UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046046