UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036675 |
|---|---|
| Receipt number | R000036918 |
| Scientific Title | Feasibility of efficacy and safety of double-tract reconstruction after laparoscopic proximal gastrectomy for gastric cancer: a phase II study |
| Date of disclosure of the study information | 2019/05/08 |
| Last modified on | 2019/05/08 11:03:37 |
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Basic information
Public title
Feasibility of efficacy and safety of double-tract reconstruction after laparoscopic proximal gastrectomy for gastric cancer: a phase II study
Acronym
LPG double tract
Scientific Title
Feasibility of efficacy and safety of double-tract reconstruction after laparoscopic proximal gastrectomy for gastric cancer: a phase II study
Scientific Title:Acronym
LPG double tract
Region
| Japan |
Condition
Condition
Gastric cancer in the upper third
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety in double-tract reconstruction after laparoscopic proximal gastrectomy for gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight loss rate 6 months after surgery
Key secondary outcomes
Surgical process (operative time, intraoperative bleeding, the number of ports, the use of the saturation, cost, the rates of laparotomy transition), postoperative course (oral intake, length of stay, inflammatory findings, the rates of late complications, stenosis, usage rate of PPI, incidence rate of GERD).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Laparoscopic proximal gastrectomy with double-tract reconstruction
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically proven gastric carcinoma in the upper third
2. Performance status 0 and 1
3. Aged 20 to 85 year
4. No history of surgery for gastric cancer (Endoscopic treatment is tolerant)
5. Plt => 100,000/mm3
Creatinine <= 2.0 mg/dl
AST <= 200 IU/L
ALT <= 200 IU/L
T-bil <= 2.0 mg/dl
Hb => 8.0 g/dl
6. Patients who gave written informed consent before entry in this study
Key exclusion criteria
1. Ischemic heart disease
2. Liver cirrhosis, active hepatitis
3. Interstitial pneumonia
4. Haemodialysis
5. Both malignant disorder
6. Severe abdominal adhesion
7. Doctor's decision not to register to this regimen
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department of Surgery
Zip code
641-8510
Address
Kimiidera 811-1, Wakayama
TEL
0734410613
tojima@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Ojima |
Organization
Wakayama Medical University School of Medicine
Division name
Second Department of Surgery
Zip code
641-8510
Address
Kimiidera 811-1, Wakayama
TEL
0734410613
Homepage URL
tojima@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University, School of Medicine, Second Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University, School of Medicine, Second Department of Surgery
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
Wakayama Medical University Hospital
Address
811-1 Kimiidera, Wakayama
Tel
0734410613
tojima@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
| 2019 | Year | 05 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 05 | Month | 08 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036918
