- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04878588
The Correlation Between the Barium Examination and High Resolution Impedance Manometry
The Correlation Between High Resolution Impedance Manometry and Videofluoroscopic Measurements of Swallowing Function After Patients Undergoing Esophagectomy
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients receiving elective esopagectomy
Exclusion Criteria:
- patients with major organ disease, such as heart, lung, or liver disease
- patients with coagulopathy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients receiving esophagectomy
the patients receiving esophagectomy during perioperative period.
They receive barium examination and high resolution impedance manometry at the same time
|
patients received the above two examination at the same time
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the contractility of the muscle at the upper gastrointestinal tract
Time Frame: 20 minutes
|
the contractility at the upper gastrointestinal tract muscle
|
20 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 202102001RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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