Barium Meal ExaminationGLAM-IIINCT07264322
Real-Time Dynamic Imaging Study of Normal Pharyngolaryngeal Structures During Barium Swallow (GLAM-III)
An observational study of Barium Meal Examination, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
The integrity and functional stability of pharyngolaryngeal anatomical structures are critical for airway management, and the dynamic changes of key structures (e.g., pyriform sinus, cricoid cartilage lamina) during swallowing directly relate to the design and clinical safety of laryngeal masks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Barium Meal Examination
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2025to 30 Dec 2025
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patient scheduled to take barium meal examination
Who may be able to join
- Aged 18-75 years;
- No history of pharyngolaryngeal surgery, trauma, or congenital malformation;
- No swallowing dysfunction, pharyngolaryngeal inflammation, or neurological diseases affecting swallowing;
- No recent use of drugs that affect muscle function (e.g., muscle relaxants, anticholinergics);
- Barium meal examination confirms unobstructed oropharyngeal-esophageal pathway;
- Normal pharyngolaryngeal anatomical structure (confirmed by preliminary imaging review);
- Scheduled to undergo routine barium meal examination at Zhejiang Cancer Hospital for clinical diagnosis.
Who cannot join
- Presence of diseases that may compress pharyngolaryngeal structures (e.g., goiter, mediastinal mass);
- Allergy to barium sulfate or other components of the barium suspension.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangling Wang
Hangzhou, Zhejiang, 310022
Jiangling Wang, Dr., +8615168373331, wangjl@zjcc.org.cn
Jiangling Wang, Dr.
About this study
Official title: Observational Imaging Study on Real-Time Dynamic Changes of Normal Pharyngolaryngeal Structures During Barium Swallow in Patients Undergoing Routine Barium Meal Examination
The integrity and functional stability of pharyngolaryngeal anatomical structures are critical for airway management, and the dynamic changes of key structures (e.g., pyriform sinus, cricoid cartilage lamina) during swallowing directly relate to the design and clinical safety of laryngeal masks. This observational study aims to investigate the real-time dynamic changes and physiological movement patterns of normal pharyngolaryngeal structures during barium swallow using routine barium meal examination imaging. The findings will provide anatomical and physiological evidence for optimizing laryngeal mask design and improving its anatomical fit with the pharynx and larynx.
Read the detailed description
After approval by the Ethics Committee of Zhejiang Cancer Hospital (Approval Number: IRB-2025-1096(IIT)), this study will be registered on ClinicalTrials.gov prior to participant enrollment. Given that the study only utilizes de-identified imaging data from routine barium meal examinations (no additional procedures or interventions for participants), informed consent is exempted as approved by the Ethics Committee. The study is planned to be conducted from August 2025 to October 2025.
Eligible participants are patients undergoing routine barium meal examinations at Zhejiang Cancer Hospital, meeting the inclusion criteria (18-75 years old, no pharyngolaryngeal surgery/trauma/congenital malformation, no swallowing dysfunction, unobstructed oropharyngeal-esophageal pathway, etc.) and excluding those with contraindications (e.g., goiter compressing pharyngolaryngeal structures, barium allergy).
Barium Swallow Examination Procedure:
All procedures follow the standard clinical protocol for barium meal examinations, with no additional radiation exposure or burden on participants:
Static Imaging (Resting State): Participants assume a standing position. A digital X-ray machine (Shimadzu Uni-vision) is used to obtain static images of the pharyngolaryngeal region, recording the baseline anatomical positions of the pyriform sinus, cricoid cartilage lamina, and esophageal inlet.
Dynamic Imaging (Swallowing State): Participants are instructed to swallow 5ml, 10ml, 20ml, and 40ml of medical barium sulfate suspension (concentration: 160-200% W/V) sequentially. During swallowing, a dynamic fluoroscopic imaging system is activated (frame rate: 15 frames/second) to continuously record the entire process of barium passing from the oropharynx through the larynx to the esophagus (each swallowing event lasts approximately 5-10 seconds). Each participant repeats the swallowing action 4-5 times, and the clearest dynamic image sequence is selected for subsequent analysis.
Data Collection and Analysis:
Image analysis software is used for frame-by-frame parsing of dynamic images. Key anatomical structures (pyriform sinus boundaries, anterior edge of the cricoid cartilage lamina, esophageal inlet center) are labeled, and coordinate positioning technology is applied to analyze the following parameters:
Displacement and angle changes of pharyngolaryngeal structures from resting state to peak swallowing phase; Preferred pathway of barium through the oropharynx (unilateral pyriform sinus, bilateral pyriform sinuses, or central region of the cricoid cartilage lamina); Retention time of barium in the pyriform sinus and its passing speed; Expansion amplitude of the pyriform sinus and displacement distance of the cricoid cartilage lamina during swallowing
- Conditions
- Barium Meal Examination
- Keywords
- Barium Swallow, Pharyngolaryngeal Dynamic Changes, Pyriform Sinus, Cricoid Cartilage Lamina, Laryngeal Mask Design
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time dynamic changes of pharyngolaryngeal structures during swallowing
Measurement of displacement distance of the cricoid cartilage lamina, expansion amplitude of the pyriform sinus, and movement trajectory of the esophageal inlet during swallowing (assessed via dynamic fluoroscopic imaging).
Measured: From the initiation of the barium swallow to the complete passage of the bolus through the upper esophageal sphincter, as assessed under videofluoroscopy (an average of 15 minutes per participant).
Secondary outcomes (1)
Proportion of participants with consistent instrument insertion pathway and barium's preferred pathway (pyriform sinus)
Analysis of the consistency between the barium's preferred pathway (pyriform sinus) and the insertion pathway of laryngeal mask-related instruments, to explain the anatomical fit differences among three laryngeal mask designs (LMA Supreme, I-gel, GMA-Tulip).
Measured: From the initiation of the barium swallow to the complete passage of the bolus through the upper esophageal sphincter, as assessed under videofluoroscopy (an average of 15 minutes per participant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start10 Sep 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barium Meal ExaminationStudies 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
- Other
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Jiangling, Zhejiang Cancer Hospital
- Investigators
- Pingbo Xu, Ph. D, Study chair, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264322
- Sponsor's protocol ID
- IRB-2025-1096（IIT）
- Acronym
- GLAM-III
- Status last verified
- Nov 2025
- First submitted
- 21 Sep 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Imaging Study on Real-Time Dynamic Changes of Normal Pharyngolaryngeal Structures During Barium Swallow in Patients Undergoing Routine Barium Meal Examination
- ClinicalTrials.gov ID
- NCT07264322
- Acronym / sponsor ID
- GLAM-III / IRB-2025-1096（IIT）
- Conditions
- Barium Meal Examination
- Keywords
- Barium Swallow, Pharyngolaryngeal Dynamic Changes, Pyriform Sinus, Cricoid Cartilage Lamina, Laryngeal Mask Design
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Dec 2025 (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.
The integrity and functional stability of pharyngolaryngeal anatomical structures are critical for airway management, and the dynamic changes of key structures (e.g., pyriform sinus, cricoid cartilage lamina) during swallowing directly relate to the design and clinical safety of laryngeal masks. This observational study aims to investigate the real-time dynamic changes and physiological movement patterns of normal pharyngolaryngeal structures during barium swallow using routine barium meal examination imaging. The findings will provide anatomical and physiological evidence for optimizing laryngeal mask design and improving its anatomical fit with the pharynx and larynx.
Detailed description
After approval by the Ethics Committee of Zhejiang Cancer Hospital (Approval Number: IRB-2025-1096(IIT)), this study will be registered on ClinicalTrials.gov prior to participant enrollment. Given that the study only utilizes de-identified imaging data from routine barium meal examinations (no additional procedures or interventions for participants), informed consent is exempted as approved by the Ethics Committee. The study is planned to be conducted from August 2025 to October 2025.
Eligible participants are patients undergoing routine barium meal examinations at Zhejiang Cancer Hospital, meeting the inclusion criteria (18-75 years old, no pharyngolaryngeal surgery/trauma/congenital malformation, no swallowing dysfunction, unobstructed oropharyngeal-esophageal pathway, etc.) and excluding those with contraindications (e.g., goiter compressing pharyngolaryngeal structures, barium allergy).
Barium Swallow Examination Procedure:
All procedures follow the standard clinical protocol for barium meal examinations, with no additional radiation exposure or burden on participants:
Static Imaging (Resting State): Participants assume a standing position. A digital X-ray machine (Shimadzu Uni-vision) is used to obtain static images of the pharyngolaryngeal region, recording the baseline anatomical positions of the pyriform sinus, cricoid cartilage lamina, and esophageal inlet.
Dynamic Imaging (Swallowing State): Participants are instructed to swallow 5ml, 10ml, 20ml, and 40ml of medical barium sulfate suspension (concentration: 160-200% W/V) sequentially. During swallowing, a dynamic fluoroscopic imaging system is activated (frame rate: 15 frames/second) to continuously record the entire process of barium passing from the oropharynx through the larynx to the esophagus (each swallowing event lasts approximately 5-10 seconds). Each participant repeats the swallowing action 4-5 times, and the clearest dynamic image sequence is selected for subsequent analysis.
Data Collection and Analysis:
Image analysis software is used for frame-by-frame parsing of dynamic images. Key anatomical structures (pyriform sinus boundaries, anterior edge of the cricoid cartilage lamina, esophageal inlet center) are labeled, and coordinate positioning technology is applied to analyze the following parameters:
Displacement and angle changes of pharyngolaryngeal structures from resting state to peak swallowing phase; Preferred pathway of barium through the oropharynx (unilateral pyriform sinus, bilateral pyriform sinuses, or central region of the cricoid cartilage lamina); Retention time of barium in the pyriform sinus and its passing speed; Expansion amplitude of the pyriform sinus and displacement distance of the cricoid cartilage lamina during swallowing
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient scheduled to take barium meal examination
Key inclusion criteria (7 listed)
- Aged 18-75 years;
- No history of pharyngolaryngeal surgery, trauma, or congenital malformation;
- No swallowing dysfunction, pharyngolaryngeal inflammation, or neurological diseases affecting swallowing;
- No recent use of drugs that affect muscle function (e.g., muscle relaxants, anticholinergics);
- Barium meal examination confirms unobstructed oropharyngeal-esophageal pathway;
Key exclusion criteria (2 listed)
- Presence of diseases that may compress pharyngolaryngeal structures (e.g., goiter, mediastinal mass);
- Allergy to barium sulfate or other components of the barium suspension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Real-time dynamic changes of pharyngolaryngeal structures during swallowing
Time frame: From the initiation of the barium swallow to the complete passage of the bolus through the upper esophageal sphincter, as assessed under videofluoroscopy (an average of 15 minutes per participant).
Measurement of displacement distance of the cricoid cartilage lamina, expansion amplitude of the pyriform sinus, and movement trajectory of the esophageal inlet during swallowing (assessed via dynamic fluoroscopic imaging).
1 secondary outcome
Proportion of participants with consistent instrument insertion pathway and barium's preferred pathway (pyriform sinus)
Time frame: From the initiation of the barium swallow to the complete passage of the bolus through the upper esophageal sphincter, as assessed under videofluoroscopy (an average of 15 minutes per participant).
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 4 Dec 2025.
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.
Pingbo Xu, Ph. D study chair
Zhejiang Cancer Hospital
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 Barium Meal Examination, run by Zhejiang Cancer Hospital 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 7 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. 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?
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 Xiaochun Jin, M.D (+86 571 88122564, ec@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-time dynamic changes of pharyngolaryngeal structures during swallowing (time frame: From the initiation of the barium swallow to the complete passage of the bolus through the upper esophageal sphincter, as assessed under videofluoroscopy (an average of 15 minutes per participant).). 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 4 Dec 2025.