UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000013652
Receipt number	R000015934
Scientific Title	Effect of laparoscopic distal gastrectomy with preservation of the celiac branch of the vagus nerve
Date of disclosure of the study information	2014/04/15
Last modified on	2019/04/11 15:33:09

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Basic information

Public title

Effect of laparoscopic distal gastrectomy with preservation of the celiac branch of the vagus nerve

Acronym

Preservation of celiac branch of vagus nerve

Scientific Title

Effect of laparoscopic distal gastrectomy with preservation of the celiac branch of the vagus nerve

Scientific Title:Acronym

Preservation of celiac branch of vagus nerve

Region

Japan

Condition

Early gastric cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To evaluate the effects of laparoscopic distal gastrectomy for early gastric cancer with preservation of the celiac branch of the vagus nerve on gastrointestinal function and glucose tolerance.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Primary endpoint: gastrointestinal function after surgery

Key secondary outcomes

Secondary endpoint: Time to first appearance of defecation, volume of food intake, glucose tolerance (HbA1c)

Base

Study type

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Laparoscopic distal gastrectomy with preservation of the celiac branch of the vagus nerve

Interventions/Control_2

Laparoscopic distal gastrectomy without 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 indications for laparoscopic distal gastrectomy included the following: depth of tumor invasion limited to the mucosa or submucosa, absence of lymph node metastases in preoperative examinations, and a neoplasm of any histologic type.
2) PS 0-1
3) Inclusion criteria were as follows: a white blood cell count between 4000 and 8000 mm3; Hb level of over 10g/dl, a platelet count of over 10000 mm3, aspartate aminotransferase and alanine aminotransferase levels within 1.5 times the upper limit of normal for the institution; a serum bilirubin level of less than 1.5 mg dl; a serum creatinine level less than 1.2 mg/dl; BUN level less than 25 mg/dl; HbA1c level less than 6.

Key exclusion criteria

1) Presence of cardiac dysfunction, liver and renal failure.
2) Presence of ascites
3) Unsatisfactory respiratory status
4) Presence of active infectious disease
5) Pregnancy
6) History of allergic reaction for drugs

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Erito Mochiki

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Digestive Tract and General Surgery

Zip code

Address

1981 Kamoda, Kawagoe, Saitama, Japan

TEL

049-228-619

Email

emochiki@saitama-med.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Erito Mochiki

Organization

Saitama Medical Center, Saitama Medical University

Division name

Department of Digestive Tract and General Surgery

Zip code

Address

1981 Kamoda, Kawagoe, Saitama, Japan

TEL

049-228-619

Homepage URL

http://www.saitama-med.ac.jp/kawagoe/05others/chiken/index.html

Email

emochiki@saitama-med.ac.jp

Sponsor or person

Institute

Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name

Funding Source

Organization

Saitama Medical Center, Saitama Medical 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

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2014 Year 04 Month 15 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

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

Completed

Date of protocol fixation

2013 Year 12 Month 06 Day

Date of IRB

2014 Year 01 Month 10 Day

Anticipated trial start date

2014 Year 04 Month 15 Day

Last follow-up date

2016 Year 03 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

2014 Year 04 Month 06 Day

Last modified on

2019 Year 04 Month 11 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015934

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name