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Clinical Trials/CTRI/2019/06/019819
CTRI/2019/06/019819
Recruiting
未知

A randomised study comparing Endoscopic Full Thickness Plication (GERD-X) vs. Sham for esophageal abnormal acid exposure post Peroral endoscopic myotomy in patients with achalasia cardia

Endoscopy Research Foundation0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: K220- Achalasia of cardia
Sponsor
Endoscopy Research Foundation
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients of either sex aged 18\-70 years and above
  • 2\. Aachalasia cardia patients minimum 3 months post POEM with abnormal 24hr pH metry, regardless of symptoms
  • 3\. Abnormal esophageal acid exposure defined as percentage time esophageal pH less than 4 of more than 4\.2% on pH\-metry during 24\-h period while off PPI for atleast 1 week
  • 4\. Patients agreeing to informed consent

Exclusion Criteria

  • 1\. Failed POEM â?? elevated integrated relaxation pressure and lower esophageal sphincter pressure
  • 2\. Hiatus hernia hills 3 or more
  • 3\. Patients with significant renal or liver disease
  • 4\. Grade D esophagitis
  • 5\. Barrettâ??s esophagus
  • 6\. ASA physical status \>II
  • 7\. Pregnancy

Outcomes

Primary Outcomes

Not specified

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