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

December 4, 2013 updated by: Park Moo In, Kosin University Gospel Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

268

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-702
        • Recruiting
        • Kosin University Gospel Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding complication rate according to location of lesion in stomach.
Time Frame: Up to 60days
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
Time Frame: Up to 60days
longest diameter of specimen: millimeter
Up to 60days
Post ESD bleeding rate according to total procedure time of endoscopic submucosal dissection
Time Frame: Up to 60days
Up to 60days
Post ESD bleeding rate according to bleeding degree during endoscopic submucosal dissection
Time Frame: 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
Up to 60days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kosin University Gospel Hospital

Collaborators

Inje University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

December 4, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

December 9, 2013

Last Update Submitted That Met QC Criteria

December 4, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2nd look EGD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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