Status:
COMPLETED
Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Xijing Hospital of Digestive Diseases
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Tongji Hospital
Conditions:
Esophageal Superficial Mucosal Lesion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the efficacy and safety profile of endoscopic submucosal tunnel dissection for superficial esophageal squamous cell carcinoma.
Detailed 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). Specifical...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03404921
Start Date
January 1 2018
End Date
July 31 2018
Last Update
July 17 2019
Active Locations (1)
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1
Xijing Hospital of Digestive Diseases
Xi'an, Shaanxi, China, 710032