Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Whether it is More Appropriate to Spray Lugol's Solution From Cervical Esophagus to Esophagogastric Junction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04224363
• Other study ID #: 2020SDU-QILU-G001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: February 2020

Study information

• Verified date: January 2020
• Source: Shandong University
• Contact: Xiuli Zuo, MD,PhD
• Phone: 15588818685
• Email: zuoxiuli[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.

Description:

Chromoendoscopy using Lugol's solution is effective for the detection of early esophageal squamous neoplasia. However, there is no study to investigate the sequence of Lugol's staining during endoscopic procedure.

The aim of this study is to compare the effectiveness and safety of spraying Lugol's solution from cervical esophagus to esophagogastric junction (downward) and from esophagogastric junction to cervical esophagus （upward）during chromoendoscopy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• High risk patients of early esophageal squamous neoplasias.

Exclusion Criteria:

• After esophageal surgery or endoscopic treatment ;

• Known esophageal radiotherapy or chemotherapy ;

• Esophageal stenosis;

• Acute bleeding;

• A known allergy to iodine;

• Coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 seconds);

• Having food retention;

• Severe hepatic ,renal, cardiovascular or metabolic dysfunction ;

• Being pregnant or lactating.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Procedure:
• staining from cervical esophagus to esophagogastric junction
This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction (downward)during chromemdoscopy.
• staining from esophagogastric junction to cervical esophagus
This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus(upward)during chromemdoscopy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image Quality	Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality.	intraoperative
Secondary	Adverse events	Adverse events of the two groups.	24 hours
Secondary	Dose	Usage of Lugol's solution in each group.	intraoperative
Secondary	Effectiveness	Detection rate of esophageal squamous cell carcinoma of the two groups.	1 month
Secondary	Tolerance	The 4-point scale was used to assess the tolerance of endoscopist to the esophageal spasm caused by Lugol's solution which prevent endoscopy from passing. 1-4 means the resistance as intolerable, tolerable, mild, or non-existing.	intraoperative