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

Phase 3

• Conditions: Gastric Neoplasms
• Interventions: Procedure: second look endoscopy

• Registration Number: NCT02005809
• Lead Sponsor: Kosin University Gospel Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-11-26
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-04
• Last Update Submitted: 2013-12-04
• Study First Posted: 2013-12-09
• Last Update Posted: 2013-12-09
• Primary Completion: 2015-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 268

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Second look endoscopy	second look endoscopy	This group is performed second look endoscopy about 24 hours later from endoscopic submucosal dissection.

Primary Outcome Measures

Name	Time	Method
Post-ESD bleeding rate according to second look endoscopy	Up to 60days

Secondary Outcome Measures

Name	Time	Method
bleeding complication rate according to location of lesion in stomach.	Up to 60days	Fundus, cardia, upper body, mid body, lower body, antrum anterior wall, posterior wall, great curvature, lesser curvature
Bleeding rate according to size of resected specimen	Up to 60days	longest diameter of specimen: millimeter
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	Up to 60days	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

Trial Locations

Locations (1)

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of