UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034048 |
|---|---|
| Receipt number | R000038811 |
| Scientific Title | Evaluation of usefulness of GIF-2TQ260M in endoscopic submucosal dissection for gastric cancer. |
| Date of disclosure of the study information | 2018/09/05 |
| Last modified on | 2021/09/07 13:05:27 |
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Basic information
Public title
Evaluation of usefulness of GIF-2TQ260M in endoscopic submucosal dissection for gastric cancer.
Acronym
Evaluation of GIF-2TQ260M in ESD for gastric cancer.
Scientific Title
Evaluation of usefulness of GIF-2TQ260M in endoscopic submucosal dissection for gastric cancer.
Scientific Title:Acronym
Evaluation of GIF-2TQ260M in ESD for gastric cancer.
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of endoscopic submucosal dissection using the GIF-2TQ260M for gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
procedure time
Key secondary outcomes
accident occurrence rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
GIF-2TQ260M
Interventions/Control_2
other scopes
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed with gastric cancer.
2. The absolute indication and expanded indications in the Gastric Cancer Treatment Guidelines.
3. one leision
4. Tumor location upper or middle
5. PS 0 or 1 or2
Key exclusion criteria
a pregnant woman
residual stomach cancer
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Hamada |
Organization
Southern Tohoku general hospital
Division name
Gastroenterology
Zip code
963-8563
Address
7-115, Yatsuyamada, Koriyama-shi
TEL
0249345322
koichi.hamada@mt.strins.or.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Hamada |
Organization
Southern Tohoku general hospital
Division name
Gastroenterology
Zip code
963-8563
Address
7-115, Yatsuyamada, Koriyama-shi
TEL
0249345322
Homepage URL
koichi.hamada@mt.strins.or.jp
Sponsor or person
Institute
Southern Tohoku general hospital
Institute
Department
Personal name
Funding Source
Organization
non
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
Southern Tohoku General Hospital
Address
7-115, Yatsuyamada, Koriyama-shi, Fukushima 963-8563, Japan
Tel
0249345322
koichi.hamada@mt.strins.or.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
| 2018 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.thieme-connect.com/products/ejournals/abstract/10.1055/a-1288-0570
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/products/ejournals/abstract/10.1055/a-1288-0570
Number of participants that the trial has enrolled
60
Results
Sixty patients were analyzed; 30 who underwent C-ESD and 30 who underwent M-ESD. The mean ESD procedure times for the M-ESD and C-ESD groups were 34.6+-17.2 and 47.2+-26.7 minutes, respectively (p=0.034). Muscle layer damage occurred significantly less frequently in the M-ESD group (0.2+-0.7 vs 0.7+-1.0; p=0.036).
Results date posted
| 2021 | Year | 09 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants who were scheduled to receive gastric ESD were enrolled in this study. The inclusion criteria were as follows: participants >= 20 years of age; participants with histologically proven gastric adenocarcinoma; and participants who met the absolute or expanded indication for ESD according to the Japanese gastric cancer treatment guidelines 2014 (ver. 4);
Participant flow
A total of 60 patients were enrolled and analyzed. Thirty patients were assigned to the C-ESD and M-ESD groups, respectively.
Adverse events
No significant differences were noted in the incidence of delayed bleeding, intraoperative perforation, and delayed perforation between the C-ESD and the M-ESD groups. Damage to the muscle layers occurred significantly less frequently in the M-ESD group
Outcome measures
The primary outcome was the ESD procedure time. The secondary outcomes were the dissection speed and operative complications; intraoperative perforation, delayed bleeding, delayed perforation, and damage to the muscle layers during ESD.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 05 | Day |
Last modified on
| 2021 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038811
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/09/07 | umin upload.xlsx |
