UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023464
Receipt No. 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 2020/08/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email m.terashima@scchr.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Kamiya
Organization Shizuoka Cancer Center
Division name Gastric Surgery
Zip code 411-8777
Address 1007,Shimonagakubo, Nagaizumi, Sunto, Shizuoka
TEL 055-989-5222
Homepage URL
Email sat.kamiya@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

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
Email rib@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
2020 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026965

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.