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

Kosin University Gospel Hospital

Status and phase: Unknown; Phase 3

Conditions: Gastric Neoplasms

Treatments: Procedure: second look endoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02005809

2nd look EGD

Details and patient eligibility

About

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.

Enrollment: 268 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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268 participants in 2 patient groups

Second look endoscopy

Active Comparator group

Description:

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

Treatment:

Procedure: second look endoscopy

without second look endoscopy

No Intervention group

Description:

This group is not performed second look endoscopy after ESD