The Correlation Between the Barium Examination and High Resolution Impedance Manometry

September 6, 2021 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

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

Observational

Enrollment (Anticipated)

20

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients receiving elective esophagectomy

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: patients received high resolution impedance manometry
patients received the above two examination at the same time
Other Names:
  • patients received barium examination

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

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 6, 2021

Primary Completion (Anticipated)

May 10, 2025

Study Completion (Anticipated)

May 10, 2027

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

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)?

NO

IPD Plan Description

due to ethical issue

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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