UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020414
Receipt number R000023576
Scientific Title The evaluation of the gastric blood flow for status pre/post distal pancreatectomy with en-bloc celiac axis resection and left gastric artery reconstruction using indocyanine green angiography
Date of disclosure of the study information 2016/01/01
Last modified on 2022/07/07 18:24:36

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Basic information

Public title

The evaluation of the gastric blood flow for status pre/post distal pancreatectomy with en-bloc celiac axis resection and left gastric artery reconstruction using indocyanine green angiography

Acronym

The evaluation of the gastric blood flow after left gastric artery reconstruction using indocyanine green angiography

Scientific Title

The evaluation of the gastric blood flow for status pre/post distal pancreatectomy with en-bloc celiac axis resection and left gastric artery reconstruction using indocyanine green angiography

Scientific Title:Acronym

The evaluation of the gastric blood flow after left gastric artery reconstruction using indocyanine green angiography

Region

Japan


Condition

Condition

Patients who will undergo distal pancreatectomy with celiac axis en-bloc resection and reconstruction of left gastric artery. The category of resection or preservation of left inferior phrenic artery is not divided.

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to elucidate the safety and the efficacy of evaluation of stomach blood flow for status pre/post distal pancreatectomy with en-bloc celiac axis resection and left gastric artery reconstruction using indocyanine green angiography. We will identify the risk factor of ischemic gastropathy by measuring and categorizing pattern of ICG which is difficult to evaluate by usual observation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cut off ICG value to identify and categorize patterns of safe stomach blood flow after recontruction of left gastric artery including Tmax, T1/2, and Imax.

Key secondary outcomes

1)The incidence of ischemic gastropathy by resection or preservation of left inferior phrenic artery.
2)The incidence of delayed gastric emptying.
3)The incidence of gastric ulcer.


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

Medicine

Interventions/Control_1

The evaluation of the gastric blood flow for status pre/post distal pancreatectomy with en-bloc celiac axis resection and left gastric artery reconstruction using indocyanine green angiography.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who need evaluation of the gastric blood flow for status pre/post distal pancreatectomy with en-bloc celiac axis resection and left gastric artery reconstruction.

Key exclusion criteria

1) Patients who have allergy to isodine contrast media.
2) Patients who have surgical history of colon or rectum, since left gastric artery will be reconstructed by middle colic artery.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Ken-ichi
Middle name
Last name Okada

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

641-8510

Address

Kimiidera 811-1, Wakayama City

TEL

073-441-0613

Email

yamaue-h@wakayama-med.ac.jp


Public contact

Name of contact person

1st name Ken-ichi
Middle name
Last name Okada

Organization

Wakayama Medical University

Division name

Second Department of Surgery

Zip code

641-8510

Address

Kimiidera 811-1, Wakayama City

TEL

073-441-0613

Homepage URL


Email

okada@wakayama-med.ac.jp


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Wakayama Medical University

Address

Kimiidera 811-1, Wakayama City

Tel

+81734410613

Email

wa-rinri@wakayama-med.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

2016 Year 01 Month 01 Day


Related information

URL releasing protocol

Gastrointest Tumors. 2017;4(1-2):28-35. doi: 10.1159/000469660.

Publication of results

Published


Result

URL related to results and publications

Gastrointest Tumors. 2017;4(1-2):28-35. doi: 10.1159/000469660.

Number of participants that the trial has enrolled

3

Results

safety was confirmed in 3 patients.

Results date posted

2022 Year 07 Month 07 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2017 Year 04 Month 12 Day

Baseline Characteristics

Patients who undergo distal pancreatectomy with celiac axis en-bloc resection.

Participant flow

Enrollment
Surgery
Assessment

Adverse events

None

Outcome measures

Safety

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 12 Month 18 Day

Date of IRB

2016 Year 01 Month 14 Day

Anticipated trial start date

2016 Year 01 Month 14 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry

2019 Year 12 Month 31 Day

Date trial data considered complete

2019 Year 12 Month 31 Day

Date analysis concluded

2019 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 01 Month 01 Day

Last modified on

2022 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023576


Research Plan
Registered date File name
2022/07/07 Gastroinestinal Tumors 2017 MCA-LGA bypass.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name