Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma

Xijing Hospital of Digestive Diseases

Status

Completed

Conditions

Esophageal Superficial Mucosal Lesion

Treatments

Procedure: ESD

Procedure: ESTD

Study type

Interventional

Funder types

Other

Identifiers

NCT03404921

KY20172066-1

Details and patient eligibility

About

To evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma.

Full description

This multicenter, prospective, randomized, controlled study aims to evaluate the efficacy and safety of the tunnel technique in ESD of superficial esophageal squamous cell carcinoma (ESCC). Specifically the tunnel technique would be compared to conventional method on the procedure time and the muscular layer injury rate in patients scheduled for ESD with indication of ESCC.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥18 years;
Biopsy confirmed early esophageal cancer and high-grade intraepithelial neoplasia (HGIN)which were eligible for conventional ESD indications;
Suspected localized mucosal lesions detected by endoscopy.

Exclusion criteria

Malignancy or other advanced disease with a life expectancy of < 6 months as judged by the investigator.
The ASA classification of physical status ≥ 4 as judged by the investigator.
Severe hepatic disease or renal disease
Ability to understand and the willingness to sign a written informed consent document.
Major cardiovascular event at enrollment or within 3 months prior to enrollment such as stroke, myocardial infarction, or hospitalization for treatment of unstable angina pectoris as judged by the investigator.
Haemorrhagic disorder.
Patients who had a history of esophagectomy or a recurrent lesion.
Planned treatment with: warfarin (including other vitamin K antagonists), cisapride,phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus,theophylline, lidocaine, nifedipine.
Pregnancy, planned pregnancy or lactation. Women of childbearing potential must use reliable and medically accepted methods of birth control, as judged by the investigator.
Known or suspected alcohol, drug or medication abuse.
Any condition associated with poor compliance as judged by the investigator.
Participation in any study involving administration of an investigational product or device within the preceding 14 days prior to enrollment.
Involvement in the planning and conduct of the study. Previous enrollment in the present study