UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042682 |
|---|---|
| Receipt number | R000048688 |
| Scientific Title | Prospective study to develop optimal range of lymph node dissection for duodenal tumor |
| Date of disclosure of the study information | 2020/12/21 |
| Last modified on | 2021/12/20 12:52:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective study to develop optimal range of lymph node dissection for duodenal tumor
Acronym
Prospective study to develop optimal range of lymph node dissection for duodenal tumor
Scientific Title
Prospective study to develop optimal range of lymph node dissection for duodenal tumor
Scientific Title:Acronym
Prospective study to develop optimal range of lymph node dissection for duodenal tumor
Region
| Japan |
Condition
Condition
duodenal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop optimal range of lymph node dissection for duodenal tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Range of lymphatic flow visualized by ICG during duodenectomy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Local injection of ICG to duodenal submucosa
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. Diagnosed with deep submucosa primary non-ampullary duodenal tumor in preoperative radiography
2. Tumor limited to duodenum, no transmission to other organs
3. No specific limitations in terms of sample cells in biopsy
4. Implementation of surgery for duodenal tumor
5. 20 years old or older
6. Written informed consent to this study
Key exclusion criteria
1. Pregnant with drug allergy history to (iodine, ICG) or asthma history
2. Tumor is at duodenal papilla
3. Indications for endoscopic treatment where the tumor is found remaining in the mucosa by preoperative radiography
4. Evaluated not to be appropriate for inclusion by attending physician
5. When the subject refuses to participate in this study after enrolling
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Kawakubo |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
1608582
Address
35 Shinanomachi, Shunjuku-ku, Tokyo
TEL
0333531211
hkawakubo@keio.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Matsuda |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
1608582
Address
35 Shinanomachi, Shunjuku-ku, Tokyo
TEL
0333531211
Homepage URL
s.matsuda.a8@keio.jp
Sponsor or person
Institute
Department of Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shunjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.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
| 2020 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | 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 | 12 | Month | 07 | Day |
Last modified on
| 2021 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048688
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
