UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026530 |
|---|---|
| Receipt number | 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 | 2021/07/30 19:32:06 |
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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 | Hiroyuki |
| Middle name | |
| Last name | Adachi |
Organization
Kanto Rosai Hospital
Division name
Department of General Thoracic Surgery
Zip code
211-8510
Address
1-1, Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Japan.
TEL
044-411-3131
adachi-fam@white.plala.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Adachi |
Organization
Kanto Rosai Hospital
Division name
Department of General Thoracic Surgery
Zip code
211-8510
Address
1-1, Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Japan
TEL
044-411-3131
Homepage URL
h_adachi_no2@yahoo.co.jp
Sponsor or person
Institute
Kanto Rosai Hospital
Institute
Department
Personal name
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
IRB of Kanto Rosai Hospital
Address
1-1, Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Japan
Tel
044-411-3131
keieikikaku@kantoh.johas.go.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
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
https://jtd.amegroups.com/article/view/54000/html
Publication of results
Published
Result
URL related to results and publications
https://jtd.amegroups.com/article/view/54000/html
Number of participants that the trial has enrolled
25
Results
This study showed the safety of use of INTEGRAN for staple-line coverage in pneumothorax surgery in young adults. The short-term recurrence rate was acceptable given the high-risk cohort examined in the study. A prospective randomized controlled study is needed for evaluation of the efficacy of INTEGRAN for prevention of recurrence of PSP.
Results date posted
| 2021 | Year | 07 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
25 patients (age <25 years old) with primary spontaneous pneumothorax (PSP) who underwent wedge resection with staple-line coverage with INTEGRAN between 2017 and 2020.
Participant flow
Among 27 patients, 25 patients consented to participate the study. All 25 patients received protocol treatment.
Adverse events
None
Outcome measures
The rate of material-related adverse events (defined as a body temperature >38 C continuing for >2 days, postoperative WBC >18,000/mm3 and/or CRP >15 mg/dL, or acute empyema within 30 postoperative days)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 13 | Day |
Last modified on
| 2021 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030443
