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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025160
Receipt No. R000028187
Scientific Title A phase III study of delta-shaped linear stapler anastomosis versus circular stapler anastomosis for patients with lower third gastric cancer.
Date of disclosure of the study information 2016/12/21
Last modified on 2019/11/07

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Basic information
Public title A phase III study of delta-shaped linear stapler anastomosis versus circular stapler anastomosis for patients with lower third gastric cancer.
Acronym A phase III study of delta anastomosis
Scientific Title A phase III study of delta-shaped linear stapler anastomosis versus circular stapler anastomosis for patients with lower third gastric cancer.
Scientific Title:Acronym A phase III study of delta anastomosis
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate the superiority of the Delta-shaped anastomosis in laparoscopic distal gastrectomy with Billroth I reconstruction for cStage I gastric cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes The number of use of analgesics in three days after surgery.
Key secondary outcomes Incidence rate of anastomotic leakage, Reconstruction time, QOL after surgery, Complication rate, The number of dissected lymph nodes, Estimated blood loss, Body temperature the highest in postoperative period, Days to first flatus, Postoperative levels of inflammatory makers, Postoperative hospital stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Laproscopy-assisted distal gastrectomy with delta-shaped anastomosis
Interventions/Control_2 Laproscopy-assisted distal gastrectomy with circular stapler anastomosis
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically proven gastric cancer
2) Diagnosed as cStageI by endoscopy and contrast enhanced CT
3) Regarded as curatively resected by distal gastrectomy with Billroth I reconstruction with the tumor location of the L area
4) Informed consent obtained from the patient
Key exclusion criteria 1) Continuous steroid use (oral or intravenous)
2) With myocardial infarction in 6 months or with unstable angina
3) With uncontrollable hypertension
4) With uncontrollable diabetes mellitus
5) With respiratory disorder requiring continuous oxgen therapy
6) Unable to discontinue anti-coagulant drugs.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Watanabe
Organization Kitasato University
Division name Department of surgery
Zip code 2520374
Address 1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Email gekaw@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Kei
Middle name
Last name Hosoda
Organization Kitasato University
Division name Department of surgery
Zip code 2520374
Address 1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Homepage URL
Email k.hosoda@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato 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 Research Ethics Committee of the Kitasato University School of Medicine
Address 1-15-1 Kitasato, Sagamihara, Japan
Tel 0427788111
Email rinrib@med.kitasato-u.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
2016 Year 12 Month 21 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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 02 Day
Date of IRB
2016 Year 12 Month 01 Day
Anticipated trial start date
2016 Year 12 Month 21 Day
Last follow-up date
2021 Year 10 Month 01 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 12 Month 06 Day
Last modified on
2019 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028187

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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