UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011690 |
|---|---|
| Receipt number | R000013668 |
| Scientific Title | Efficacy of endoscopic submucosal dissection for gastrointestinal subepithelial tumors within the submucosa: multicenter study |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2020/03/16 17:26:43 |
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Basic information
Public title
Efficacy of endoscopic submucosal dissection for gastrointestinal subepithelial tumors within the submucosa: multicenter study
Acronym
Endoscopic submucosal dissection for gastrointestinal subepithelial tumor within the submucosa
Scientific Title
Efficacy of endoscopic submucosal dissection for gastrointestinal subepithelial tumors within the submucosa: multicenter study
Scientific Title:Acronym
Endoscopic submucosal dissection for gastrointestinal subepithelial tumor within the submucosa
Region
| Japan |
Condition
Condition
gastrointestinal subepithelial tumors within submucosa
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We invetigate the efficacy, safety, and long term result of endoscopic submucosal dissection for gastrointestinal subepithelial tumors within submucosa
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
en bloc rection rate
Key secondary outcomes
complications, procedure time, emergency,emergency surgery migration rate, additional surgery rate, recurrence rate, survival observation period
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 submucosal dissection:ESD
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.lesion contained within the SM layer
2.all patients whom informed consents were obtained
3. symptomatic SET strongly suspected to be a benign tumor on conventional endoscopic imaging, EUS and computed tomography
4.Tumor with the increasing tendency of tumor size greater than 1.5 times the rate before
5. confirmed histological diagnosis of carcinoid tumor; carcinoid tumor 10 mm; no lymph node or distant metastasis found
6. Granular cell tumor confirmed by preoperative tissue diagnosis
7. Indefinite SMT which is suspected malignancy in the image preoperatively
Key exclusion criteria
1.We exclude cysts, lipoma and vascular lesions with typical features in the image and asymptomatic symptoms
2.Lesions postoperative stenosis is expected, beyond the half cercumferential lumen
3.Lesions that can not check the remaining submucosa of the third layer by EUS
4.patients who do not meeting the following conditions: physical status I
to II and normal complete blood cell counts and prothrombin times are excluded
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Kobara |
Organization
Faculty of Medicine, Kagawa University
Division name
Gastroenterology and Neurology
Zip code
761-0793
Address
Kagawa University, 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
087-891-2156
kobara@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kobara |
Organization
Kagawa University Hospital
Division name
Gastroenterology and Neurology
Zip code
761-0793
Address
Kagawa University, 1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
087-898-5111
Homepage URL
kobara@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagawa University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ehime University Hospital, Kagawa Saiseikai hospital, Kochi Medical Center, Kochi Red Cross Hospital, Shimane Prefectural Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Kagawa University
Address
1750-1 Ikenobe, Miki, Kita
Tel
0878985111
chosa@med.kagawa-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
Possible
Number of participants that the trial has enrolled
57
Results
The rates of en bloc resection, curative resection, complications were 98.2%, 66.7%, 7.7% for overall (n=57), 100%, 61.9%, 2.4% for NET (n=42), and 93.3%, 80%, 20% for indeterminate SELs (n=15), respectively. The rates of curative resection were poor with 20% in stomach (n=5), 33% in duodenum (n=3), compared with 71% in rectum (n=24). Including conservative approach for 11 of 16 NETs who resulted in non-curative resection, no tumor recurrences occurred in all cases during follow-up period.
Results date posted
| 2019 | Year | 09 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
57 consecutive patients (35 males, 22 females, median age: 63 years, range: 32-86 years) with GI SELs were analyzed, and were divided into definite NET (n=42) and indeterminate SELs (n=15) including one symptomatic SEL.
Participant flow
All patients were evaluated by routine endosonography (EUS: high-frequency miniprobe, 20 MHz, UM-3R; Olympus, Tokyo, Japan) and enhanced CT. All data were extracted and compiled into a central database at Kagawa University.
Adverse events
Complications included the incidence of any bleeding requiring an endoscopic hemostatic procedure. Perforation was defined as GI wall penetration observed during or after the procedure. Severe complication was defined as the requirement of immediate surgery repair.
Outcome measures
The overall rates of en bloc resection, curative resection, complications, and procedure time of all 57 cases were evaluated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 09 | Day |
Last modified on
| 2020 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013668
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