UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046922 |
|---|---|
| Receipt number | R000052935 |
| Scientific Title | A comparative study of the treatment outcome of transanal decompression tube and colorectal stent for stage II/III obstructive colorectal cancer; retrospective multicenter observational study |
| Date of disclosure of the study information | 2022/02/15 |
| Last modified on | 2026/08/24 15:14:56 |
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Basic information
Public title
A comparative study of the treatment outcome of transanal decompression tube and colorectal stent for stage II/III obstructive colorectal cancer; retrospective multicenter observational study
Acronym
A comparative study of the treatment outcome of transanal decompression tube and colorectal stent for stage II/III obstructive colorectal cancer; retrospective multicenter observational study
Scientific Title
A comparative study of the treatment outcome of transanal decompression tube and colorectal stent for stage II/III obstructive colorectal cancer; retrospective multicenter observational study
Scientific Title:Acronym
Outcome of transanal decompression tube and colorectal stent for obstructive colorectal cancer
Region
| Japan |
Condition
Condition
Obstructive Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery | Operative medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the treatment results of transanal ileus tube and colorectal stent placement for obstructive colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relapse Free Survival
Key secondary outcomes
Overall Survival, Postoperative Complication
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) 20 to 80 years old
2) Performance status 0-2
3) Histopathologically diagnosed as advanced stage II or III (UICC TNM classification 8th edition)
4) No preoperative chemotherapy or preoperative radiation therapy
5) A transanal decompression tube or colorectal stent was placed before surgery.
6) Radical resection was performed from January 2008 to December 2019.
Key exclusion criteria
1) multiple cancers
2) a history of other cancers within 5 years before surgery
(However, carcinoma in situ or intramucosal cancer, which are considered to be cured by local treatment, do not include)
3) Those with lesions in the lower rectum (Rb)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Numata |
Organization
Kanagawa Cancer Center
Division name
Gastrointestinal Surgery
Zip code
2418515
Address
2-3-2 Nakao, Asahiku, Yokohama, Kanagawa, Japan
TEL
0455202222
koji-numata@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Numata |
Organization
Kanagawa Cancer Center
Division name
Gastrointestinal Surgery
Zip code
2418515
Address
2-3-2 Nakao, Asahiku, Yokohama, Kanagawa, Japan
TEL
0455202222
Homepage URL
koji-numata@hotmail.co.jp
Sponsor or person
Institute
Kanagawa Cancer Center
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
Kanagawa Cancer Center
Address
2-3-2 Nakao, Asahiku, Yokohama, Kanagawa, Japan
Tel
0455202222
koji-numata@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
| 2022 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/epdf/10.1002/jso.27454?msockid=11c8c83873796a363068db6272056b27
Number of participants that the trial has enrolled
225
Results
Among 225 patients with obstructive colorectal cancer, outcomes were compared between TDT and SEMS. After propensity score matching, 57 TDT and 114 SEMS patients were analyzed. Three-year RFS (66.7% vs 69.9%) and OS (90.5% vs 87.1%) did not differ significantly. SEMS was associated with fewer stomas, shorter postoperative hospital stays, and fewer grade >=2 complications, without compromising long-term outcomes.
Results date posted
| 2026 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 225 patients with obstructive colorectal cancer who underwent curative resection after preoperative decompression at 10 participating institutions between January 2008 and December 2020 were included. Before propensity score matching, 77 patients were assigned to the TDT group and 148 to the SEMS group. After 1:2 propensity score matching, 57 patients in the TDT group and 114 in the SEMS group were analyzed. After matching, age, sex, ASA physical status, serum CEA level, tumor location, CROSS score, surgical approach, histological type, pathological T and N categories, pathological stage, and use of adjuvant chemotherapy were generally balanced between the groups. Patients aged >=70 years accounted for 63.2% of the TDT group and 57.0% of the SEMS group, while pathological stage III disease accounted for 49.1% and 50.0%, respectively.
Participant flow
A total of 225 patients with obstructive colorectal cancer who underwent R0 resection after preoperative placement of either a TDT or SEMS were enrolled. Of these, 77 patients were treated with TDT and 148 with SEMS. Propensity scores were estimated using clinically relevant variables including age, sex, ASA physical status, tumor location, surgical approach, pathological T category, and pathological N category. After 1:2 propensity score matching, 57 patients in the TDT group and 114 patients in the SEMS group, for a total of 171 patients, were included in the matched analysis.
Adverse events
Postoperative complications of Clavien-Dindo grade >=2 occurred in 33.3% of patients in the TDT group and 21.1% in the SEMS group and were significantly less frequent in the SEMS group (p=0.04). Anastomotic leakage occurred in 3.5% and 6.1% of patients, respectively (p=0.43), ileus in 8.8% and 9.6% (p=1.00), enteritis in 1.8% and 0% (p=0.34), and surgical site infection in 5.3% and 0% (p=0.04). Because of the retrospective nature of the study, detailed data on complications associated with TDT or SEMS placement and the duration of device placement were not available.
Outcome measures
Relapse free survival (RFS)
RFS was calculated from the date of surgery. After propensity score matching, the 3 year RFS rate was 66.7% in the TDT group and 69.9% in the SEMS group, with no statistically significant difference between the groups (p=0.54). The median follow up period was 40.8 months.
Overall survival (OS) and postoperative complications
OS was calculated from the date of surgery. The 3 year OS rate was 90.5% in the TDT group and 87.1% in the SEMS group, with no significant difference between the groups (p=0.52). Postoperative complications of Clavien-Dindo grade >=2 were significantly less frequent in the SEMS group (p=0.04). The SEMS group also had a significantly lower stoma construction rate (p=0.007) and a significantly shorter postoperative hospital stay (p<0.001). Recurrence occurred in 29.8% of patients in the TDT group and 27.2% in the SEMS group, with no significant differences in recurrence rate or recurrence pattern.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2022 | Year | 02 | Month | 15 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052935
