UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027455 |
|---|---|
| Receipt number | R000031452 |
| Scientific Title | Phase 2 study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery. |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2019/05/31 11:12:20 |
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Basic information
Public title
Phase 2 study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery.
Acronym
WING DRAIN Study
Scientific Title
Phase 2 study of safety and efficacy of a transanal tube (WING DRAIN) for the prevention of anastomotic leakage after rectal cancer surgery.
Scientific Title:Acronym
WING DRAIN Study
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
WING DRAIN Study is a phase 2 trial to evaluate the safety and efficacy of a novel transanal tube:WING DRAIN for the prevention of anastomotic leakage after low anterior resection surgery for rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Symptomatic leakage rate
Key secondary outcomes
Symptomatic leakage rate and Radiological leakage rate
Complication rate connected with WING DRAIN
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
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We placed transanal tube:WING DRAIN at low anterior resection surgery, and removed it at 4 or 5 postoperative days.
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. Rectal cancer is located at within 10cm above the anal verge
2. Histologically proven rectal adenocarcinoma on biopsy
3. Initial operation for rectal cancer excluding local excision
4. The patients undergoing low anterior resection with mechanical anastomosis
5. The patients have no ileus preoperatively.
6. Organ function is preserved
7. Patient with ECOG performance status of 0, 1, or 2
8. Written informed consent to participation in this trial
Key exclusion criteria
1. Emergency operation
2. Other conditions judged ineligible by physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Ito |
Organization
National Cancer Center Hospital East
Division name
Colorectal Surgery
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
TEL
+81-4-7133-1111
maito@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Nishizawa |
Organization
National Cancer Center Hospital East
Division name
Colorectal Surgery
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
TEL
+81-4-7133-1111
Homepage URL
yunishiz@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Muranaka Medical Instruments.CO. LTD.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center Hospital
Tokyo Metropolitan Cnncer and Infectious Diseases Center Komagome Hospital
Iwate Medical University School of Medicine
Kitasato University School of Medicine
Shizuoka Cancer Center
Name of secondary funder(s)
Muranaka Medical Instruments.CO. LTD.
IRB Contact (For public release)
Organization
National Cancer Center Hospital East
Address
6-5-1, Kashiwanoha, Kashiwa , Chiba , Japan 277-8577
Tel
04-7133-1111
yunishiz@east.ncc.go.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
| 2017 | Year | 07 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 23 | Day |
Last modified on
| 2019 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031452
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