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

Not Applicable

Completed

• Conditions: Esophageal Superficial Mucosal Lesion
• Interventions: Procedure: ESTD; Procedure: ESD

• Registration Number: NCT03404921
• Lead Sponsor: Xijing Hospital of Digestive Diseases

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). 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-13
• Study First Submitted QC: 2018-01-13
• Study First Posted: 2018-01-19
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-31
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESTD group	ESTD	Use tunnelling method during ESD operation
ESD group	ESD	Use traditional method during ESD operation

Primary Outcome Measures

Name	Time	Method
The procedure time	day 1	Procedure time was defined as the time from marking of the lesion until complete removal of the specimen,including hemostasis.

Secondary Outcome Measures

Name	Time	Method
The rate of bleeding during operation	day 1	The hemorrhage observed during the operation
The rate of injury to the muscular layer	day 1	The injury to the muscular layer observed during the operation

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China