UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024488 |
|---|---|
| Receipt number | 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 | 2021/04/23 12:25:27 |
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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 | Shungo |
| Middle name | |
| Last name | Endo |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Coloproctology
Zip code
969-3492
Address
21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima, 969-3492, Japan
TEL
0242-75-2100
endoswing@gmail.com
Public contact
Name of contact person
| 1st name | Shungo |
| Middle name | |
| Last name | Endo |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Department of Coloproctology
Zip code
969-3492
Address
21-2, Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu, Fukushima, 969-3492, Japan
TEL
0242-75-2100
Homepage URL
endoswing@gmail.com
Sponsor or person
Institute
Japan Colonic Stent Safe Procedure Research Group
Institute
Department
Personal name
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
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima-shi, Fukushima
Tel
024-547-1825
rs@fmu.ac.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
| 2016 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/33247313/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33247313/
Number of participants that the trial has enrolled
301
Results
The 3-year relapse-free survival rate in patients in the Surgery group was 74.8%, while that in patients in the SEMS group and TADT group were 69.0% (p？=？0.39) and 55.3% (p？=？0.006), respectively. The technical success rate was not statistically different, but the clinical success rate was significantly higher in the SEMS group than in the TADT group (p？=？0.0040).
Results date posted
| 2021 | Year | 04 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The subjects were patients with histologically proven stage II/III left-sided colon or upper rectal cancer with obstruction, who underwent subsequent surgery with curative resection between January 2010 and December 2014.
Participant flow
NA
Adverse events
NA
Outcome measures
The 3-year RFS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
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
| 2021 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028164
