UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023464 |
|---|---|
| Receipt number | R000026965 |
| Scientific Title | A randomized phaseII study to evaluate quality of life after total gastrectomy using a linear stapler vs a circular stapler for esophagojejunostomy |
| Date of disclosure of the study information | 2016/08/03 |
| Last modified on | 2024/03/04 11:21:38 |
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Basic information
Public title
A randomized phaseII study to evaluate quality of life after total gastrectomy using a linear stapler vs a circular stapler for esophagojejunostomy
Acronym
Laparoscopic esophagojejunostomy with linear or circular stapler
Scientific Title
A randomized phaseII study to evaluate quality of life after total gastrectomy using a linear stapler vs a circular stapler for esophagojejunostomy
Scientific Title:Acronym
Laparoscopic esophagojejunostomy with linear or circular stapler
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the superiority of the linear stapler compared with the circular stapler for esophagojejunostomy after total gastrectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Postgastrectomy syndrome at 12 months after operation (Complaint will be evaluated by EORTC QLQ-STO22)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Esophagojejunostomy is performed using a linear stapler.
Interventions/Control_2
Esophagojejunostomy is performed using a circular stapler.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histologically proven adenocarcinoma of the stomach
2. A total gastrectomy with curative intention is planned for gastric cancer located in the upper third of the stomach.
3. cStage I-III
4. No esophageal invasion
5. No gastric stump cancer
6. Sufficient oral intake, and continuous transfusion is not necessary
7. Simultaneous resection of organs other than the gallbladder and spleen is not planned.
8. Over 20 years old
9. Eastern clinical oncology group performance status is 0 or 1.
10. No previous chemotherapy or radiation therapy, including those for other cancers
11. Body mass index is less than 30.
12. Fulfills all of the following conditions
WBC>3,000/mm3
Plt>100,000/mm3
AST<100IU/L
ALT<100IU/L
T.Bil<2.0g.dl
Cre<1.5mg/dl
13. Written informed consent
Key exclusion criteria
1. Other active cancer
2. Active infectious disease
3. Possibly pregnant, or breast feeding woman
4. Psychiatric disorder
5. Receiving steroids
6. Acute myocardial infarction within 6 months or unstable angina
7. Uncontrolled hypertension
8. Uncontrolled diabetes mellitus and receiving insulin treatment
9. Pulmonary disease requiring continuous oxygen therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Terashima |
Organization
Shizuoka Cancer Center
Division name
Gastric Surgery
Zip code
411-8777
Address
1007,Shimonagakubo, Nagaizumi, Sunto, Shizuoka
TEL
055-989-5222
m.terashima@scchr.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Koseki |
Organization
Shizuoka Cancer Center
Division name
Gastric Surgery
Zip code
411-8777
Address
1007,Shimonagakubo, Nagaizumi, Sunto, Shizuoka
TEL
055-989-5222
Homepage URL
y.koseki@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
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
Shizuoka Cancer Center
Address
1007,Shimonagakubo, Nagaizumi, Sunto, Shizuoka
Tel
055-989-5222
rinsho_office@scchr.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 | 08 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 08 | 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 | 08 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026965
