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

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

Detailed Description
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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.

Official Title
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Efficacy and Safety of Endoscopic Submucosal Tunnel Dissection for Superficial Esophageal Squamous Cell Carcinoma: a Prospective Multicenter Study

Conditions
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Esophageal Superficial Mucosal Lesion

Intervention / Treatment
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* Procedure: ESTD
* Procedure: ESD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESTD group<br>Use tunnelling method during ESD operation | Procedure: ESTD<br>* During the ESTD procedure,after marking and submucosal injection, incisions were made at both the anal and oral sides of the lesion, and the submucosa under the lesion was then dissected to create a tunnel between the distal and proximal incisions. When the endscope reached the lower incision, the distal end of the esophageal lumen could be visualized , then two lateral mucosal incisions were made, thus completing the ESD procedure.<br>|
| Other: ESD group<br>Use traditional method during ESD operation | Procedure: ESD<br>* The ESD procedure involved marking,injection,circumferential cutting, submucosal dissection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The procedure time | Procedure time was defined as the time from marking of the lesion until complete removal of the specimen,including hemostasis. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of bleeding during operation | The hemorrhage observed during the operation | day 1 | 
| The rate of injury to the muscular layer | The injury to the muscular layer observed during the operation | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic submucosal dissection, Endoscopic submucosal tunnelling dissection, procedure time