Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Study Overview
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Brief Summary
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Endoscopic submucosal dissection (ESD) is a newly developed technique in the field of endoscopic treatment for GI neoplasms, because of its high rate of en bloc resection. The purpose of this study is to evaluate the efficacy and safety of ESD for GI neoplasms.

Detailed Description
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Endoscopic mucosal resection (EMR) is widely accepted as a minimally invasive treatment for GI neoplasms.However, one disadvantage of EMR is that lesions larger than 2 cm in diameter must be removed in pieces, which may result in a high recurrence rate of residual tumor tissue. In addition, in most patients, pathological assessment cannot be conducted after the procedure. ESD can overcome the disadvantages of EMR. However, it is difficult to perform ESD for GI neoplasms because of the high rate of complications.

Official Title
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Endoscopic Submucosal Dissection for Gastrointestinal Neoplasms

Conditions
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Digestive System Diseases

Intervention / Treatment
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* Behavioral: endoscopic submucosal dissection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Submucosal tumor Mucosal tumor (T1) in patients unsuitable for surgery Exclusion Criteria: Endoscopic ultrasound (EUS) or CT signs of metastasis Insufficient access to tumor

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Submucosal Dissection<br>Single-arm for ESD procedure and retrospective surgical procedure(Laparoscopy, Open surgery)data collection | Behavioral: endoscopic submucosal dissection<br>* ESD was carried out by using a single-channel upper gastrointestinal endoscope with a water-jet system (Q260J; Olympus Optical Co, Tokyo, Japan) and a high-frequency generator with an automatically controlled system (ENDOCUT mode) (Erbotom ICC 200; ERBE Elektromedizin GmbH, Tübingen, Germany). The transparent attachment was fitted on the tip of the endoscope mainly to obtain a constant endoscopic view and to create tension on the connective tissue for the submucosal dissection.<br>* Other names: Endoscopic Submucosal Dissection(ESD);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The lesion result before ESD | Including the location, morphology and size under endoscopy and narrow banding image of lesion. | within 7 days before ESD | 
| Short-term result after ESD | Including en bloc and curative resection rate, the specimen size, complications, lateral and vertical margin exposure of tumor, and lymphatic or vascular invasion. | whithin 7 days after ESD | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of ESD procedure | including the endoscopic examination at 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD | 3months, 6months, 1year, 2years, 3years, 4years and 5years after ESD | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic submucosal dissection, gastrointestinal neoplasm