UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006462
Receipt No. R000007524
Scientific Title A Prospective Single-center Observational study on the Efficacy and Safety of the Endo GIA Tri-Staple in patients with Pulmonary Resection
Date of disclosure of the study information 2011/10/05
Last modified on 2014/10/03

* 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 Prospective Single-center Observational study on the Efficacy and Safety of the Endo GIA Tri-Staple in patients with Pulmonary Resection
Acronym A Prospective Single-center Observational study on the Efficacy and Safety of the Endo GIA Tri-Staple in patients with Pulmonary Resection
Scientific Title A Prospective Single-center Observational study on the Efficacy and Safety of the Endo GIA Tri-Staple in patients with Pulmonary Resection
Scientific Title:Acronym A Prospective Single-center Observational study on the Efficacy and Safety of the Endo GIA Tri-Staple in patients with Pulmonary Resection
Region
Japan

Condition
Condition Benign or malignant pulmonary lesions
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of Endo GIA Tri-Staple, a surgical stapler that was newly introduced to clinical practice.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Incidence of prolomged air leaks (pulmonary fistula) that continue for more than five postoperative days
Key secondary outcomes Incidence of air leaks occurring in the cut end during operation, incidence and degree of damage to the pleura, staple formation, haemostatic effect on the staple line, presence or absence of additional suture, whether or not sealing technique is applied and applied procedure, incidence of perioperative and postoperative adverse events, duration of placement of drain, duration of hospitalization (days)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Endo GIA Tri-Staple
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pulmonary resection (excluding pneumonectomy) using surgical stapler is scheduled (regardless of cancer or non-cancer).
2) 20 years old or older (no upper limit)
3) No past history of ipsilateral thoracotomy
4) No past history of radiation therapy in the chest
5) No past history of chemotherapy with anticancer agent/s
6) Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) of either 0 or 1
7) Written informed consent is obtained from the patient him/herself.
Key exclusion criteria 1) Patients who are scheduled for a lobectomy and who are found to have a complete interlobar fissure when the chest is opened (surgical stapler is not needed for interlobar separation)
2) Patients in which factors predicting non-curable resection for lung cancer, such as pleural dissemination and malignant pleural effusion, are observed when the chest is opened
3) Patients who are complicated by active infection that requires treatment other than external medicine
4) Patients who continue on systemic steroid preparation (oral or intravenous) until the day of the operation
5) Patients who are complicated by poorly controlled diabetes mellitus (HbA1C>8.0)
6) Functions of the main organs are not maintained (Common terminology criteria for adverse events (CTCAE) ver. 4.0 Grade>=2).
7) Patients with malignant pleural effusion or cardiac effusion
8) Patients who are complicated by psychiatric disorders or psychiatric symptoms and who are judged to have difficulties in participating in the study
9) Other patients who are considered by the investigator or sub-investigator as not suitable for participation in this study
Target sample size 59

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruhiko Nakayama
Organization Kanagawa Cancer Center
Division name Department of Thoracic Surgery
Zip code
Address 1-2 Nakao 1-chome, Asahi-ku, Yokohama City, Kanagawa, 241-8515
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Tsuboi
Organization Kanagawa Cancer Center
Division name Department of Thoracic Surgery
Zip code
Address 1-2 Nakao 1-chome, Asahi-ku, Yokohama City, Kanagawa, 241-8515
TEL 045-391-5761
Homepage URL
Email

Sponsor
Institute Kanagawa Cancer Center
Department of Thoracic Surgery
Institute
Department

Funding Source
Organization Covidien Japan Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 Year 10 Month 05 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
2011 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 10 Month 03 Day
Last modified on
2014 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007524

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.