UMIN-CTR Clinical Trial

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
Condition	Early gastric cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

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	2
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	60

Research contact person
Last 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
1st 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
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015934