Mediastinal NodesNCT03743389
Application Study of 12G Pigtail Catheter Used for Post-operative Drainage After Thoracoscopic Surgery for Mediastinal Nodes
A study testing 12G pigtail catheter and 16F chest tube in people with Mediastinal Nodes, run by Tongji Hospital.
Trial summary
Pigtail catheter(PC) has been used for thoracic drainage in the patients with pneumothorax or traumatic hemothorax/hemopneumothorax, and some study indicated that PC could obtain similar outcomes when comparing with chest tube(CT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mediastinal Nodes
- What is being tested?
- 12G pigtail catheter and 16F chest tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2018to 30 Nov 2019
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 80 years of age.
- Diagnosed with potentially resectable mediastinal mass.
- With indication for uniportal-VATS.
- For whom informed consent will be obtained before the study.
Who cannot join
- Previous thoracic surgery at the same side.
- Have to receive open surgery although uniportal-VATS is planned.
- Pregnancy.
- Refuse to sigh the consent
About this study
Pigtail catheter(PC) has been used for thoracic drainage in the patients with pneumothorax or traumatic hemothorax/hemopneumothorax, and some study indicated that PC could obtain similar outcomes when comparing with chest tube(CT). Although PC could drain air and fluid out from pleural cavity and also help pulmonary re-expanding, rare reports are available to thoracic post-operative management. Uniportal video-assisted thoracoscopic surgery(VATS) has been widely applied in many medical center in recent years, most of mediastinal nodes could be resected under uniportal-VATS. This study aims to further study the application of 12G PC during post-operative management and comparing the validity and safety between PC(12G) and CT(16F) after uniportal-VATS for mediastinal nodes resection.
- Conditions
- Mediastinal Nodes
- Being tested
- 12G pigtail catheter, 16F chest tube
- Keywords
- uniportal video-assisted thoracoscopic surgery, mediastinal nodes, chest drainage, pigtail catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12G pigtail catheterDevice
12G pigtail catheter would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with the traditional 16F chest tube.
16F chest tubeDevice
16F chest tube would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with 12G pigtail catheter.
| Study group | Role | What they receive |
|---|---|---|
| 12G pigtail catheter | Experimental | Not described Receives: Device: 12G pigtail catheter |
| 16F chest tube | Active comparator | Not described Receives: Device: 16F chest tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
total drainage volume
Measured: 1 month
tube duration
Measured: 1 month
Secondary outcomes (6)
post-operative pain
assessed via the "Visual Analogue Scale" (VAS) which ranging from 0 (no pain) to 10 (worst imaginable pain).
Measured: 3 days after operation
rate of subcutaneous emphysema
Measured: 1 month
infection rate of incision
Measured: 1 month
length of hospital stay after surgery
Measured: 1 month
rate of chest tube re-insertion or thoracocentesis
Measured: 1 month
satisfaction of the incision after healing
Patients would be asked if they are satified with the appearence of the healed incision at the one-month follow-up evalution.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal NodesStudies of the same condition, open and under way.
- More trials run by Tongji 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743389
- Sponsor's protocol ID
- TJTS-CT001
- Status last verified
- Sep 2018
- First submitted
- 27 Sep 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Study of 12G Pigtail Catheter Used for Post-operative Drainage After Thoracoscopic Surgery for Mediastinal Nodes
- ClinicalTrials.gov ID
- NCT03743389
- Acronym / sponsor ID
- TJTS-CT001
- Conditions
- Mediastinal Nodes
- Keywords
- uniportal video-assisted thoracoscopic surgery, mediastinal nodes, chest drainage, pigtail catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 16 Nov 2018 (actual)
- 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.
Pigtail catheter(PC) has been used for thoracic drainage in the patients with pneumothorax or traumatic hemothorax/hemopneumothorax, and some study indicated that PC could obtain similar outcomes when comparing with chest tube(CT). Although PC could drain air and fluid out from pleural cavity and also help pulmonary re-expanding, rare reports are available to thoracic post-operative management. Uniportal video-assisted thoracoscopic surgery(VATS) has been widely applied in many medical center in recent years, most of mediastinal nodes could be resected under uniportal-VATS. This study aims to further study the application of 12G PC during post-operative management and comparing the validity and safety between PC(12G) and CT(16F) after uniportal-VATS for mediastinal nodes resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12G pigtail catheter | Experimental | Device: 12G pigtail catheter |
| 16F chest tube | Active comparator | Device: 16F chest tube |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18 and 80 years of age.
- Diagnosed with potentially resectable mediastinal mass.
- With indication for uniportal-VATS.
- For whom informed consent will be obtained before the study.
Key exclusion criteria (4 listed)
- Previous thoracic surgery at the same side.
- Have to receive open surgery although uniportal-VATS is planned.
- Pregnancy.
- Refuse to sigh the consent
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 |
|---|---|---|
| 12G pigtail catheter12G pigtail catheter would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with the traditional 16F chest tube. | Device | 12G pigtail catheter |
| 16F chest tube16F chest tube would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with 12G pigtail catheter. | Device | 16F chest tube |
Primary outcome
total drainage volume
Time frame: 1 month
tube duration
Time frame: 1 month
6 secondary outcomes
post-operative pain
Time frame: 3 days after operation
rate of subcutaneous emphysema
Time frame: 1 month
infection rate of incision
Time frame: 1 month
length of hospital stay after surgery
Time frame: 1 month
rate of chest tube re-insertion or thoracocentesis
Time frame: 1 month
satisfaction of the incision after healing
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 12G pigtail catheter and 16F chest tube in people with Mediastinal Nodes, run by Tongji Hospital.
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 4 inclusion and 4 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 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total drainage volume (time frame: 1 month). The study lists 2 primary outcomes in all. 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 16 Nov 2018.