UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009731
Receipt number R000011405
Scientific Title Evaluation of clinical efficiency of intraoperative intestinal blood supply measurement using photodynamic eye and ICG
Date of disclosure of the study information 2013/03/01
Last modified on 2023/01/16 21:57:40

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Basic information

Public title

Evaluation of clinical efficiency of intraoperative intestinal blood supply measurement using photodynamic eye and ICG

Acronym

Evaluation of clinical efficiency of intraoperative intestinal blood supply measurement using photodynamic eye and ICG

Scientific Title

Evaluation of clinical efficiency of intraoperative intestinal blood supply measurement using photodynamic eye and ICG

Scientific Title:Acronym

Evaluation of clinical efficiency of intraoperative intestinal blood supply measurement using photodynamic eye and ICG

Region

Japan


Condition

Condition

gastrointestinal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of efficiency of intraoperative intestinal blood flow using photodynamic eye and ICG.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visibility of intestinal blood flow

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Photodynamic eye using ICG

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1 Scheduled for elective surgery for gastrointestinal cancer
2.Age>=20
3. Written informed consent

Key exclusion criteria

none

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yoshiharu
Middle name
Last name Sakai

Organization

Kyoto University Hospital

Division name

Department of Surgery

Zip code

606-8507

Address

Shogoinkawaharacho, Sakyo, Kyoto

TEL

075-366-7595

Email

ysakai@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Kawada

Organization

Kyoto University Hospital

Division name

Dept of Surgery

Zip code

606-8507

Address

Shogoinkawaharacho, Sakyo, Kyoto

TEL

075-366-7595

Homepage URL

http://gisurg.kuhp.kyoto-u.ac.jp/

Email

kkawada@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name

Yoshiharu Sakai


Funding Source

Organization

Kyoto University

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

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-u.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

2013 Year 03 Month 01 Day


Related information

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/28281123/

Publication of results

Partially published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/28281123/

Number of participants that the trial has enrolled

407

Results

The anastomotic leakage (AL) rate was 10.4% (5/48) in patients with ICG angiography, compared with 6.9% (7/101) in cases without ICG angiography (P=0.52). In patients with ICG angiography, poor perfusion of the proximal colon judged by ICG angiography led to additional colon resection in 27.1% (13/48).
Multivariate analysis indicated only lateral lymph node dissection remained significantly associated with AL.

Results date posted

2023 Year 01 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Consecutive 155 rectal cancer patients underwent elective laparoscopic low anterior resection with double stapling technique (DST) anastomosis in our institution. Patients with allergic sensitivity to iodine
were excluded.

Participant flow

To investigate the pure risk factors of AL, cases with a protective stoma were excluded. In detail, six cases treated by preoperative chemoradiotherapy were not included, because a protective stoma was inevitably constructed. Finally, a total of 149 rectal cancer patients were included in this study.

Adverse events

There is no adverse event.

Outcome measures

1) Anastomotic leakage rate
2) Postoperative complications
3) identification of the factors associated with anastomotic leakage

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 01 Month 09 Day

Date of IRB

2013 Year 03 Month 22 Day

Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date

2020 Year 05 Month 28 Day

Date of closure to data entry

2020 Year 05 Month 28 Day

Date trial data considered complete

2020 Year 07 Month 06 Day

Date analysis concluded

2020 Year 11 Month 01 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 08 Day

Last modified on

2023 Year 01 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011405


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name