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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033931
Receipt No. 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

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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
Email 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
Email gonchan5@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and infectious diseases center Komagome Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038697

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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