Clinical trial
High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy: a Multicenter, Randomized Equivalence Trial
Name
KY20232274-F-1
Description
This clinical trial aims to test the participants' tolerance for different concentration iodine solutions during esophageal chromoendoscopy. The main question it aims to answer is:
Under the same iodine dosage, do the participants have the same tolerance for 1% and 5% iodine solutions? Participants will be asked to score based on pain and discomfort and describe symptoms and corresponding location at 5 minutes (only for unanesthetized participants) and 30 minutes after chromoendoscopy.
Trial arms
Trial start
2023-10-10
Estimated PCD
2024-04-30
Trial end
2024-04-30
Status
Recruiting
Treatment
1% Lugol's iodine solution
1% Lugol iodine solution was sprayed from the esophagogastric junction towards a location approximately 20 cm away from the upper incisors in the cervical esophagus.
Arms:
1% iodine solution arm
5% Lugol's iodine solution
Before chromoendoscopy, a 20 ml syringe was employed to draw 3 ml of 5% iodine stock solution and 17 ml air. When staining, the iodine was quickly expelled through the endoscope's working channel at 20 cm of the esophagus from the incisor. An iodine mist was created because of the rapid spurt of the iodine solution and air, which prompts even distribution of the iodine solution on the esophageal wall. The lower segments of the esophageal wall were stained with the remaining iodine solution in the working channel by repeatedly spraying the air/iodine mixture using the syringe, resulting in consistent and uniform staining for the whole esophagus.
Arms:
5% iodine solution arm
Size
450
Primary endpoint
Visual analogue scale scores at 30 minutes after chromoendoscopy
30 minute after endoscopy
Eligibility criteria
Inclusion Criteria:
* Patients undergoing esophageal Lugol's iodine chromoendoscopy.
* Age ≥ 18
Exclusion Criteria:
* Patients allergic to iodine or with hyperthyroidism;
* Patients with esophageal varices, esophageal ulcer or other conditions inadvisable for Lugol chromoendoscopy;
* Patients with severe gastroesophageal reflux disease or reflux symptoms which may interfered with the outcome measures of current study;
* Patients with postoperative esophageal stenosis affecting endoscopic observation;
* Patients who could not cooperate with the observation and data collection including patients with mental disorders, severe neurosis, dysgnosia or communication disorder;
* Patients with advanced-stage tumors;
* Patients after upper gastrointestinal surgery;
* Patients who do not agree to sign informed consent forms or follow the trial requirement.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 450, 'type': 'ESTIMATED'}}
Updated at
2023-10-13
1 organization
Organization
Xijing Hospital of Digestive Diseases