UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000024987
Receipt number	R000028751
Scientific Title	Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection
Date of disclosure of the study information	2016/11/24
Last modified on	2017/05/26 14:34:11

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Basic information

Public title

Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection

Acronym

Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection

Scientific Title

Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection

Scientific Title:Acronym

Phase II clinical trial of pleurodesis with a 50% glucose solution for persistent air leak after pulmonary resection

Region

Japan

Condition

Postoperative persistent air leak or postoperative pneumothorax after pulmonary resection

Classification by specialty

Chest surgery

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Treatment for postoperative persistent air leak or postoperative pneumothorax is drainage, pleudolesis or operation. In Japan OK-432 has been used as pleurodesis routinely, however anaphylaxis and acute exacerbation of interstitial pneumonia has been reported as the adverse events. Otherwise the indication for the pleurodesis with OK-432 is for malignant pleural effusion. The drug price is about 7,000 yen and so expensive. Therefore safe and low-cost drug is expected. Pleurodesis with a 50% glucose solution has been reported for several years. The treatment cause hyperglycemia, however it has been reported as the safe and low-cost treatment. On the other hand there is no prospective study about the effect and adverse events and we planed this study.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Assessment

Primary outcomes

Rate of stopping air leakage after pleurodesis with a 50% glucose solution

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

50% glucose solution group

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

Postoperative persistent air leak or postoperative pneumothorax after pulmonary resection

Key exclusion criteria

1) Patients with poor general condition caused by disease such as severe infection
2) Pregnant, breastfeeding , sexually active woman, or patients with no contraception.
3) Patients with severe diabetes mellitus
4) Patients registration to this study is deemed difficult due to mental disorders clinically relevant
5) Considered to be inappropriate for the participation in this study by the investigators
6) Patients unwilling to sign the consent form for participation

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Yasushi Mizukami

Organization

Hokkaido Cancer Center

Division name

Department of thoracic surgery

Zip code

Address

2-3-54, Kikusui 4-jo, Shiroishi-ku Sapporo-shi, Hokkaido, 003-0804, Japan

TEL

011-811-9111

Email

mizukami@sap-cc.go.jp

Public contact

Name of contact person

1st name

Middle name

Last name Yasushi Mizukami

Organization

Hokkaido Cancer Center

Division name

Department of thoracic surgery

Zip code

Address

2-3-54, Kikusui 4-jo, Shiroishi-ku Sapporo-shi, Hokkaido, 003-0804, Japan

TEL

011-811-9111

Homepage URL

Email

mizukami@sap-cc.go.jp

Sponsor or person

Institute

Hokkaido Cancer Center

Institute

Department

Personal name

Funding Source

Organization

Hokkaido Cancer Center

Organization

Division

Category of Funding Organization

Other

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 24 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

2016 Year 10 Month 14 Day

Date of IRB

Anticipated trial start date

2016 Year 10 Month 14 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

2016 Year 11 Month 24 Day

Last modified on

2017 Year 05 Month 26 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028751

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name