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NCT Number: NCT06063941

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

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.

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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankang Central Hospital, Ankang, Shaanxi, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1% Lugol's iodine solution

Drug

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.

5% Lugol's iodine solution

Drug

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.

Primary outcomes

  1. Visual analogue scale scores at 30 minutes after chromoendoscopy

    Time frame: 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 outcomes

  1. The color objective evaluation after chromoendoscopy

    Time frame: 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.

  2. The color subjective evaluation after chromoendoscopy

    Time frame: 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).

  3. Heart rate variability

    Time frame: 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.

  4. The incidence rate of the need for additional iodine solution spraying

    Time frame: 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.

  5. The dosage of additional iodine spraying

    Time frame: 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.

  6. Visual analogue scale scores at 5 minutes after chromoendoscopy

    Time frame: 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.

  7. The incidence rate of esophageal spasms

    Time frame: During endoscopy

    The incidence rate of esophageal spasms of the two groups will be compared.

  8. The incidence rate of adverse incidents

    Time frame: Up to 48 hours after the endoscopy

    The incidence rate of adverse incidents of the two groups will be compared.

  9. The incidence rate of upper abdominal discomfort or pain.

    Time frame: 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.

  10. Associated factors for visual analogue scale scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Collaborators

  • Air Force 986 Hospital
  • Ankang Central Hospital
  • The First Affilated Hospital of the Medical College, Shihezi University
  • Xi'an International Medical Center Hospital

Registry information

Official study title

High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy: a Multicenter, Randomized Equivalence Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2023
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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