UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040352
Receipt number R000046046
Scientific Title Multicenter Randomized Comparative Study of postsurgical recurrence of spontaneous pneumothorax: Bullae Resection versus Bullae Resection plus Polyglycolic Acid Sheet Coverage
Date of disclosure of the study information 2020/07/01
Last modified on 2021/05/11 19:51:58

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Basic information

Public title

PGA sheet's effect on the recurrence of spontaneous pneumothorax, Randomized trial

Acronym

PANDA trial

Scientific Title

Multicenter Randomized Comparative Study of postsurgical recurrence of spontaneous pneumothorax: Bullae Resection versus Bullae Resection plus Polyglycolic Acid Sheet Coverage

Scientific Title:Acronym

PANDA trial

Region

Japan


Condition

Condition

Primary spontaneous pneumothorax

Classification by specialty

Chest surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of PGA sheet coverage for the prevention of postoperative recurrence.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Rates of ipsilateral pneumothorax recurrence detected by radiography

Key secondary outcomes

Complication rates, surgical duration, blood loss, Reoperation rate for recurrent pneumothorax


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

VATS bullectomy only.

Interventions/Control_2

PGA sheet coverage on the staple line of VATS bullectomy

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

40 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients who have spontaneous pneumothorax diagnosed by radiography and plan to underwent VATS bullectomy.
2)Patients who receive informed consent to attend this study, and the agreements are provided in a document.
The consent of parents are also required, in case patients are under 20-years old.

Key exclusion criteria

1) Patients with allergy to polyglycol acid.
2) History of ipsilateral chest surgery.
3) History of ipsilateral pleurodesis or autologous blood patch pleurodesis.
4) Patients with infections requiring active treatment
5) Pregnant or breast-feeding patients.
6) Patients who are judged ineligible by the investigator and the attending surgeon.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Chen
Middle name
Last name Yoshikawa

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Thoracic Surgery

Zip code

466-8560

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2375

Email

tyoshikawa@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Yuka
Middle name
Last name Kadomatsu

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Thoracic Surgery

Zip code

466-8560

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2375

Homepage URL


Email

ykadomatsu@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan

Institute

Department

Personal name



Funding Source

Organization

Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Gifu Prefectural Tajimi Hospital
Shimada Municipal Hospiptal

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagoya University Hospital Institutional review board

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

Tel

052-744-1958

Email

center@med.nagoya-u.ac.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

名古屋大学病院(愛知県)、県立多治見病院(岐阜県)、市立島田市民病院(静岡県)


Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 01 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

Preinitiation

Date of protocol fixation

2020 Year 05 Month 10 Day

Date of IRB


Anticipated trial start date

2021 Year 12 Month 01 Day

Last follow-up date

2026 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 05 Month 10 Day

Last modified on

2021 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046046


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name