the Correlation Between the Barium Examination and High Resolution Impedance ManometryNCT04878588
The Correlation Between the Barium Examination and High Resolution Impedance Manometry
An observational study of the Correlation Between the Barium Examination and High Resolution Impedance Manometry, run by National Taiwan University Hospital.
Trial summary
In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- the Correlation Between the Barium Examination and High Resolution Impedance Manometry
- What is being tested?
- patients received high resolution impedance manometry
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2021to 10 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- Adult, Older adult
Study population: patients receiving elective esophagectomy
Who may be able to join
- patients receiving elective esopagectomy
Who cannot join
- patients with major organ disease, such as heart, lung, or liver disease
- patients with coagulopathy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Correlation Between High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function After Patients Undergoing Esophagectomy
In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive. In this study, we aimed to examine the correlation between high-resolution manometric and videofluoroscopic (Barium) measurements of the swallowing function.
Read the detailed description
In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry (HRIM) could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive.
In this study, we aimed to examine the correlation between high-resolution manometric and videofluoroscopic (Barium) measurements of the swallowing function.
For the patients and method decription, consecutive patients who will fulfill the criteria of elective esophagectomy patients aged >= 20 will be enrolled. After got the inform consent, these patients receive the swallowing function by barium examination and HRIM.
- Being tested
- patients received high resolution impedance manometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients received high resolution impedance manometryOther
Also called patients received barium examination
patients received the above two examination at the same time
| Study group | Role | What they receive |
|---|---|---|
| patients receiving esophagectomy | the patients receiving esophagectomy during perioperative period. They receive barium examination and high resolution impedance manometry at the same time Receives: Other: patients received high resolution impedance manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
the contractility of the muscle at the upper gastrointestinal tract
the contractility at the upper gastrointestinal tract muscle
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start6 Sep 2021 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Correlation Between the Barium Examination and High Resolution Impedance ManometryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878588
- Sponsor's protocol ID
- 202102001RIND
- Status last verified
- Sep 2021
- First submitted
- 4 May 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to ethical issue
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function After Patients Undergoing Esophagectomy
- ClinicalTrials.gov ID
- NCT04878588
- Acronym / sponsor ID
- 202102001RIND
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Sep 2021 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 7 May 2021 (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.
In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive. In this study, we aimed to examine the correlation between high-resolution manometric and videofluoroscopic (Barium) measurements of the swallowing function.
Detailed description
In many cases, the manometric examination is not feasible because of the pharyngeal sinusitis or pharyngeal torsion. In addition, although previous conventional manometry was used to estimate pharyngeal swallowing, the bolus flow transmission was still not evaluated, which still depended on the videofluoscopic swallowing studies. High resolution impedance manometry (HRIM) could help us to measure the bolus flow according to the impedance changes. However, the comparison between two approach methods of postoperative recovery of swallowing function is still inconclusive.
In this study, we aimed to examine the correlation between high-resolution manometric and videofluoroscopic (Barium) measurements of the swallowing function.
For the patients and method decription, consecutive patients who will fulfill the criteria of elective esophagectomy patients aged >= 20 will be enrolled. After got the inform consent, these patients receive the swallowing function by barium examination and HRIM.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients receiving esophagectomy | – | Other: patients received high resolution impedance manometrythe patients receiving esophagectomy during perioperative period. They receive barium examination and high resolution impedance manometry at the same time |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients receiving elective esophagectomy
Key inclusion criteria (1 listed)
- patients receiving elective esopagectomy
Key exclusion criteria (2 listed)
- patients with major organ disease, such as heart, lung, or liver disease
- patients with coagulopathy
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 |
|---|---|---|
| patients received high resolution impedance manometryAlso: patients received barium examinationpatients received the above two examination at the same time | Other | patients receiving esophagectomy |
Primary outcome
the contractility of the muscle at the upper gastrointestinal tract
Time frame: 20 minutes
the contractility at the upper gastrointestinal tract muscle
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No. due to ethical issue
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.
Questions about this trial
What is this clinical trial studying?
An observational study of the Correlation Between the Barium Examination and High Resolution Impedance Manometry, run by National Taiwan University Hospital.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chih-Jun Lai, MD (0223123456 ext. 62158, littlecherrytw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the contractility of the muscle at the upper gastrointestinal tract (time frame: 20 minutes). 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 14 Sep 2021; AzTrials last refreshed its copy on 31 Oct 2026.