UMIN-CTR Clinical Trial

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
Email	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
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	IRB of Kanto Rosai Hospital
Address	1-1, Kizukisumiyoshi-cho, Nakahara-ku, Kawasaki, Japan
Tel	044-411-3131
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030443