Clinical trial · Interventional
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
NCT06063941CI-TRIAL-00080237completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1% Lugol's iodine solution | Drug | — | UNRESOLVED |
| 5% Lugol's iodine solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1% iodine solution arm
- description
- Esophageal chromoendoscopy will be performed with a 15 ml volume of 1% Lugol iodine solution.
- interventionNames
- Drug: 1% Lugol's iodine solution
- type
- EXPERIMENTAL
- label
- 5% iodine solution arm
- description
- Esophageal chromoendoscopy will be performed with a 3 ml volume of 5% iodine stock solution.
- interventionNames
- Drug: 5% Lugol's iodine solution
Primary outcomes (1)
- measure
- Visual analogue scale scores at 30 minutes after chromoendoscopy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (8)
- BACKGROUNDGuo Q, Fan X, Zhu S, Zhao X, Fang N, Guo M, Liu Z, Han Y. Comparing N-acetylcysteine with sodium thiosulfate for relieving symptoms caused by Lugol's iodine chromoendoscopy: a randomized, double-blind trial. Gastrointest Endosc. 2022 Feb;95(2):249-257. doi: 10.1016/j.gie.2021.07.025. Epub 2021 Aug 8. PMID 34371004
- BACKGROUNDJin D, Wang J, Zhan Q, Huang K, Wang H, Zhang G, Xu Y, Yao J, Sun R, Huang Q, Ye F, Zhang G. The safety and efficacy of 2% vitamin C solution spray for relief of mucosal irritation caused by Lugol chromoendoscopy: a multicenter, randomized, double-blind, parallel trial. Gastrointest Endosc. 2020 Sep;92(3):554-564. doi: 10.1016/j.gie.2019.11.028. Epub 2019 Nov 26. PMID 31783028
- BACKGROUNDKondo H, Fukuda H, Ono H, Gotoda T, Saito D, Takahiro K, Shirao K, Yamaguchi H, Yoshida S. Sodium thiosulfate solution spray for relief of irritation caused by Lugol's stain in chromoendoscopy. Gastrointest Endosc. 2001 Feb;53(2):199-202. doi: 10.1067/mge.2001.110730. PMID 11174292
- BACKGROUNDLiu M, Zhou R, Guo C, Xu R, Liu A, Yang H, Li F, Duan L, Shen L, Wu Q, Liu Z, Liu F, Liu Y, Pan Y, Cai H, Weiss NS, He Z, Ke Y. Size of Lugol-unstained lesions as a predictor for risk of progression in premalignant lesions of the esophagus. Gastrointest Endosc. 2021 May;93(5):1065-1073.e3. doi: 10.1016/j.gie.2020.09.020. Epub 2020 Sep 18. PMID 32950597
- BACKGROUNDPark JM, Seok Lee I, Young Kang J, Nyol Paik C, Kyung Cho Y, Woo Kim S, Choi MG, Chung IS. Acute esophageal and gastric injury: complication of Lugol's solution. Scand J Gastroenterol. 2007 Jan;42(1):135-7. doi: 10.1080/00365520600825141. PMID 17190773
- BACKGROUNDTsurumaru D, Utsunomiya T, Matsuura S, Komori M, Kawanami S, Ishibashi T, Honda H. Gastric mucosal changes caused by Lugol's iodine solution spray: endoscopic features of 64 cases on screening esophagogastroduodenoscopy. Gastroenterol Res Pract. 2010;2010:494195. doi: 10.1155/2010/494195. Epub 2010 Apr 12.