High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy
NCT06063941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450
Last updated 2024-08-27
Summary
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.
Conditions
Interventions
- DRUG
-
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.
- DRUG
-
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.
Sponsors & Collaborators
-
Ankang Central Hospital
collaborator OTHER -
The First Affiliated Hospital of ShiheziI University
collaborator UNKNOWN -
Xi'an International Medical Center Hospital
collaborator OTHER -
Air Force 986 Hospital
collaborator UNKNOWN -
Xijing Hospital of Digestive Diseases
lead OTHER
Principal Investigators
-
Zhiguo Liu, M.D. · Xijing Hospital of Digestive DIsease
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-10-10
- Primary Completion
- 2024-04-30
- Completion
- 2024-04-30
Countries
- China
Study Locations
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