Clinical trial NCT05157984: Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum
Official title: Evaluation of Peroral Endoscopic Myotomy to Treat Zenker's Diverticulum
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Zenker Diverticulum
Keywords: Zenker's Diverticulum
peroral endoscopic myotomy
Lead sponsor: Methodist Health System
Sponsor class: OTHER
Collaborators: name: Baylor Scott and White Health
First posted: 2021-12-15
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Zenker's diverticulum (ZD) and who have undergone the ZPOEM procedure, as well as patients who will have this procedure in the future

Brief summary: This is a multicenter investigator-initiated trial between Baylor-Scotts \& White (BSW) and Methodist Health System (MHS). This study will be conducted via a retrospective review and a prospective patient registry. Patients who have undergone the ZPOEM procedure performed by the physicians listed in this protocol will be included, as well as patients who will have this procedure in the future. Data that will be collected at MHS will be entered into an Excel spreadsheet. Patient demographic information will be collected via a review of subjects' electronic medical records. Available patient outcomes will be collected via a review of electronic medical records. This review will be conducted from 1/1/2017 through 12/31/2025.

Detailed description: This is a multicenter investigator-initiated trial between Baylor-Scotts \& White (BSW) and Methodist Health System (MHS). This study will be conducted via a retrospective review and a prospective patient registry. Patients who have undergone the ZPOEM procedure performed by the physicians listed in this protocol will be included, as well as patients who will have this procedure in the future. Data that will be collected at MHS will be entered into an Excel spreadsheet. Patient demographic information will be collected via a review of subjects' electronic medical records. Available patient outcomes will be collected via a review of electronic medical records. This review will be conducted from 1/1/2017 through 12/31/2025.

To obtain the follow-up information, potential subjects will be identified using the same process described in the previous paragraph and will be contacted by a member of the institution's research team to answer questions about their symptoms post-surgery. These are listed in the ZPOEM Data Collection Sheet. These questions may be administered over the phone, via email, or by mail. Subjects enrolled in the patient registry will have follow-up data collected at 2-time points: 2 weeks post-op and 3 months post-op.

Primary endpoints and other variables to be collected are those listed on the ZPOEM Data Collection Sheet. Primary subject endpoints include, but are not limited to:

* Dysphagia score(s) - depending on what is available in EMR
* Weight gain following surgery

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Any patient of the physicians listed in this study who has undergone the ZPOEM procedure to treat ZD at MHS
* For prospective registry: Ability to give informed consent

Exclusion Criteria:

* For prospective registry: Unable or not willing to provide informed consent

Primary outcomes:
measure: Retrospective chart review / Compartive analyses; t-tests and Wilcoxon-Mann-Whiteney Test; Chi-square or Fisher's exact test; and Pearson correlation coeffecient or Spearman's rank-order correlation
timeFrame: January 2017 to December 2025
Secondary outcomes:
measure: Prospective follow-up of patients/ Compartive analyses; t-tests and Wilcoxon-Mann-Whiteney Test; Chi-square or Fisher's exact test; and Pearson correlation coeffecient or Spearman's rank-order correlation
timeFrame: June 2021 to December 2025
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Prashant Kedia, MD
role: PRINCIPAL_INVESTIGATOR
References: