UMIN-CTR Clinical Trial

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

spontaneous pneumothorax

Classification by specialty

Pneumology

Chest surgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kanto Rosai Hospital

Institute

Department

Personal name

Organization

Japan Organization of Occupational Health andSafety

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2017

Year

03

Month

14

Day

URL releasing protocol

https://jtd.amegroups.com/article/view/54000/html

Publication of results

Published

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

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 related 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