Lung NeoplasmsNCT04309955
Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery
A study testing pigtail catheter in people with Lung Neoplasms and Lung Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Lung cancer is the leading cause of cancer-related death worldwide. Thoracoscopic pulmonary resection is a prevalent management for early stage of lung cancer. Placement of traditional chest tube is the standard procedure after surgery, which causes pain that cannot be ignored. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Neoplasms, Lung Cancer, Pulmonary Neoplasm
- What is being tested?
- pigtail catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Apr 2020
- 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
- 18<age<80;
- Patients with lung cancer;
- Thoracoscopic lung resection;
- Single chest-tube insertion.
Who cannot join
- A history of preoperative chemotherapy or radiotherapy;
- Presence of distant tumor metastasis;
- Pneumonectomy;
- Dysfunction of cardiorespiratory system or other surgical contraindications.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Kun Li, MD, +8615023072303 ext. 023-68757983, soloonline1981@163.com
Jinghai Zhou, MD, +8613983612263 ext. 023-68757982, tmmuzjh@163.com
About this study
Official title: Randomized Clinical Trial of Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery for Lung Cancer
Lung cancer is the leading cause of cancer-related death worldwide. Thoracoscopic pulmonary resection is a prevalent management for early stage of lung cancer. Placement of traditional chest tube is the standard procedure after surgery, which causes pain that cannot be ignored. We aimed to determine whether a modified thoracic drainage strategy based on pigtail catheter associated with better clinical results compared with traditional methods after thoracoscopic surgery for lung cancer.
- Conditions
- Lung Neoplasms, Lung Cancer, Pulmonary Neoplasm, Postoperative Pain, Thoracoscopic Surgery
- Being tested
- pigtail catheter
- Keywords
- chest tube, pigtail catheters, chest tube drainage, thoracic drainage, Lung Cancer, thoracoscopic surgery, Pulmonary Neoplasm
- Medical subject headings
- Lung Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pigtail catheterProcedure or surgery
After inserting the chest tube, add a pigtail catheter into the posterior axillary lines of the 7th intercostal.
| Study group | Role | What they receive |
|---|---|---|
| modified thoracic drainage group | Experimental | After surgery, both a chest tube and a pigtail catheter are inserted into the middle and posterior axillary lines of the 7th intercostal space, respectively. Receives: Procedure: pigtail catheter |
| traditional thoracic drainage group | No intervention | After surgery, only a chest tube is inserted into the midaxillary line of the 7th intercostal space, traditionally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest tube drainage duration
The number of days from operation day to the day of chest tube removal
Measured: From date of operation until the date of chest tube removal, assessed up to 7 days
Volume of drainage
Total volume of thoracic drainage (ml)
Measured: From date of operation until the date of removal of the chest tube and pigtail catheter, assessed up to 7 days.
Secondary outcomes (1)
Postoperative hospital stay
The numbers of days of patients stay in the hospital after surgery
Measured: From date of operation until the date of hospital discharge, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Dec 2019
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Li, MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309955
- Sponsor's protocol ID
- Kli3
- Status last verified
- Mar 2020
- First submitted
- 8 Mar 2020
- Last updated
- 18 Mar 2020
- 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Modified Versus Traditional Thoracic Drainage After Thoracoscopic Surgery for Lung Cancer
- ClinicalTrials.gov ID
- NCT04309955
- Acronym / sponsor ID
- Kli3
- Conditions
- Lung Neoplasms, Lung Cancer, Pulmonary Neoplasm, Postoperative Pain, Thoracoscopic Surgery
- Keywords
- chest tube, pigtail catheters, chest tube drainage, thoracic drainage, Lung Cancer, thoracoscopic surgery, Pulmonary Neoplasm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 17 Mar 2020 (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.
Lung cancer is the leading cause of cancer-related death worldwide. Thoracoscopic pulmonary resection is a prevalent management for early stage of lung cancer. Placement of traditional chest tube is the standard procedure after surgery, which causes pain that cannot be ignored. We aimed to determine whether a modified thoracic drainage strategy based on pigtail catheter associated with better clinical results compared with traditional methods after thoracoscopic surgery for lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modified thoracic drainage group | Experimental | Procedure: pigtail catheterAfter surgery, both a chest tube and a pigtail catheter are inserted into the middle and posterior axillary lines of the 7th intercostal space, respectively. |
| traditional thoracic drainage group | No intervention | –After surgery, only a chest tube is inserted into the midaxillary line of the 7th intercostal space, traditionally. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18<age<80;
- Patients with lung cancer;
- Thoracoscopic lung resection;
- Single chest-tube insertion.
Key exclusion criteria (4 listed)
- A history of preoperative chemotherapy or radiotherapy;
- Presence of distant tumor metastasis;
- Pneumonectomy;
- Dysfunction of cardiorespiratory system or other surgical contraindications.
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 |
|---|---|---|
| pigtail catheterAfter inserting the chest tube, add a pigtail catheter into the posterior axillary lines of the 7th intercostal. | Procedure or surgery | modified thoracic drainage group |
Primary outcome
Chest tube drainage duration
Time frame: From date of operation until the date of chest tube removal, assessed up to 7 days
The number of days from operation day to the day of chest tube removal
Volume of drainage
Time frame: From date of operation until the date of removal of the chest tube and pigtail catheter, assessed up to 7 days.
Total volume of thoracic drainage (ml)
1 secondary outcome
Postoperative hospital stay
Time frame: From date of operation until the date of hospital discharge, assessed up to 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pigtail catheter in people with Lung Neoplasms and Lung Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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 18 Mar 2020. 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 China. 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 Li Kun, MD (15023072303, soloonline1981@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest tube drainage duration (time frame: From date of operation until the date of chest tube removal, assessed up to 7 days). 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 18 Mar 2020.