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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026530
Receipt No. R000030443
Scientific Title Feasible study on use of sheet-type absorbable topical collagen hemostat (press-sheet type Integran(R)) for prevention of postoperative recurrence of pneumothorax in young patients.
Date of disclosure of the study information 2017/03/14
Last modified on 2019/07/13

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Basic information
Public title Feasible study on use of sheet-type absorbable topical collagen hemostat (press-sheet type Integran(R)) for prevention of postoperative recurrence of pneumothorax in young patients.
Acronym Feasible study on use of sheet-type absorbable topical collagen hemostat (press-sheet type Integran(R)) for prevention of postoperative recurrence of pneumothorax in young patients.
Scientific Title Feasible study on use of sheet-type absorbable topical collagen hemostat (press-sheet type Integran(R)) for prevention of postoperative recurrence of pneumothorax in young patients.
Scientific Title:Acronym Feasible study on use of sheet-type absorbable topical collagen hemostat (press-sheet type Integran(R)) for prevention of postoperative recurrence of pneumothorax in young patients.
Region
Japan

Condition
Condition spontaneous pneumothorax
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of sheet-type absorbable topical collagen hemostat (Press-sheet type Integran(R)) using for prevention of postoperative recurrence of pneumothorax in patients under 25-year old.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Occurrence proportion of sheet-related adverse events.

(Seat-related adverse events are defined as
either
A) Fever of 38 degree Celsius or more that continues for at least 2 days occurring by the end of protocol treatment
B) Abnormal inflammatory reactions with WBC > 18000/mm^3 or CRP > 15 mg/dl occurring by the end of protocol treatment
C) Postoperative acute empyema occurring within 30 days after surgery)
Key secondary outcomes (1)Postoperative recurrence rate of pneumothorax
(2)Occurence proportion of newly occured bullae around resected site at 12 months after surgery

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 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 After the bulla causing the pneumotorax is resected by linear stapler, both edge of staple-line are ligated by polydioxanone sutures. Then, the staple-line is covered by "press-sheet type Integran(R)(100x50mm size)", followed by fixtation of the sheet using the sutures on the staple edge.
After the day after surgery, the drainage tube is removed when investigator identify the stop of air leakage and decrease of drainage amount less than 200 ml/day. The protocol treatment is finished on the next day of drainage tube removal, with verifying no collapse sign of lung on chest X-ray.
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
16 years-old <=
Age-upper limit
25 years-old >=
Gender Male and Female
Key inclusion criteria (1)The patients between 16 to 25 years old.
(2)With the diagnosis of primary spontaneous pneumothorax.
(3)With the operative criteria described below and with use of linear stapler to resect bullae.
a)Cases in which relapse is repeated with conservative treatment
b)Cases with prolonged air leakage more than 1 week by conservative treatment
c)Cases combined with mild or moderate hemothorax
d)Cases not to achieve enough expansion of lung by continuous suction drainage.
e)Cases with social reason (ex. pilot, diver)
(4)Meet all requirements described below by blood examination.
a)WBC >3000 and <12,000 /mm^3
b)CRP <3.0 mg/dL
c)Hb >8.0 g/dL
d)Plt > 100,000 /mm^3
e)AST <100 IU/L
f)ALT <100 IU/L
g)T-bil <2.0 mg/dL
h)Cr <1.5 mg/dL
i)Alb > 3.0 g/dL
(5)With ECOG PS score 0 or 1
(6)With consent to enroll the study (especially, consents are needed from both patient and his/her parent when patients are less than 20-year old).
Key exclusion criteria (1)Secondary spontaneous pneumothorax patients
(2)Synchronous bilateral pneumothorax patients
(3)Patients with shock vital sign (Systolic blood pressure <80 mmHg and HR > 100 bpm) or with hemothorax more than 1,000 ml
(4)With medical history of ipsilateral thoracic surgery.
(5)Patients with hypersensitivity to bovine derived products (insulin, glucagon etc.)
(6)Patients with pregnancy
(7)Patients who are assessed by investigator as "inadequate for enrollment" .
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Adachi
Organization Kanto Rosai Hospital
Division name Department of General Thoracic Surgery
Zip code
Address 1-1, Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Japan.
TEL 044-411-3131
Email adachi-fam@white.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Adachi
Organization Kanto Rosai Hospital
Division name Department of General Thoracic Surgery
Zip code
Address 1-1, Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Japan
TEL 044-411-3131
Homepage URL
Email h_adachi_no2@yahoo.co.jp

Sponsor
Institute Kanto Rosai Hospital
Institute
Department

Funding Source
Organization Japan Organization of Occupational Health andSafety
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 独立行政法人労働者健康安全機構 関東労災病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 14 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
2017 Year 01 Month 30 Day
Date of IRB
2017 Year 01 Month 30 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2020 Year 07 Month 03 Day
Date of closure to data entry
Date trial data considered complete
2020 Year 09 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 13 Day
Last modified on
2019 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030443

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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