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Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After ARS in Patients With GERD

Sponsor
Shandong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05380791
Collaborator
(none)
70
Enrollment
1
Location
49.3
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

rapid swallow (MRS) can assess the contractile reserve capacity of the oesophageal body and identify and diagnose oesophageal motility disorders, but the impact of preoperative oesophageal reserve capacity on postoperative symptoms and motility in patients with GERD remains unclear. The aim of this study was to assess the effect of pre-operative oesophageal reserve capacity on post-reflux symptoms and motility in patients with GERD by using a high-resolution oesophageal manometry-based provocation test, MRS, to track pre-operative ineffective oesophageal motility (IEM).

Condition or Disease Intervention/Treatment Phase
  • Other: Follow-up visits

Detailed Description

Lower oesophageal sphincter relaxation is an important cause of GERD and ineffective oesophageal motility may be associated with GERD, but the mechanism of oesophageal corporal motility disorders is unclear. High-resolution manometry (HRM) has shown to be more accurate than conventional manometry in assessing oesophageal motility, and can provide guidance for GERD surgery. The aim was to conduct a cohort study to investigate the yu'h of patients with preoperative esophageal motility disorders with or without esophageal reserve, based on the assessment of esophageal motility by high-resolution esophageal manometry to follow up changes in esophageal motility and symptoms in patients after anti-reflux surgery.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
70 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After Anti-reflux Surgery in Patients With Gastroesophageal Reflux Disease
Actual Study Start Date :
Apr 22, 2022
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
IEM in patients with GERD with normal MRS contraction

Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests

Other: Follow-up visits
Regular follow-up visits to record information about the patient's surgery and routine post-operative examinations
Other Names:
  • Questionnaire to assess symptoms and quality of life etc.

    		•
    IEM in patients with GERD with abnormal MRS contraction

    Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests

    Other: Follow-up visits
    Regular follow-up visits to record information about the patient's surgery and routine post-operative examinations
    Other Names:
  • Questionnaire to assess symptoms and quality of life etc.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effect of changes in oesophageal motility after anti-reflux surgery compared to pre-surgery [2 year follow-up after anti-reflux surgery]

      Using high resolution manometry to assess changes in oesophageal motility after anti-reflux surgery, compared to pre-surgery.

    Secondary Outcome Measures

    1. Effect of changes of post-anti-reflux surgery symptoms [2 year follow-up after anti-reflux surgery]

      Reflux Symptom Questionnaire Assessment to assess the changes of symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age over 18 years old

    • Patients to be treated surgically for gastroesophageal reflux disease

    • Ineffective esophageal motility diagnosed by high resolution esophageal manometry according to Chicago Classification version 4.0

    • Obtaining Informed Consent

    Exclusion Criteria:

    • Previous other upper gastrointestinal surgery

    • Pregnant women and other people with contraindications to surgery and tests

    • Other specifically defined esophageal motility disorders, such as nutcracker esophagus

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gastroenterology, Qilu Hospital, Shandong University Jinan Shandong China 250012

    Sponsors and Collaborators

    • Shandong University

    Investigators

    • Study Chair: Yanqing Li, phD, Qilu Hospital of Shandong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yanqing Li, Vice-President, Shandong University
    ClinicalTrials.gov Identifier:
    NCT05380791
    Other Study ID Numbers:
    • 2022-SDU-QILU-008
    First Posted:
    May 19, 2022
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yanqing Li, Vice-President, Shandong University
    contraction reserve
    Additional relevant MeSH terms:
    Esophageal Motility Disorders
    Esophageal Spasm, Diffuse

    Study Results

    No Results Posted as of May 19, 2022