxation pressure (IRP)
- Change in barium column height by barium esophagogram [ Time Frame: 2 years after the procedure ]Barium swallow studies will be done to evaluate the oesophageal emptying at 5 minutes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04578769
|Contact: Tao Guo, MDfirstname.lastname@example.org|
|Department of Gastroenterology, Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Tao Guo, MD 8610-69155017 email@example.com|
|Principal Investigator: Tao Guo, MD|
|Principal Investigator:||Tao Guo, MD||Peking Union Medical College Hospital|