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.
Lugol's iodine chromoendoscopy is the commonly used method for detecting and diagnosing esophageal squamous cell carcinoma. However, iodine can induce mucosal irritation and has been commonly associated with adverse retrosternal symptoms, including retrosternal pain and/or heartburn. The existing research shows that spraying iodine solution neutralizers (Sodium thiosulfate solution, N-acetylcysteine, and vitamin C solution) after esophageal iodine chromoendoscopy can alleviate patient discomfort. However, a recent study has shown that excessive iodine concentration or excessive dosage of iodine can still increase patient discomfort even under spraying an iodine solution neutralizer. It is currently unclear whether the factors affecting patient tolerance are the iodine solution concentration or the total dosage of iodine used. Therefore, the multicenter randomized controlled trial will compare the patient's tolerance for the 1% and 5% iodine solutions under the same iodine dosage conditions. The trial will help determine the specific reasons influencing patient tolerance. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
450
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.
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.
Ankang Central Hospital
Ankang, Shaanxi, China
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China
Air Force 986 Hospital
Xi'an, Shaanxi, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
The First Affiliated Hospital of Shihezi University
Shihezi, Xinjiang, China
Visual analogue scale scores at 30 minutes after chromoendoscopy
According to the visual analogue scale, participants will be asked to score based on pain or discomfort 30 minutes after chromoendoscopy.
Time frame: 30 minute after endoscopy
The color objective evaluation after chromoendoscopy
After spraying Lugol's iodine, the esophageal mucosa displaying a homogeneous dark brown staining was classified as normal, while faded or unstained lesions larger than 0.5 cm were deemed potential high-grade intraepithelial neoplasia or mucosal cancer. The Lugol's unstained lesions were further evaluated for the presence of the pink-color sign and photographed 2-3 minutes after Lugol's iodine staining. The images were also taken at 30 cm distal to the incisors at 2-3 minutes after Lugol's iodine staining if no lesion was found. The images were retrospectively analyzed and scored for an objective evaluation based on the L\* a\* b\* (L\* = light/dark; a\* = red/green; b\* = yellow/blue) color values in the CIELAB color space system.
Time frame: 2-3 minutes after spraying Lugol's iodine.
The color subjective evaluation after chromoendoscopy
The endoscopist will be asked to complete a questionnaire survey immediately after chromoendoscopy. The questionnaire asked the endoscopist to rate the staining effect as good (The color concentration is sufficient and the color retention time is adequate) or poor (The color concentration is insufficient and/or the color retention time is inadequate).
Time frame: During endoscopy.
Heart rate variability
The percentage of heart rate change 5 min (only for unanesthetized participants) or 30 min compared to that before endoscopy.
Time frame: 5 minute or 30 minute after endoscopy
The incidence rate of the need for additional iodine solution spraying
When the endoscopist believes that insufficient esophageal iodine staining affects the detection or diagnosis of lesions, they can spray additional iodine solution. The incidence rate of the need for additional iodine solution spraying of the two groups will be compared.
Time frame: During endoscopy.
The dosage of additional iodine spraying
When the endoscopist believes that insufficient esophageal iodine staining affects the detection or diagnosis of lesions, they can spray additional iodine solution. The dosage of additional iodine spraying of the two groups will be compared.
Time frame: During endoscopy
Visual analogue scale scores at 5 minutes after chromoendoscopy
According to the visual analogue scale, participants without sedation or general anesthesia will be asked to score based on pain or discomfort 5 minutes after chromoendoscopy.
Time frame: 5 minute after endoscopy
The incidence rate of esophageal spasms
The incidence rate of esophageal spasms of the two groups will be compared.
Time frame: During endoscopy
The incidence rate of adverse incidents
The incidence rate of adverse incidents of the two groups will be compared.
Time frame: Up to 48 hours after the endoscopy
The incidence rate of upper abdominal discomfort or pain.
Participants will be asked to describe retrosternal discomfort symptoms and corresponding location at 5 minutes (only for unanesthetized participants)) and 30 minutes after chromoendoscopy. The incidence rate of upper abdominal discomfort or pain will be compared between the two groups.
Time frame: 5 minute or 30 minute after endoscopy
Associated factors for visual analogue scale scores
Visual analogue scale scores may be influenced by other factors. Univariable analysis will first be used to identify potential factors that influenced visual analogue scale scores. All possible factors will then be included in multivariable analysis.
Time frame: Up to 48 hours after the endoscopy
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