UMIN-CTR Clinical Trial

Public title

Evaluation of the intestinal blood flow near the rectosigmoid junction using the ICG fluorescence method in a colorectal cancer surgery

Acronym

Evaluation of the intestinal blood flow near the rectosigmoid junction using the ICG fluorescence method

Scientific Title

Evaluation of the intestinal blood flow near the rectosigmoid junction using the ICG fluorescence method in a colorectal cancer surgery

Scientific Title:Acronym

Evaluation of the intestinal blood flow near the rectosigmoid junction using the ICG fluorescence method

Region

Japan

Condition

colorectal cancer

Classification by specialty

Gastroenterology	Surgery in general	Gastrointestinal surgery
Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluation of the intestinal blood flow near the rectosigmoid junction using the ICG fluorescence method in a colorectal cancer surgery

Basic objectives2

Others

Basic objectives -Others

clinical anatomy

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

The incidence of the absence of the anastomosis between the suprarectal artery and the last sigmoidal brabch

Key secondary outcomes

1. evaluation of blood flow of the anastomotic site
2. incidence rate of anastomotic leakage
3. distance from boederline of blood flow between the suprarectal artery and the last sigmoidal brabch to peritoneal reflection

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Indocyanine green injection at the colorectal surgery

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1 Colorectal cancer surgery patient
2 Performance status 0 - 2
3 Written informed consent

Key exclusion criteria

1 Allergic hypersensitivity of the indocyanine green
2 Allergic hypersensitivity of the iodine

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Jun Watanabe

Organization

Yokosuka Kyosai Hospital

Division name

Department of Surgery

Zip code

Address

1-16 Yonegahama street, Yokosuka, Kanagawa

TEL

046-822-2710

Email

Name of contact person

1st name
Middle name
Last name	Jun Watanabe

Organization

Yokosuka Kyosai Hospital

Division name

Department of Surgery

Zip code

Address

TEL

046-822-2710(ext7704)

Homepage URL

Email

nabe-jun@comet.ocn.ne.jp

Institute

Yokosuka Kyosai Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

横須賀共済病院（神奈川県）

Date of disclosure of the study information

2013

Year

07

Month

13

Day

URL releasing protocol

http://rd.springer.com/journal/384/30/3/page/1

Publication of results

Published

URL related to results and publications

http://rd.springer.com/journal/384/30/3/page/1

Number of participants that the trial has enrolled

Results

International Journal of Colorectal Disease March 2015 Volume 30 Issue 3 p 329-335

Purpose

It has been reported that some patients do not have an anastomosis of a marginal artery near the rectosigmoid junction, but the frequency of this condition and its clinical significance so far remain unclear. The aim of this study was to evaluate the blood flow at the marginal artery near the rectosigmoid junction.

Methods

We enrolled consecutive patients with a preoperative diagnosis of left-sided colon cancer or rectal cancer who underwent surgery with lymph node dissection. During the operation, the blood flow through the point of origin of the last sigmoid arterial branch, originating from the inferior mesenteric artery, was interrupted, and the rectosigmoid junction was supplied by only the marginal artery. We injected indocyanine green intravenously and observed the blood flow using a near-infrared camera system.

Results

A total of 119 consecutive patients were enrolled in this study. Sixty-eight patients (57.1 %) had a good anastomosis of the marginal artery near the rectosigmoid junction (type A). In 27 patients (22.7 %), a fluorescence border was recognized, but the fluorescence border diminished within 60 s (Type B). In 18 patients (15.1 %), delayed fluorescence was recognized over 60 s (type C), and 6 patients (5.0 %) had no fluorescence at all (type D). A mean length of 14.8 cm was found from the peritoneal reflection to fluorescence border of blood flow.

Conclusions

This study proves that cases without the anastomosis of the marginal artery of the rectosigmoid junction truly exist, using studies in living humans (UMIN000011186).

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

Recruitment status

Completed

Date of protocol fixation

2012

Year

11

Month

15

Day

Date of IRB

Anticipated trial start date

2013

Year

07

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

07

Month

13

Day

Last modified on

2015

Year

02

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013105