UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective Randomized Trial of the Effectiveness of Managing Postoperative Air Leak between Electronic Versus Traditional Chest Drainage System in Pulmonary Resection
Title of the study (Brief title)	Prospective Randomized Trial of the Effectiveness of Managing Postoperative Air Leak between Electronic Versus Traditional Chest Drainage System in Pulmonary Resection
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study was to confirm the superiority of a test treatment group using a digital monitoring thoracic drainage system (Thopaz group) to a current clinical standard of care group using a conventional water seal or continuous suction thoracic drainage (conventional thoracic drainage group) in patients undergoing pulmonary resection associated with more than segmentectomy excluding pneumonectomy, using a randomized comparative study of the duration of postoperative drain placement (enable for earlier removal of drain).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Duration of drain placement (days)
Key secondary outcomes	Percent occurrence of intraoperative air leak (at the time of the first postoperative leak test), frequency of intraoperative sealant use and its type, percent occurrence of postoperative air leak (at the time of entering postoperative recovery room or ICU), duration of postoperative air leak (days), frequency of postoperative pleurodesis, days of hospitalization (days), and percent occurrence of postoperative adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Patients using Thopaz
Interventions/Control_2	Conventional drainage group
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have no history of ipsilateral lung surgery, scheduled to undergo pulmonary resection associated with more than segmentectomy excluding pneumonectomy, and fulfill below criteria are eligible. 1)Patients scheduled to undergo pulmonary resection associated with more than segmentectomy excluding pneumonectomy 2)More than 800 mL of predicted postoperative forced expiratory volume in one second (ppoFEV1) (ppoFEV1 = Preoperative FEV1 x (number of segment - number of segment to be resected)/number of segment) 3)Performance Status 0-1 (ECOG classification) 4)Above 20 years old 5)Consent from the patient for participating in the study is obtained
Key exclusion criteria	1)Has previously undergone ipsilateral lung surgery 2)Has an active lung infection (bacterial infection or fungal infection) 3)Undergoing continuing systemic administration (oral or intravenous) of steroids 4)Complicated by uncontrolled diabetes mellitus (Uncontrolled: urinary glucose of 10 g or more per day or fasting blood glucose of 150 mg/dL or more even under insulin treatment) 5)Requiring anticoagulant therapy (continuous intravenous drip of heparin) in the perioperative period 6)Patient participation in the study is judged difficult due to complications related to a psychiatric disorder or psychological symptoms 7)Judged unsuitable for study participation by the investigator for any other reason
Target sample size	300

Research contact person
Name of lead principal investigator	Kenji Suzuki
Organization	Juntendo University School of Medicine
Division name	General Thoracic Surgery
Address	1-3, Hongo 3-chome, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL	03-3813-3111
Email	kjsuzuki@juntendo.ac.jp

Public contact
Name of contact person	Kazuya Takamochi
Organization	Juntendo University School of Medicine
Division name	General Thoracic Surgery
Address	1-3, Hongo 3-chome, Bunkyo-ku, Tokyo, 113-8431, Japan
TEL	03-3813-3111
Homepage URL
Email	ktakamo@juntendo.ac.jp

Sponsor
Institute	General Thoracic Surgery, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	Medela AG
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Switzerland

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 12 Day
Anticipated trial start date	2015 Year 02 Month 10 Day
Last follow-up date	2016 Year 08 Month 03 Day
Date of closure to data entry	2016 Year 08 Month 03 Day
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 03 Month 05 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019365