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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040352
Receipt No. 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 2020/05/11

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

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
2020 Year 07 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
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.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


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