Study Stopped
The investigators decided to terminate the study early because there were no patient candidates available for registration in the center.
A Study on Precutting Methods of Endoscopic Submucosal Dissection for Gastric Neoplasms Located at Lesser Curvature Side of Antrum
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum of lesser curvature side is difficult. Because the antrum of lesser curvature side is dependent position, irrigated water and blood may prevent visual field of ESD. Generally, whole precutting around the lesion during the ESD is performed prior to dissection. However, it is expected that partial precutting method for the lesion located in the antrum of the lesser curvature may improve the visibility of ESD because it can help us the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time of ESD for the lesion located in the antrum of the lesser curvature according to the precutting methods (whole precutting vs. partial precutting).
Trial Health
Trial Health Score
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Started Jul 2013
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2014
CompletedFirst Submitted
Initial submission to the registry
September 15, 2014
CompletedFirst Posted
Study publicly available on registry
September 22, 2014
CompletedJanuary 16, 2019
January 1, 2019
1 year
September 15, 2014
January 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Procedure time
Procedure time for the lesion located in the antrum of lesser curvature according to the precutting methods.
Within 5 mins after the procedure
Secondary Outcomes (1)
En bloc resection rate
Within 7 days after the procedure
Other Outcomes (1)
complete resection rate
Within 7 days after the procedure
Study Arms (2)
Whole precutting group
ACTIVE COMPARATORPartial precutting group
ACTIVE COMPARATORInterventions
Partial precutting will be performed prior to dissection during the ESD.
Whole precutting will be performed prior to dissection during the ESD.
Eligibility Criteria
You may qualify if:
- Over 19 years old
- Patients with gastric adenoma or early gastric cancer
You may not qualify if:
- Patients who has undergone subtotal gastrectomy
- Patients who has undergone gastrostomy
- Patients with local recurred gastric adenoma or early gastric cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sevrance hospital
Seoul, 120-752, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2014
First Posted
September 22, 2014
Study Start
July 26, 2013
Primary Completion
August 12, 2014
Study Completion
August 12, 2014
Last Updated
January 16, 2019
Record last verified: 2019-01