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

NCT ID: NCT06063941

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2024-04-30

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

1% iodine solution arm

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

Group Type: ACTIVE_COMPARATOR

1% Lugol's iodine solution

Intervention Type: 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% iodine solution arm

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

Group Type: EXPERIMENTAL

5% Lugol's iodine solution

Intervention Type: 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.

Interventions

1% Lugol's iodine solution

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.

Intervention Type: DRUG

5% Lugol's iodine solution

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankang Central Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of ShiheziI University

UNKNOWN

Sponsor Role: collaborator

Xi'an International Medical Center Hospital

OTHER

Sponsor Role: collaborator

Air Force 986 Hospital

UNKNOWN

Sponsor Role: collaborator

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Zhiguo Liu

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhiguo Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital of Digestive DIsease

Locations

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

Xi'an, Shaanxi, China

The First Affiliated Hospital of Shihezi University

Shihezi, Xinjiang, China

Countries

China

References

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Reference Type: BACKGROUND

PMID: 34371004 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31783028 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11174292 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32950597 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17190773 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20396664 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15173818 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31669091 (View on PubMed)

Other Identifiers

KY20232274-F-1

Identifier Type: -

Identifier Source: org_study_id