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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024488
Receipt No. R000028164
Scientific Title A study on colonic decompression as bridge to surgery for stageII/III obstructive colon cancer; retrospective multicenter observational study
Date of disclosure of the study information 2016/11/07
Last modified on 2016/10/19

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Basic information
Public title A study on colonic decompression as bridge to surgery for stageII/III obstructive colon cancer; retrospective multicenter observational study
Acronym A study on colonic decompression as bridge to surgery for stageII/III obstructive colon cancer; retrospective multicenter observational study
Scientific Title A study on colonic decompression as bridge to surgery for stageII/III obstructive colon cancer; retrospective multicenter observational study
Scientific Title:Acronym A study on colonic decompression as bridge to surgery for stageII/III obstructive colon cancer; retrospective multicenter observational study
Region
Japan

Condition
Condition Obstructive colon cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical significance of colonic stenting for obstructive left-sided colon cancer retrospectively in stage II and III colon cancer patients for whom colonic depression were requied.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 3-year progression free survival
Key secondary outcomes The frequency of adverse events during colonic depression.
Postoperative complications.
The length of a hospital stay after surgey.
The induction rate of postoperative adjuvant chemotherapy.
Second surgery for synchronous colon cancer.
Pattern of recurrence.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) Patients who underwent curative surgery for obstructive left-sided colon cancer with fstage II and III from January, 2010 to June, 2014.
(2) Patients with histologically confirmed primary colorectal cancer.
(3) Aged 20 to 80 years
(4) Tumor location; Descending colon (D), Sigmoid colon (S), Rectosigmoid colon (RS), and Upper part of rectum (Ra).
(5) ColoRectal Obstruction Scoring System (CROSS) 0 or 1. Patients requiring continuous decompressive procedure or patients with no oral intake.
Key exclusion criteria (1) Patients preoperatively treated with chemotherapy and/or radiotherapy.
(2) ECOG Performance status of 3.
(3) Active multiple malignancy
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shungo Endo
Organization Aizu Medical Center, Fukushima Medical University
Division name Department of Coloproctology
Zip code
Address 21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima, 969-3492, Japan
TEL 0242-75-2100
Email endoswing@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shungo Endo
Organization Aizu Medical Center, Fukushima Medical University
Division name Department of Coloproctology
Zip code
Address 21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima, 969-3492, Japan
TEL 0242-75-2100
Homepage URL
Email endoswing@gmail.com

Sponsor
Institute Japan Colonic Stent Safe Procedure Research Group
Institute
Department

Funding Source
Organization Japan Colonic Stent Safe Procedure Research Group
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 07 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 Preinitiation
Date of protocol fixation
2016 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective study

Management information
Registered date
2016 Year 10 Month 19 Day
Last modified on
2016 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028164

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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