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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02005809

Acronym

SLEGD

Enrollment

268

Registered

2013-12-09

Start date

2013-03-31

Completion date

2015-03-31

Last updated

2013-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Neoplasms

Keywords

Endoscopic submucosal dissection, gastric neoplasm, second look endoscopy

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.

Interventions

PROCEDUREsecond look endoscopy

Second look endoscopy includes observation or prophylactic bleeding control of ESD site.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Post-ESD bleeding rate according to second look endoscopy	Up to 60days

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactMoo In Park, MD

myjuyoung@hanmail.net82519905061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026