Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm

Study Overview
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Brief Summary
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Gastroenterologists often follow up second look endoscopy after endoscopic submucosal dissection(ESD) of gastric neoplasms because they want to prevent bleeding of procedure sites. But Goto suggested in his retrospective analysis that a second-look endoscopy after endoscopic submucosal dissection for gastric epithelial neoplasm may be unnecessary. So, the investigators try to identify the hypothesis prospectively in this study.

Official Title
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Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm

Conditions
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Gastric Neoplasms

Intervention / Treatment
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* Procedure: second look endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histological confirmed patients(gastric adenoma or adenocarcinoma) performed gastric ESD patients about 24 hours before Exclusion Criteria: perforation after ESD piecemeal resection of ESD specimen hemostatic agent or proton pump inhibitor users before ESD heparin or antiplatelet agent users Serious concurrent infection or nonmalignant illness that is uncontrolled Psychiatric disorder that would preclude compliance Allergy history to proton pump inhibitor

Ages Eligible for Study
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Minimum Age: 20 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Second look endoscopy<br>This group is performed second look endoscopy about 24 hours later from endoscopic submucosal dissection. | Procedure: second look endoscopy<br>* Second look endoscopy includes observation or prophylactic bleeding control of ESD site.<br>|
| No Intervention: without second look endoscopy<br>This group is not performed second look endoscopy after ESD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ESD bleeding rate according to second look endoscopy |  | Up to 60days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding complication rate according to location of lesion in stomach. | Fundus, cardia, upper body, mid body, lower body, antrum anterior wall, posterior wall, great curvature, lesser curvature | Up to 60days | 
| Bleeding rate according to size of resected specimen | longest diameter of specimen: millimeter | Up to 60days | 
| Post ESD bleeding rate according to total procedure time of endoscopic submucosal dissection |  | Up to 60days | 
| Post ESD bleeding rate according to bleeding degree during endoscopic submucosal dissection | Mild: bleeding control time: <1/3 of total ESD procedure time. Moderate: bleeding control time: 1/3 1/2 of total ESD procedure time Severe: bleeding control time: >1/2 of total ESD procedure time | Up to 60days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic submucosal dissection, gastric neoplasm, second look endoscopy