UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041795 |
|---|---|
| Receipt number | R000047703 |
| Scientific Title | Endoscopic resection for gastric submucosal tumor |
| Date of disclosure of the study information | 2020/09/15 |
| Last modified on | 2024/03/19 09:30:31 |
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Basic information
Public title
Endoscopic resection for gastric submucosal tumor
Acronym
ER for gastric SMT
Scientific Title
Endoscopic resection for gastric submucosal tumor
Scientific Title:Acronym
ER for gastric SMT
Region
| Japan |
Condition
Condition
gastric submucosal tumor
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of endoscopic resection for gastric submucosal tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
En block resection rate by endoscopy
Key secondary outcomes
Pathological complete resection rate, endoscopic procedure complete resection rate, adverse event, procedure time, comparison of preoperative diagnosis and pathological diagnosis, overall survival at five years, and disease specific survival at five years
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic resection
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 11-30mm by EUS and CT
2) intraluminal type
Key exclusion criteria
1) epithelial tumor
2) ulcerative finding by endoscopy
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Noriya |
| Middle name | |
| Last name | Uedo |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL
0669451181
noriya.uedo@oici.jp
Public contact
Name of contact person
| 1st name | Satoki |
| Middle name | |
| Last name | Shichijo |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
TEL
0669451181
Homepage URL
7satoki@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka, Japan
Tel
0669451181
rinri01@opho.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
杏林大学医学部、静岡がんセンター、神戸大学医学部附属病院 国際がん医療・研究センター、横浜市立大学附属市民総合医療センター、大阪国際がんセンター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/den.14717
Number of participants that the trial has enrolled
46
Results
he mean (range) endoscopic tumor size was 18.8 (11-28) mm. The tumor resection and defect closure times were 54 (22-125) min and 33 (12-186) min, respectively. A 100% ER0 was achieved in all 46 patients. The EFTR procedure was accomplished in all patients without surgical intervention. One patient had delayed perforation and was managed endoscopically. GIST accounted for 76% (n = 35) of the cases. R0, R1, and RX rates were 33 (77%), 3 (6.5%), and 7 (15%), respectively.
Results date posted
| 2024 | Year | 03 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
The endoscopic lesion size was 18.8 (11-28) mm. Most lesions (63%) were in the upper third of the stomach. All tumors were of intraluminal growth type. The indications for resection were histologically proven GIST in 27 (59%) patients, increasing size in 12 (26%), and a equal to or larger than 2 cm size in 7 (15%).
Participant flow
From October 2020 to May 2023, 56 consecutive patients were assessed for eligibility at seven facilities (Figure 1). Nine patients refused to participate in this study for following reasons: investigational nature of the treatment (n=6), non-covered by national insurance (n=2), and unwillingness to receive treatment (n=1). One patient was excluded because she received systemic steroid therapy (n=1). Consequently, a total of 46 patients with 46 gastric SMTs were enrolled.
Adverse events
One delayed perforation developed on POD1 and was swiftly managed with endoscopic intervention (Clavien-Dindo Grade IIIa). Intraprocedural hemorrhage was managed via endoscopic forceps coagulation; no case required blood transfusion.
Outcome measures
ER0 status was achieved in all 46 patients (100 % )
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047703
