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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Kosin University Gospel Hospital
Sponsor:
Collaborator:
Inje University
Information provided by (Responsible Party):
Park Moo In, Kosin University Gospel Hospital
ClinicalTrials.gov Identifier:
NCT02005809
First received: November 26, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Gastric Neoplasms
Procedure: second look endoscopy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Impact of Second-look Endoscopy After Endoscopic Submucosal Dissection of Gastric Neoplasm

Resource links provided by NLM:


Further study details as provided by Kosin University Gospel Hospital:

Primary Outcome Measures:
  • Post-ESD bleeding rate according to second look endoscopy [ Time Frame: Up to 60days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • bleeding complication rate according to location of lesion in stomach. [ Time Frame: Up to 60days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 60days ] [ Designated as safety issue: No ]
    longest diameter of specimen: millimeter

  • Post ESD bleeding rate according to total procedure time of endoscopic submucosal dissection [ Time Frame: Up to 60days ] [ Designated as safety issue: No ]
  • Post ESD bleeding rate according to bleeding degree during endoscopic submucosal dissection [ Time Frame: Up to 60days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 268
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005809

Contacts
Contact: Moo In Park, MD 82519905061 myjuyoung@hanmail.net

Locations
Korea, Republic of
Kosin University Gospel Hospital Recruiting
Busan, Korea, Republic of, 602-702
Contact: KiHwan Ku, MD    82519905209    lci7ku@naver.com   
Sponsors and Collaborators
Kosin University Gospel Hospital
Inje University
  More Information

Publications:

Responsible Party: Park Moo In, Department of internal medicine, Kosin University Gospel Hospital, Kosin University Gospel Hospital
ClinicalTrials.gov Identifier: NCT02005809     History of Changes
Other Study ID Numbers: 2nd look EGD
Study First Received: November 26, 2013
Last Updated: December 4, 2013
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Kosin University Gospel Hospital:
Endoscopic submucosal dissection
gastric neoplasm
second look endoscopy

Additional relevant MeSH terms:
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on October 16, 2014