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

Shandong University

Status: Unknown

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Procedure: staining from cervical esophagus to esophagogastric junction; Procedure: staining from esophagogastric junction to cervical esophagus

Study type: Interventional

Funder types: Other

Identifiers

NCT04224363

2020SDU-QILU-G001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Downward Staining

Experimental group

Description:

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

Treatment:

Procedure: staining from cervical esophagus to esophagogastric junction

Upward Staining

Experimental group

Description:

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

Treatment:

Procedure: staining from esophagogastric junction to cervical esophagus