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
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
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
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
