UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039061 |
|---|---|
| Receipt number | R000044419 |
| Scientific Title | Technical feasibility and safety of Underwater endoscopic mucosal resection versus Cold snare polypectomy for superficial non-ampullary Duodenal epithelial tumor; A randomized control trials. |
| Date of disclosure of the study information | 2020/01/06 |
| Last modified on | 2020/07/09 11:12:59 |
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Basic information
Public title
Technical feasibility and safety of Underwater endoscopic mucosal resection versus Cold snare polypectomy for superficial non-ampullary Duodenal epithelial tumor; A randomized control trials.
Acronym
DUC study
Scientific Title
Technical feasibility and safety of Underwater endoscopic mucosal resection versus Cold snare polypectomy for superficial non-ampullary Duodenal epithelial tumor; A randomized control trials.
Scientific Title:Acronym
DUC study
Region
| Japan |
Condition
Condition
Superficial non-ampullary duodenal epithelial tumor
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a comparative study on the efficacy and safety of underwater endoscopic mucosal resection (UEMR) and cold snare polypectomy (CSP) for duodenal non-papillary epithelial tumors of 12 mm or less.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint is the percentage of complete pathological resection (negative horizontal and vertical resection margins and proportion of resected specimens with submucosa).
Key secondary outcomes
Secondary endpoints include en bloc resection rate, R0 resection rate, resected lesion diameter, treatment time, pathological evaluation of resected lesions (resection thickness, resection distance, presence or absence of mucosal muscle plate, presence or absence of submucosal layer), accidental occurrence (bleeding, perforation, etc.) And the rate of remnants and recurrences after 6 months.
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
| Maneuver |
Interventions/Control_1
Regarding UEMR, the lumen is first evacuated and then saline is injected. Thereafter, the snare is placed on the lesion and strangled. After confirming that there is no tumor left on the margin, the lesion is resected. After resection, confirm that there are no complications such as bleeding or perforation and no residual lesions. Finally, clipping is performed on the resected part.
Interventions/Control_2
As for CSP, when the lumen is filled with air (carbon dioxide) and the lesion is visually recognized, a snare is placed on the lesion and strangulation is performed. After confirming that there is no tumor left on the margin, resection is performed using a snare wire for CSP without applying power. In principle, clipping after resection is not performed, and if spurting bleeding is recognized, hemostatic closure is performed at the discretion of the attending physician.
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
Patients aged 20 years or older who are scheduled to undergo endoscopic treatment for lesions diagnosed as low-grade duodenal tumors of 12 mm or less in our department. If there are multiple lesions, only the largest lesion, which is 12 mm or less, shall be regarded as accurate and assigned. Regarding postoperative complications, if only the same lesion is involved and bleeding or perforation occurs in other lesions of multiple lesions, it is regarded as different.
Key exclusion criteria
1) Patients with multiple duodenal tumors associated with Familiar adenomatous polyposis and hereditary non-polyposis colorectal cancer
2) Patients who strongly suspect cancer / high grade adenoma in preoperative examination and biopsy
3) Patients who have undergone surgery for the upper gastrointestinal tract
4) Patients with blood coagulation dysfunction, patients who cannot manage anticoagulant / antiplatelet agents according to the guidelines for medical treatment of gastrointestinal endoscopy
5) Severe organ failure case
6) Cases determined by the attending physician to be inappropriate for registration
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio University, school of medicine
Division name
Gastroenterology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
motohikokato@keio.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Kiguchi |
Organization
Keio University, school of medicine
Division name
Cancer center, division of research and development for minimal invasive treatment
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
kiguchiyoshiyuki@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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, Shinjyuku-ku, Tokyo, Japan
Tel
0333531211
kiguchiyoshiyuki@keio.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 | 01 | Month | 06 | 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 | 01 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2022 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044419
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