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