Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction
1 other identifier
interventional
80
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 8, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedJanuary 13, 2020
January 1, 2020
1 month
January 8, 2020
January 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Image Quality
Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality.
intraoperative
Secondary Outcomes (4)
Adverse events
24 hours
Dose
intraoperative
Effectiveness
1 month
Tolerance
intraoperative
Study Arms (2)
Downward Staining
EXPERIMENTALThis group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.
Upward Staining
EXPERIMENTALThis group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.
Interventions
This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.
This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.
Eligibility Criteria
You may qualify if:
- High risk patients of early esophageal squamous neoplasias.
You may not qualify if:
- 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);
- Having food retention;
- Severe hepatic ,renal, cardiovascular or metabolic dysfunction ;
- Being pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiuli Zuo, MD,PhD
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of Qilu Hospital gastroenterology department
Study Record Dates
First Submitted
January 8, 2020
First Posted
January 13, 2020
Study Start
January 1, 2020
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
January 13, 2020
Record last verified: 2020-01