UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022318
Receipt number R000023975
Scientific Title Effects of preservation of celiac branch of the vagus nerve for the nutritional status after gastrectomy. A prospective randomized clinical trial.
Date of disclosure of the study information 2016/06/01
Last modified on 2023/05/21 09:27:34

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Basic information

Public title

Effects of preservation of celiac branch of the vagus nerve for the nutritional status after gastrectomy. A prospective randomized clinical trial.

Acronym

Preservation of celiac branch of the vagus nerve

Scientific Title

Effects of preservation of celiac branch of the vagus nerve for the nutritional status after gastrectomy. A prospective randomized clinical trial.

Scientific Title:Acronym

Preservation of celiac branch of the vagus nerve

Region

Japan


Condition

Condition

Early gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the nutritional impact of preserving the celiac branch of the vagus nerve on nutritional status after gastrectomy for early gastric cancer.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Primary endpoint:
The change of serum albumin, total protein, and hemoglobin one year after gastrectomy

Key secondary outcomes

Secondary endpoint:
1. The change of serum albumin, total protein, and hemoglobin two or three year after gastrectomy.
2. The change of serum albumin, total protein, and hemoglobin two or three year after gastrectomy according to operative procedure.
3. The change of body weight one, two, and three year after gastrectomy.
4. Operative time and blood loss
5. Short-term outcome
6. Assesment of clinical outocome using questionnaire one, two, and three year after gastrectomy


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Preservation of the celiac branch of the vagus nerve

Interventions/Control_2

No preservation of the celiac branch of the vagus nerve

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) The patients diagnosed as gastric adenocarcinoma with cT1N0
2) PS 0-1
3) Informed consent is obtained

Key exclusion criteria

1) Remnant gastric cancer
2) Gasrectomy with any other organs (not including gall bladder)
3) Any other malignancy which is including synchronal double cancer, but they are not including the carcinoma in situ or intramucosal cancer diagnosed as cure by local procedure
4) Severe respiratory disease
5) Severe cardiac disease
6) Severe hepatic cirrhosis or active hepatitis
7) Severe chronic renal failure
8) Patient who is judged as an inappropriate case by the doctor in charge

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Kohei
Middle name
Last name Wakatsuki

Organization

Nara Medical University

Division name

Surgery

Zip code

6348522

Address

840, Shijo-cho, Kashihara, Nara, Japan

TEL

0744-22-3051

Email

kohei@naramed-u.ac.jp


Public contact

Name of contact person

1st name Kohei
Middle name
Last name Wakatsuki

Organization

Nara Medical University

Division name

Surgery

Zip code

6348522

Address

840, Shijo-cho, Kashihara, Nara, Japan

TEL

0744-22-3051

Homepage URL


Email

kohei@naramed-u.ac.jp


Sponsor or person

Institute

Nara Medical University
Dep. of Surgery

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

Nara Medical University Ethics Committee

Address

840, Shijo-cho, Kashihara, Nara, Japan

Tel

0744223051

Email

ino_rinri@naramed-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

2016 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

56

Results


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



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2015 Year 12 Month 01 Day

Date of IRB

2016 Year 06 Month 13 Day

Anticipated trial start date

2016 Year 07 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 15 Day

Last modified on

2023 Year 05 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name