Novel Endoscopic Resection of Upper Gastrointestinal Subepithelial Tumors Originating From the Muscularis Propria
1 other identifier
interventional
11
1 country
1
Brief Summary
Endoscopic submucosal tumor resection using biopsy forceps was performed for 11 consecutive patients who had clinical indications for lesion removal. Following the injection around a submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled away to form a "tent". The tissue was dissected using an electrocoagulating current. In brief, the tumor was dissected from the muscularis propria layer and then carefully removed using forceps. Demographic data, indication for intervention, safety of the procedure and follow-up will be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2016
CompletedFirst Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedJanuary 31, 2017
January 1, 2017
1.9 years
January 25, 2017
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Complete resection rate
Proportion of study patients with a histologically confirmed diagnosis after Forcep Strip Method
1 week
Secondary Outcomes (5)
The mean procedure time
1day
mean tumor size
1day
the mean hospitalization time
1week
Adverse Events
5 days
Tumor status after endoscopic resection
10 months
Study Arms (1)
Forcep Strip Method Treatment
EXPERIMENTALpatients who have Gastrointestinal Subepithelial Tumors Originating from the Muscularis Propria are enrolled
Interventions
Following the injection around a submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled away to form a "tent". The tissue was dissected using an electrocoagulating current.
Eligibility Criteria
You may qualify if:
- the tumor size had increased on the follow up gastroscopy,
- the EUS showed a well demarcated GI SET, or
- they requested an endoscopic excision because the tumor was causing them anxiety.
You may not qualify if:
- they had predominantly extraluminal growth,
- they were ill demarcated, or
- the EUS showed adjacent lymph nodes with a malignant appearance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Anam Hospital
Seoul, Anamdong , Seongbuk-gu, 136-705, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hoon Jai Chun
Korea University Anam Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
January 25, 2017
First Posted
January 31, 2017
Study Start
January 1, 2015
Primary Completion
November 30, 2016
Study Completion
November 30, 2016
Last Updated
January 31, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share