Esophageal Squamous Cell CarcinomaNCT04224363
Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction
A study testing staining from cervical esophagus to esophagogastric junction and staining from esophagogastric junction to cervical esophagus in people with Esophageal Squamous Cell Carcinoma, run by Shandong University.
Trial summary
The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- staining from cervical esophagus to esophagogastric junction and staining from esophagogastric junction to cervical esophagus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Feb 2020
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High risk patients of early esophageal squamous neoplasias.
Who cannot join
- After esophageal surgery or endoscopic treatment ;
- Known esophageal radiotherapy or chemotherapy ;
- Esophageal stenosis;
- Acute bleeding;
- A known allergy to iodine;
- Coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 seconds);
Show all 9Show fewer
- Having food retention;
- Severe hepatic ,renal, cardiovascular or metabolic dysfunction ;
- Being pregnant or lactating.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.
Read the detailed description
Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, there is no study to investigate the sequence of Lugol's staining during endoscopic procedure.
The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- staining from cervical esophagus to esophagogastric junction, staining from esophagogastric junction to cervical esophagus
- Keywords
- Lugol's solution, staining sequence, Esophageal Squamous Cell Carcinoma, Effectiveness, Safety
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
staining from cervical esophagus to esophagogastric junctionProcedure or surgery
This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.
staining from esophagogastric junction to cervical esophagusProcedure or surgery
This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Downward Staining | Experimental | This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy. Receives: Procedure: staining from cervical esophagus to esophagogastric junction |
| Upward Staining | Experimental | This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy. Receives: Procedure: staining from esophagogastric junction to cervical esophagus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality
Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality.
Measured: intraoperative
Secondary outcomes (4)
Adverse events
Adverse events of the two groups.
Measured: 24 hours
Dose
Usage of Lugol's solution in each group.
Measured: intraoperative
Effectiveness
Detection rate of esophageal squamous cell carcinoma of the two groups.
Measured: 1 month
Tolerance
The 4-point scale was used to assess the tolerance of endoscopist to the esophageal spasm caused by Lugol's solution which prevent endoscopy from passing. 1-4 means the resistance as intolerable, tolerable, mild, or non-existing.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, MD,PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224363
- Sponsor's protocol ID
- 2020SDU-QILU-G001
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 13 Jan 2020
- 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction
- ClinicalTrials.gov ID
- NCT04224363
- Acronym / sponsor ID
- 2020SDU-QILU-G001
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Lugol's solution, staining sequence, Esophageal Squamous Cell Carcinoma, Effectiveness, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 13 Jan 2020 (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 aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.
Detailed description
Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, there is no study to investigate the sequence of Lugol's staining during endoscopic procedure.
The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Downward Staining | Experimental | Procedure: staining from cervical esophagus to esophagogastric junctionThis group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy. |
| Upward Staining | Experimental | Procedure: staining from esophagogastric junction to cervical esophagusThis group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- High risk patients of early esophageal squamous neoplasias.
Key exclusion criteria (9 listed)
- After esophageal surgery or endoscopic treatment ;
- Known esophageal radiotherapy or chemotherapy ;
- Esophageal stenosis;
- Acute bleeding;
- A known allergy to iodine;
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 |
|---|---|---|
| staining from cervical esophagus to esophagogastric junctionThis group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy. | Procedure or surgery | Downward Staining |
| staining from esophagogastric junction to cervical esophagusThis group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy. | Procedure or surgery | Upward Staining |
Primary outcome
Image Quality
Time frame: intraoperative
Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality.
4 secondary outcomes
Adverse events
Time frame: 24 hours
Dose
Time frame: intraoperative
Effectiveness
Time frame: 1 month
Tolerance
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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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.
Xiuli Zuo, MD,PhD principal investigator
Qilu Hospital of Shandong University
Questions about this trial
What is this clinical trial studying?
A study testing staining from cervical esophagus to esophagogastric junction and staining from esophagogastric junction to cervical esophagus in people with Esophageal Squamous Cell Carcinoma, run by Shandong University.
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 9 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 13 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Zuo, MD,PhD (15588818685, zuoxiuli@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Quality (time frame: intraoperative). 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 13 Jan 2020; AzTrials last refreshed its copy on 3 Nov 2026.