UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033931 |
|---|---|
| Receipt number | R000038697 |
| Scientific Title | A study on colonic decompression as bridge to surgery for obstructive colon cancer. |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2018/08/28 23:22:01 |
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Basic information
Public title
A study on colonic decompression as bridge to surgery for obstructive colon cancer.
Acronym
A study on colonic decompression as bridge to surgery for obstructive colon cancer.
Scientific Title
A study on colonic decompression as bridge to surgery for obstructive colon cancer.
Scientific Title:Acronym
A study on colonic decompression as bridge to surgery for obstructive colon cancer.
Region
| Japan |
Condition
Condition
obstructive colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety and long-term results of surgery (BTS: Bridge to Surgery) after decompression with colon stent for obstructive colon cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Complication rate during decompression and perioperative period.
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Primary tumor resection within 3-30 days after stent(Nite-S colonic stent) placement.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Colonic stricture presumed secondary to a carcinoma by preoperative imaging modalities such as abdominal and pelvic CT or colonoscope.
2)Patient with at least one of the following obstructive findings;
1. Intolerable for oral intake or necessary for fasting at the judgement of the attending physician
2. No fart
3. Bloating or abdominal pain
4. Abnormality of defecation such as constipation or frequent diarrhea
5. Nausea or vomiting
3)Written informed consent to participation in this trial
Key exclusion criteria
1)chemotherapy or radiotherapy before primary resection was performed
2)active overlapping cancer affecting the prognostic evaluation
3)Any other cases who are regarded as inadequate for study enrollment by investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | daisuke nakano |
Organization
Tokyo Metropolitan Cancer and infectious diseases center Komagome Hospital
Division name
Surgery
Zip code
Address
504, 6-12-14, komagome, toshima-ku, Tokyo.
TEL
09034294524
gonchan5@cick.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | daisuke nakano |
Organization
Tokyo Metropolitan Cancer and infectious diseases center Komagome Hospital
Division name
Surgery
Zip code
Address
504, 6-12-14, komagome, toshima-ku, Tokyo.
TEL
09034294524
Homepage URL
gonchan5@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and infectious diseases center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
tokyo metropolitan government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
がん・感染症センター都立駒込病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 28 | Day |
Last modified on
| 2018 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038697
