UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040771 |
|---|---|
| Receipt number | R000046558 |
| Scientific Title | Comparison of the oncological outcomes of stenting as a bridge to surgery and surgery alone in obstructive colorectal cancer; a retrospective study |
| Date of disclosure of the study information | 2020/06/15 |
| Last modified on | 2020/06/15 17:42:45 |
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Basic information
Public title
Study on the effectiveness of stenting for obstructive colorectal cancer at Niigata City Hospital
Acronym
Study of stenting for obstructive colorectal cancer
Scientific Title
Comparison of the oncological outcomes of stenting as a bridge to surgery and surgery alone in obstructive colorectal cancer; a retrospective study
Scientific Title:Acronym
Comparison stenting as a bridge to surgery and surgery alone in obstructive colorectal cancer
Region
| Japan |
Condition
Condition
Obstructive colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the oncological outcomes of bridge to surgery (BTS) using a self-expanded metallic stent (SEMS) compared with surgery alone for obstructive colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative recurrence rate through 8 years after introduction of colorectal stent at Niigata City General Hospital.
Key secondary outcomes
the short-term surgical outcome, survival rate, recurrence sites.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent curative resection for obstructive colorectal cancer at Niigata City General Hospital were divided into the bridge to surgery with stenting group (treated from April 2012, when stenting for malignant bowel obstruction was covered by insurance in Japan, to 2019) and the surgery alone group (treated from 2008 to 2019).
The surgery alone group included patients who did not undergo decompression and patients who underwent non-surgical bowel decompression at the oral side of obstructive colorectal cancer and had a nasal ileus tube or nasogastric tube placed before curative resection.
In this study, obstructive colorectal cancer was diagnosed by computed tomography (CT) and colonoscopy in which urgent decompression was deemed necessary.
Key exclusion criteria
The patients who underwent preoperative bowel decompression procedures by trans-anal tube or stoma creation at the oral side of the cancer were excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Uehara |
Organization
Niigata City General Hospital
Division name
Department of Digestive Surgery
Zip code
950-1197
Address
463-7, Shumoku, Chuo-ku, Niigata City, Niigata, Japan.
TEL
+81-25-281-5151
hiroaki.u@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Uehara |
Organization
Niigata City General Hospital
Division name
Department of Digestive Surgery
Zip code
950-1197
Address
463-7, Shumoku, Chuo-ku, Niigata City, Niigata, Japan.
TEL
+81-25-281-5151
Homepage URL
hiroaki.u@hotmail.co.jp
Sponsor or person
Institute
Niigata City General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Niigata City General Hospital
Address
463-7, Shumoku, Chuo-ku, Niigata City, Niigata, Japan.
Tel
+81-25-281-5151
hiroaki.u@hotmail.co.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
| 2020 | Year | 06 | Month | 15 | 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
85
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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 06 | Month | 15 | Day |
Last modified on
| 2020 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046558
