Postoperative Air LeakNCT02502643
The Efficacy of OK-432 Pleurodesis on Postoperative Air Leak
A study testing OK-432 pleurodesis and normal saline pleurodesis in people with Postoperative Air Leak, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is (1) The success rate of OK-432 pleurodesis after thoracic surgery that air leak over 48 hours (2)The side effects and treatments of OK-432 pleurodesis. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Postoperative Air Leak
- What is being tested?
- OK-432 pleurodesis and normal saline pleurodesis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were eligible for this study if they were more than 20 and less than 70 years old of age and under thoracic surgery that air leak lasting more than 48 hours form chest drainage bottles.
Who cannot join
- penicillin allergy, primary pneumothorax, esophageal cancer, immune dysfunction, those who can not sign a consent form, and pregnant or lactating, other serious concomitant illness such as uremia or liver cirrhosis.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Test2, test3
Jin-Shing Chen, 886-2-23123456 ext. 65178, chenjs@ntu.edu.tw
About this study
The purpose of this study is (1) The success rate of OK-432 pleurodesis after thoracic surgery that air leak over 48 hours (2)The side effects and treatments of OK-432 pleurodesis.
[Methods] This study was a prospective, randomized, open-label, controlled study to evaluate the effectiveness of OK-432 pleurodesis of persistent air Leak after pulmonary Resection. The adult patient have persistent air leak >48 hours after thoracic surgery, will randomized to OK-432 pleurodesis (OK-432 group) or normal saline pleurodesis (NS group). The trial will be conduct from May 25, 2015 to May 25, 2018 in the Department of Surgery at national Taiwan University Hospital, a medical center. The study protocol was approved by the hospitals' Institutional Review Boards. A total of 80 cases, the subjects will be the hospital thoracic surgery ward and received outpatient programs. Eligible Subjects : adults (minimum age> 20 years; maximum age ≦ 70 years old) patients with thoracic surgery and over48 hours of continuous air leak. The exclusion criteria include: penicillin allergy,primary pneumothorax, esophageal cancer, immune dysfunction, those who can not sign a consent form, and pregnant or lactating, other serious concomitant illness such as uremia or liver cirrhosis. Study steps: eligible Patients will randomize according to computer-generated random numbers, with 1:1 ratio in sequentially numbered, sealed envelopes by a study nurse who was masked to the study. Randomization envelopes were opened, and randomization was performed by the study nurse after informed consent was obtain. Eligible inpatients were randomized to the OK-432 group or the normal saline (NS) group，each group are 40 cases.
Read more
All subjects were observed by the physician who was masked to the study， about air leak stop time, chest tube removal time, discharge time, outpatient chest X-ray, pulmonary function tests as necessary. cases if persistent air leak more than seven days, the attending physician determines whether pleurodesis again or surgery or other medical treatment. Finally, the researcher who do not know groups will collection data by "air leak case record form" including diagnosis, surgical site，the start and end time of the surgery, the use of antibiotics, discomfort problems (pain , stomach discomfort, cough, fever> 38 ℃, allergic reactions and respiratory discomfort), postoperative air leak time, air leak stop time , chest tube removal time, discharge time, the data will be use SPSS20.0 version of the statistical software package, and T-test, pair T-test ，Anova ,linear correlation statistical methods for analysis.
Outcome measures: OK-432 success rate, OK-432 side effects, air leak time, chest tube remove time, length of hospital stay.
Read the detailed description
[Background and Objective] :Air leak produced after thoracic surgery is a common phenomenon.Prolonged chest tube placement can lead to empyema or infection, and extended hospitalization or even death. In 2010 many researchers reported that The incidence of lung resection produce air leak about 8-26% (Singhal et al., 2010), and even up to 50% (Mueller \& Marzluf, 2014).How to effectively treatment is still not clear.The chemical pleurodesis is an effective option in management of air leak.There are several chemical agents for pleurodesis, such as tetracycline and minocycline, talc, Taurolidine, bleomycin, iodopovidone, picibanil (OK-432), silver nitrate, quinacrine. What kind of chemical agent effective remain controversial. A study evaluated after thoracoscopic operation for primary spontaneous pneumothorax the safety and efficacy of chemical pleurodesis with a comparison between minocycline and OK-432. The OK-432 pleurodesis (19 patients) as the primary treatment and the primary success rate was 95%.(How et al., 2014).Another retrospective case-control study examining post-isolated lobectomies and bilobectomies by thoracotomy of Persistent air leak，sclerosis (talc, bleomycin, minocycline, doxycycline)for the treatment of prolonged air leak was successful in 40 of 41 patients (the success rate of 97.6%) (Liberman et al., 2010). The prolonged air leaks after major pulmonary resection still no empirical treatment of clinical research.
Hypothesis: patients were persistent air leak after 48 hours chest surgery will perform OK-432 pleurodesis .The chest tube time can reduce and length of hospital stay. Extended applications can significantly reduce medical costs and manpower, and to explore OK -432 pleurodesis side effects and treatment.
- Conditions
- Postoperative Air Leak
- Being tested
- OK-432 pleurodesis, normal saline pleurodesis
- Keywords
- Safety and Efficacy, Thoracic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OK-432 pleurodesisDrug
Also called Picibanil
1.Pain medications (if no contraindications) Before half hour; Bain (IM ,0.15mg / kg). 2. Make the patient supine position 3. Near the body of patient's chest tube is the injection site disinfection with the alcoholic Betadine and alcohol repeated three times.4. 20 cc of 2% lidocaine hydrochloride (400 mg) was instilled into the pleural cavity through the chest tube 5. A solution of 30 cc of normal saline containing 5 KE of OK-432 (KE Z Klinische Einbeit; 1 KE contains 0.1 mg of dried cocci).6. Inject air 20 cc 7. The injection site will cover with op site and the rubber tube that connecting the chest tube and chest bottle was raised 40-60 cm above the patient to trap the sclerosing agent but allow air to pass 8. Patients will reposition (left and right side)every 30 minutes in 2 hours
normal saline pleurodesisDrug
Also called normal saline
Make the patient supine position , Near the body of patient's chest tube is the injection site disinfection with the alcoholic Betadine and alcohol repeated three times.injected a solution of 30 cc of normal saline , and then injected into 20 cc air to the rubber chest tube , so that normal saline can completely into the chest, the injection site will cover with op site, use a rubber band to the rubber chest tube for hanging from the patient's body 40-60 cm high.Patients will reposition (left and right side)every 30 minutes in 2 hours
| Study group | Role | What they receive |
|---|---|---|
| OK-432 pleurodesis | Experimental | Picibanil ( OK-432 ) ,OK-432 (KE Z Klinische Einbeit; 1 KE contains 0.1 mg of dried cocci; UKIMA PLANT OF CHUGAI PHARMA MANUFACTURING CO, LTD; JAPAN). Receives: Drug: OK-432 pleurodesis |
| normal saline pleurodesis | Active comparator | (Normal Saline),Isotonic Sodium Chloride Solution Receives: Drug: normal saline pleurodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
OK-432 success rate
The success rate of OK-432 was defined chest bottle no bubbles appear when coughing, then CXR was perform the next day after pleurodesis, and after cessation of the air leak,the chest tube is remove .
Measured: 48 hours
Secondary outcomes (1)
OK-432 side effects
The main side effects of the procedure with OK-432 were fever and chest pain, which were well controlled by non-steroidal anti-inflammatory drugs.the side effects of OK-432 will be assessed by temperature,visual analog scale.these will present as number and frequencies (%).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Air LeakStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Shing Chen, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502643
- Sponsor's protocol ID
- 201504066RINA
- Status last verified
- Oct 2016
- First submitted
- 15 Jul 2015
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of OK-432 Pleurodesis on Postoperative Air Leak
- ClinicalTrials.gov ID
- NCT02502643
- Acronym / sponsor ID
- 201504066RINA
- Conditions
- Postoperative Air Leak
- Keywords
- Safety and Efficacy, Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is (1) The success rate of OK-432 pleurodesis after thoracic surgery that air leak over 48 hours (2)The side effects and treatments of OK-432 pleurodesis.
[Methods] This study was a prospective, randomized, open-label, controlled study to evaluate the effectiveness of OK-432 pleurodesis of persistent air Leak after pulmonary Resection. The adult patient have persistent air leak >48 hours after thoracic surgery, will randomized to OK-432 pleurodesis (OK-432 group) or normal saline pleurodesis (NS group). The trial will be conduct from May 25, 2015 to May 25, 2018 in the Department of Surgery at national Taiwan University Hospital, a medical center. The study protocol was approved by the hospitals' Institutional Review Boards. A total of 80 cases, the subjects will be the hospital thoracic surgery ward and received outpatient programs. Eligible Subjects : adults (minimum age> 20 years; maximum age ≦ 70 years old) patients with thoracic surgery and over48 hours of continuous air leak. The exclusion criteria include: penicillin allergy,primary pneumothorax, esophageal cancer, immune dysfunction, those who can not sign a consent form, and pregnant or lactating, other serious concomitant illness such as uremia or liver cirrhosis. Study steps: eligible Patients will randomize according to computer-generated random numbers, with 1:1 ratio in sequentially numbered, sealed envelopes by a study nurse who was masked to the study. Randomization envelopes were opened, and randomization was performed by the study nurse after informed consent was obtain. Eligible inpatients were randomized to the OK-432 group or the normal saline (NS) group，each group are 40 cases.
All subjects were observed by the physician who was masked to the study， about air leak stop time, chest tube removal time, discharge time, outpatient chest X-ray, pulmonary function tests as necessary. cases if persistent air leak more than seven days, the attending physician determines whether pleurodesis again or surgery or other medical treatment. Finally, the researcher who do not know groups will collection data by "air leak case record form" including diagnosis, surgical site，the start and end time of the surgery, the use of antibiotics, discomfort problems (pain , stomach discomfort, cough, fever> 38 ℃, allergic reactions and respiratory discomfort), postoperative air leak time, air leak stop time , chest tube removal time, discharge time, the data will be use SPSS20.0 version of the statistical software package, and T-test, pair T-test ，Anova ,linear correlation statistical methods for analysis.
Outcome measures: OK-432 success rate, OK-432 side effects, air leak time, chest tube remove time, length of hospital stay.
Detailed description
[Background and Objective] :Air leak produced after thoracic surgery is a common phenomenon.Prolonged chest tube placement can lead to empyema or infection, and extended hospitalization or even death. In 2010 many researchers reported that The incidence of lung resection produce air leak about 8-26% (Singhal et al., 2010), and even up to 50% (Mueller \& Marzluf, 2014).How to effectively treatment is still not clear.The chemical pleurodesis is an effective option in management of air leak.There are several chemical agents for pleurodesis, such as tetracycline and minocycline, talc, Taurolidine, bleomycin, iodopovidone, picibanil (OK-432), silver nitrate, quinacrine. What kind of chemical agent effective remain controversial. A study evaluated after thoracoscopic operation for primary spontaneous pneumothorax the safety and efficacy of chemical pleurodesis with a comparison between minocycline and OK-432. The OK-432 pleurodesis (19 patients) as the primary treatment and the primary success rate was 95%.(How et al., 2014).Another retrospective case-control study examining post-isolated lobectomies and bilobectomies by thoracotomy of Persistent air leak，sclerosis (talc, bleomycin, minocycline, doxycycline)for the treatment of prolonged air leak was successful in 40 of 41 patients (the success rate of 97.6%) (Liberman et al., 2010). The prolonged air leaks after major pulmonary resection still no empirical treatment of clinical research.
Hypothesis: patients were persistent air leak after 48 hours chest surgery will perform OK-432 pleurodesis .The chest tube time can reduce and length of hospital stay. Extended applications can significantly reduce medical costs and manpower, and to explore OK -432 pleurodesis side effects and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OK-432 pleurodesis | Experimental | Drug: OK-432 pleurodesisPicibanil ( OK-432 ) ,OK-432 (KE Z Klinische Einbeit; 1 KE contains 0.1 mg of dried cocci; UKIMA PLANT OF CHUGAI PHARMA MANUFACTURING CO, LTD; JAPAN). |
| normal saline pleurodesis | Active comparator | Drug: normal saline pleurodesis(Normal Saline),Isotonic Sodium Chloride Solution |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were eligible for this study if they were more than 20 and less than 70 years old of age and under thoracic surgery that air leak lasting more than 48 hours form chest drainage bottles.
Key exclusion criteria (1 listed)
- penicillin allergy, primary pneumothorax, esophageal cancer, immune dysfunction, those who can not sign a consent form, and pregnant or lactating, other serious concomitant illness such as uremia or liver cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OK-432 pleurodesisAlso: Picibanil1.Pain medications (if no contraindications) Before half hour; Bain (IM ,0.15mg / kg). 2. Make the patient supine position 3. Near the body of patient's chest tube is the injection site disinfection with the alcoholic Betadine and alcohol repeated three times.4. 20 cc of 2% lidocaine hydrochloride (400 mg) was instilled into the pleural cavity through the chest tube 5. A solution of 30 cc of normal saline containing 5 KE of OK-432 (KE Z Klinische Einbeit; 1 KE contains 0.1 mg of dried cocci).6. Inject air 20 cc 7. The injection site will cover with op site and the rubber tube that connecting the chest tube and chest bottle was raised 40-60 cm above the patient to trap the sclerosing agent but allow air to pass 8. Patients will reposition (left and right side)every 30 minutes in 2 hours | Drug | OK-432 pleurodesis |
| normal saline pleurodesisAlso: normal salineMake the patient supine position , Near the body of patient's chest tube is the injection site disinfection with the alcoholic Betadine and alcohol repeated three times.injected a solution of 30 cc of normal saline , and then injected into 20 cc air to the rubber chest tube , so that normal saline can completely into the chest, the injection site will cover with op site, use a rubber band to the rubber chest tube for hanging from the patient's body 40-60 cm high.Patients will reposition (left and right side)every 30 minutes in 2 hours | Drug | normal saline pleurodesis |
Primary outcome
OK-432 success rate
Time frame: 48 hours
The success rate of OK-432 was defined chest bottle no bubbles appear when coughing, then CXR was perform the next day after pleurodesis, and after cessation of the air leak,the chest tube is remove .
1 secondary outcome
OK-432 side effects
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Shing Chen study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OK-432 pleurodesis and normal saline pleurodesis in people with Postoperative Air Leak, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Yin Hsieh (886-2-23123456 ext. 63407, peiyin3111@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OK-432 success rate (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.