Peroral Endoscopic Myotomy for the Treatment of Achalasia

Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Single-center Registry

There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019 & a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021

Study Overview

• Status: Recruiting
• Conditions: Achalasia
• Intervention / Treatment: Procedure: Endoscopic procedure for achalasia

Detailed Description

Subjects will undergo no additional tests and procedures as part of this study. All data will be collected from patient's electronic health records (EHR) of the hospital In addition; a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021. All the subjects enrolled in prospective chart review will be first consented for their study participation. Subjects will undergo a clinically indicated endoscopic procedure and POEM and subsequent follow-up clinical visits as part of their standard medical care. All procedures, barring research activities such as consenting and data collection from Electronic Health Records, will be either clinically indicated and/or standard of care.

• Each patient in the study will be assigned a Case ID number to de-identify their personal health information during data collection
• The Case ID number connecting the patient to the personal health information will be in an encrypted electronic file on a computer that can only be accessed by study members at MDMC.
• A procedure report and outpatient clinical records for each subject's POEM procedure will be used to record each patient's data for the registry
• That data will only be shared by members of the study (PIs, research coordinator) who require it for conducting of data collection/interpretation

"Disclaimer: Any cost associated with the procedures stated herein will be billed directly to you or to your insurance (as applicable)."

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Zaid Haddadin, MS; Phone Number: 214-947-4604; Email: clinicalresearch@mhd.com
• Study Contact Backup: Name: Crystee Cooper, DHEd; Phone Number: 214-947-1280; Email: clinicalresearch@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center
      • Contact: Prashant Kedia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

There will be a retrospective chart review for patients who underwent endoscopic procedures and POEM from 06/2016 - 01/2019. In addition; a prospective chart review will be performed for patients who will undergo endoscopic procedures and POEM from 02/2019 - 06/2021.

Description

Inclusion Criteria:

• Any discharged patient who has undergone clinically indicated and/or standard of care POEM for the treatment of Achalasia from 6/2016 to 6/2021.
• Above or equal to 18 years of age

Exclusion Criteria:

• Any patient who has not undergone POEM for the treatment of Achalasia.
• Below 18 years of age

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease or no symptoms of chest pain	To continue and review our treatment outcomes, patient safety in cases with achalasia, we follow up after the procedure up to 180 days. Follow-up period varies from patient to patient.	upto 180 days

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Prashant Kedia, M.D., Methodist Dallas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Estimated): February 5, 2024
• Study Completion (Estimated): February 5, 2024

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: 031.GID.2018.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No