Esophageal Motility DisordersNCT05380791
Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After ARS in Patients With GERD
An observational study of Esophageal Motility Disorders, run by Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Motility Disorders
- What is being tested?
- Follow-up visits
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2022to 1 Jun 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients to be treated surgically for gastroesophageal reflux disease. Ineffective esophageal motility diagnosed by high resolution esophageal according to Chicago Classification version 4.0(defined as ≥ 70% of swallows with weak contraction (distal contraction interval (DCI) between 100mmHg/s/cm and less than 450 mmHg/s/cm) or ≥ 50% of swallows with failed peristalsis Performance.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Yanqing Li, PhD. MD., 18678827666, liyanqing@sdu.edu.cn
About this study
Official title: Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After Anti-reflux Surgery in Patients With Gastroesophageal Reflux Disease
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).
Read the 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.
- Conditions
- Esophageal Motility Disorders
- Being tested
- Follow-up visits
- Keywords
- contraction reserve
- Medical subject headings
- Esophageal Motility Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up visitsOther
Also called Questionnaire to assess symptoms and quality of life etc.
Regular follow-up visits to record information about the patient's surgery and routine post-operative examinations
| Study group | Role | What they receive |
|---|---|---|
| IEM in patients with GERD with normal MRS contraction | Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests Receives: Other: Follow-up visits | |
| IEM in patients with GERD with abnormal MRS contraction | Esophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests Receives: Other: Follow-up visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of changes in oesophageal motility after anti-reflux surgery compared to pre-surgery
Using high resolution manometry to assess changes in oesophageal motility after anti-reflux surgery, compared to pre-surgery.
Measured: 2 year follow-up after anti-reflux surgery
Secondary outcomes (1)
Effect of changes of post-anti-reflux surgery symptoms
Reflux Symptom Questionnaire Assessment to assess the changes of symptoms
Measured: 2 year follow-up after anti-reflux surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start22 Apr 2022
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Motility DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, phD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380791
- Sponsor's protocol ID
- 2022-SDU-QILU-008
- Status last verified
- May 2022
- First submitted
- 21 Apr 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Esophageal Contractile Reserve on Changes in Esophageal Motility and Symptoms After Anti-reflux Surgery in Patients With Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT05380791
- Acronym / sponsor ID
- 2022-SDU-QILU-008
- Conditions
- Esophageal Motility Disorders
- Keywords
- contraction reserve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IEM in patients with GERD with normal MRS contraction | – | Other: Follow-up visitsEsophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests |
| IEM in patients with GERD with abnormal MRS contraction | – | Other: Follow-up visitsEsophageal motility determined by high resolution esophageal manometry and multiple rapid swallow (MRS) tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients to be treated surgically for gastroesophageal reflux disease. Ineffective esophageal motility diagnosed by high resolution esophageal according to Chicago Classification version 4.0(defined as ≥ 70% of swallows with weak contraction (distal contraction interval (DCI) between 100mmHg/s/cm and less than 450 mmHg/s/cm) or ≥ 50% of swallows with failed peristalsis Performance.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up visitsAlso: Questionnaire to assess symptoms and quality of life etc.Regular follow-up visits to record information about the patient's surgery and routine post-operative examinations | Other | IEM in patients with GERD with abnormal MRS contraction, IEM in patients with GERD with normal MRS contraction |
Primary outcome
Effect of changes in oesophageal motility after anti-reflux surgery compared to pre-surgery
Time frame: 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.
1 secondary outcome
Effect of changes of post-anti-reflux surgery symptoms
Time frame: 2 year follow-up after anti-reflux surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqing Li, phD study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Motility Disorders, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact FeiXue Chen, MD (18560086108, qlxhkqz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of changes in oesophageal motility after anti-reflux surgery compared to pre-surgery (time frame: 2 year follow-up after anti-reflux surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.