NCT06063941Completed
High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy
High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy: a Multicenter, Randomized Equivalence Trial
Source: ClinicalTrials.gov · Last updated 27 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 450 (actual)
- First submitted
- 25 Sept 2023
- Start date
- 10 Oct 2023
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06063941
What you commit to
- Study type: Interventional
- Participants enrolled: 450
- From 10 Oct 2023 to the primary completion date, 30 Apr 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients after upper gastrointestinal surgery;
Other illness
- 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 who could not cooperate with the observation and data collection including patients with mental disorders, severe neurosis, dysgnosia or communication disorder;
Other
- Patients with postoperative esophageal stenosis affecting endoscopic observation;
- Patients with advanced-stage tumors;
- Patients who do not agree to sign informed consent forms or follow the trial requirement.
Who the study is looking for
- Patients undergoing esophageal Lugol's iodine chromoendoscopy.
- Age ≥ 18
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ankang Central Hospital Coordinator of this site? Confirm its status | Ankang | China | Unknown status |
| The First Affiliated Hospital of Shihezi University Coordinator of this site? Confirm its status | Shihezi | China | Unknown status |
| Xijing Hospital of Digestive Diseases Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Xi'an International Medical Center Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Air Force 986 Hospital Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.