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

Not Applicable

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Procedure: staining from esophagogastric junction to cervical esophagus; Procedure: staining from cervical esophagus to esophagogastric junction

• Registration Number: NCT04224363
• Lead Sponsor: Shandong University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2020-01
• Study Start: 2020-01
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Last Update Submitted: 2020-01-08
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upward Staining	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.
Downward Staining	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.

Primary Outcome Measures

Name	Time	Method
Image Quality	intraoperative	Image quality is blindly quantified by a 4-point scale from the endoscopists. A higher score representing higher image quality.

Secondary Outcome Measures

Name	Time	Method
Tolerance	intraoperative	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.
Effectiveness	1 month	Detection rate of esophageal squamous cell carcinoma of the two groups.
Dose	intraoperative	Usage of Lugol's solution in each group.
Adverse events	24 hours	Adverse events of the two groups.