High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy

Not Applicable

Completed

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Drug: 1% Lugol's iodine solution; Drug: 5% Lugol's iodine solution

• Registration Number: NCT06063941
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-10-03
• Study Start: 2023-10-10
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-24
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% iodine solution arm	1% Lugol's iodine solution	Esophageal chromoendoscopy will be performed with a 15 ml volume of 1% Lugol iodine solution.
5% iodine solution arm	5% Lugol's iodine solution	Esophageal chromoendoscopy will be performed with a 3 ml volume of 5% iodine stock solution.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale scores at 30 minutes after chromoendoscopy	30 minute after endoscopy	According to the visual analogue scale, participants will be asked to score based on pain or discomfort 30 minutes after chromoendoscopy.

Secondary Outcome Measures

Name	Time	Method
The color objective evaluation after chromoendoscopy	2-3 minutes after spraying Lugol's iodine.	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.
The color subjective evaluation after chromoendoscopy	During endoscopy.	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).
The dosage of additional iodine spraying	During endoscopy	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.
The incidence rate of esophageal spasms	During endoscopy	The incidence rate of esophageal spasms of the two groups will be compared.
The incidence rate of adverse incidents	Up to 48 hours after the endoscopy	The incidence rate of adverse incidents of the two groups will be compared.
Associated factors for visual analogue scale scores	Up to 48 hours after the endoscopy	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.
The incidence rate of the need for additional iodine solution spraying	During endoscopy.	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.
Heart rate variability	5 minute or 30 minute after endoscopy	The percentage of heart rate change 5 min (only for unanesthetized participants) or 30 min compared to that before endoscopy.
Visual analogue scale scores at 5 minutes after chromoendoscopy	5 minute after endoscopy	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.
The incidence rate of upper abdominal discomfort or pain.	5 minute or 30 minute after endoscopy	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.

Trial Locations

Locations (5)

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; 🇨🇳 Xian, Shaanxi, China

The First Affiliated Hospital of Shihezi University; 🇨🇳 Shihezi, Xinjiang, China