UMIN-CTR Clinical Trial

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

Benign or malignant pulmonary lesions

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kanagawa Cancer Center
Department of Thoracic Surgery

Institute

Department

Personal name

Organization

Covidien Japan Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

10

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

10

Month

03

Day

Last modified on

2014

Year

10

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007524