Prospective Randomized Trial Comparing Endoscopic Submucosal Dissection Against Laparoscopic Assisted Gastrectomy for Treatment of Early Gastric Cancer
NCT ID: NCT03136354
Last Updated: 2019-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2009-05-31
2019-07-31
Brief Summary
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This study will be the unique first study in the literature to show that intramucosal early gastric cancer can be adequately treated by endoscopic submucosal dissection with better perioperative, functional and quality of life outcomes when compared to laparoscopic assisted gastrectomy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ESD Group
Endoscopic Submucosal Dissection
Endoscopic Submucosal Dissection
LAG Group
Laparoscopic Assisted Gastrectomy
Laparoscopic assisted Gastrectomy
Interventions
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Endoscopic Submucosal Dissection
Laparoscopic assisted Gastrectomy
Eligibility Criteria
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Inclusion Criteria
2. Preoperative investigation with magnifying endoscopy and / or EUS predicted to be mucosal lesion
3. Any tumor size if the early gastric cancer has no ulceration
4. Tumor size ≤ 3cm if the early gastric cancer has ulceration
Exclusion Criteria
2. Poorly differentiated or signet ring cell adenocarcinoma
3. Age \> 80 or \< 16
4. Pregnancy
5. ASA \> IV
16 Years
80 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Philip Wai Yan Chiu
Professor
Principal Investigators
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Philip W Chiu, MD, FRCSEd
Role: PRINCIPAL_INVESTIGATOR
Dept of Surgery, The Chinese University of Hong Kong
Locations
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Combined Endoscopy Center, Prince of Wales Hospital
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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CRE-2009.165T
Identifier Type: -
Identifier Source: org_study_id
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