Assessment of Different Modified POEM for Achalasia

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Oct 1, 2020

Keywords

ClinConnect Summary

This clinical trial is studying different surgical methods to treat a condition called esophageal achalasia, which makes it hard for food to pass from the esophagus into the stomach. The trial aims to compare the effectiveness and safety of various types of surgical procedures known as myotomy. Specifically, it looks at traditional long and circular myotomy methods versus shorter and more tailored approaches for patients with different types of achalasia.

To be eligible for this trial, participants should be between the ages of 14 and 70, diagnosed with type I, II, or III achalasia through specific tests, and be able to give written consent. They should not have had previous surgeries for achalasia or certain other medical conditions that could complicate the procedure. If you join the study, you will receive one of these surgical treatments and be monitored for how well it works and any potential side effects. This is an important opportunity to help researchers understand the best ways to treat achalasia and improve care for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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