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

NCT06063941 | Completed DMC

• 1 other identifier: KY20232274-F-1
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 5

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Lugol chromoendoscopy; Adverse event

Outcome Measures

Primary Outcomes (1)

• 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.

  30 minute after endoscopy

Secondary Outcomes (10)

• The color objective evaluation after chromoendoscopy

  2-3 minutes after spraying Lugol's iodine.

• The color subjective evaluation after chromoendoscopy

  During endoscopy.

• Heart rate variability

  5 minute or 30 minute after endoscopy

• The incidence rate of the need for additional iodine solution spraying

  During endoscopy.

• The dosage of additional iodine spraying

  During endoscopy

Study Arms (2)

1% iodine solution arm

ACTIVE COMPARATOR

Esophageal chromoendoscopy will be performed with a 15 ml volume of 1% Lugol iodine solution.

Drug: 1% Lugol's iodine solution

5% iodine solution arm

EXPERIMENTAL

Esophageal chromoendoscopy will be performed with a 3 ml volume of 5% iodine stock solution.

Drug: 5% Lugol's iodine solution

Interventions

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.

1% iodine solution arm

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.

5% iodine solution arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing esophageal Lugol's iodine chromoendoscopy.
• Age ≥ 18

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead
• Ankang Central Hospital: collaborator
• The First Affiliated Hospital of ShiheziI University: collaborator
• Xi'an International Medical Center Hospital: collaborator
• Air Force 986 Hospital: collaborator

Study Sites (5)

Ankang Central Hospital

Ankang, Shaanxi, China

Location

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710036, China

Location

Air Force 986 Hospital

Xi'an, Shaanxi, 710054, China

Location

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, 710100, China

Location

The First Affiliated Hospital of Shihezi University

Shihezi, Xinjiang, 832000, China

Location

Related Publications (8)

• Guo 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 BACKGROUND

• Jin 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 BACKGROUND

• Kondo 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 BACKGROUND

• Liu 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 BACKGROUND

• Park 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 BACKGROUND

• Tsurumaru 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.

  PMID: 20396664 BACKGROUND

• Thuler FP, de Paulo GA, Ferrari AP. Chemical esophagitis after chromoendoscopy with Lugol's solution for esophageal cancer: case report. Gastrointest Endosc. 2004 Jun;59(7):925-6. doi: 10.1016/s0016-5107(04)00173-7. No abstract available.

  PMID: 15173818 BACKGROUND

• Gotoda T, Kanzaki H, Okamoto Y, Obayashi Y, Baba Y, Hamada K, Sakae H, Abe M, Iwamuro M, Kawano S, Kawahara Y, Okada H. Tolerability and efficacy of the concentration of iodine solution during esophageal chromoendoscopy: a double-blind randomized controlled trial. Gastrointest Endosc. 2020 Apr;91(4):763-770. doi: 10.1016/j.gie.2019.10.022. Epub 2019 Oct 25.

  PMID: 31669091 BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhiguo Liu, M.D.

  Xijing Hospital of Digestive DIsease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 3, 2023
• Study Start: October 10, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)