Clinical Trial: Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Different Surgical Procedures of Peroral Endoscopic Myotomy(POEM) for Esophageal Achalasia: a Multicenter Prospective Randomized Controlled Trial

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 Summary:

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 ≥
Sponsor: Nanfang Hospital of Southern Medical University

Current Primary Outcome: Therapeutic success [ Time Frame: 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.)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Procedure related complication [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Nanfang Hospital of Southern Medical University

Dates:
Date Received: January 5, 2017
Date Started: December 2016
Date Completion: December 2021
Last Updated: May 11, 2017
Last Verified: May 2017