UMIN-CTR Clinical Trial

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

Obstructive colon cancer

Classification by specialty

Gastroenterology

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

endoswing@gmail.com

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

Email

endoswing@gmail.com

Institute

Japan Colonic Stent Safe Procedure Research Group

Institute

Department

Personal name

Organization

Japan Colonic Stent Safe Procedure Research Group

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fukushima Medical University

Address

1 Hikarigaoka, Fukushima-shi, Fukushima

Tel

024-547-1825

Email

rs@fmu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

07

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/33247313/

Publication of results

Published

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

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 related information

retrospective study

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