SurgeryNCT06015399
Methods of Establishing Intersegmental Plane in Segmentectomy
A study testing Implementation of closed insufflation technique during segmentectomy and Implementation of dilatation and collapse technique during segmentectomy in people with Surgery, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The aim of this study is to perform a prospective, single-center, randomized controlled study to explore whether closed insufflation technique is not inferior to dilatation and collapse technique in segmentectomy, and to provide a new option for establishing intersegmental plane in segmentectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Surgery
- What is being tested?
- Implementation of closed insufflation technique during segmentectomy and Implementation of dilatation and collapse technique during segmentectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Sep 2023to Mar 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily join and sign a written informed consent;
- The age of the subjects is 18-75 years old, regardless of gender;
- The ECOG PS was 0 or 1;
- Three-dimensional visualization was performed before surgery, and the surgeon judged that the tumor could be completely removed by segmentectomy, and surgical margin was expected to be greater than 2cm or the maximum diameter of the nodule;
- Thin-slice CT suggests any of the following: ① The diameter of pulmonary nodules is 2-3cm and the consolidation-tumor ratio (CTR) is less than 0.25; ② Pulmonary nodule diameter ≤2cm and 0.25 < CTR < 0.5; ③ Non-peripheral pulmonary nodule diameter ≤2cm and CTR≤0.25;
- cN0 and no distant metastasis;
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- Intraoperative freezing examination or postoperative paraffin examination suggest early lung adenocarcinoma;
- Intraoperative freezing disease of station 12 lymph nodes showed no cancer metastasis;
- Preoperative anesthesia risk assessment: American Society of Anesthesiologists (ASA) Level I-III;
- Has no history of lung resection;
- Has not received anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy and immunotherapy.
Who cannot join
- The subject did not understand the study protocol, did not cooperate or refused to sign the informed consent;
- The subject has a history of malignant tumor or has previously received anti-tumor therapy;
- 3D visualization was not received before surgery;
- The surgeon judged that segmentectomy could not ensure complete resection of the tumor;
- has a history of lung resection, or chest trauma or surgery on the affected side of chest cavity;
- Extensive intraoperative dense thoracic adhesion;
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- Conversion to thoracotomy;
- Intraoperative frozen examination of intrapulmonary lymph nodes indicated cancer metastasis;
- Pulmonary nodules are located in the right middle lung;
- Suffered from chronic bronchitis, emphysema, asthma and other chronic lung diseases;
- Other conditions unsuitable for inclusion in this study deemed by the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Thoracic Surgery, Second Xiangya Hospital of Central South University, China
Changsha, Hunan, 410011
About this study
Official title: Methods of Establishing Intersegmental Plane in Segmentectomy: a Prospective Randomized Controlled Study
The aim of this study is to perform a prospective, single-center, randomized controlled study to explore whether closed insufflation technique is not inferior to dilatation and collapse technique in segmentectomy, and to provide a new option for establishing intersegmental plane in segmentectomy.
Read the detailed description
This is a single-center, prospective, randomized controlled study. A total of 200 subjects undergoing segmentectomy are scheduled to be enrolled within 1 year, and the subjects are randomly divided into closed insufflation group or dilatation and collapse group using a random number table generated by the computer, with 100 cases in each group. Intersegmental plane resolution grading, perioperative complications, operative time, intraoperative blood loss, postoperative hospitay stay, and pulmonary function 3 months and 1 year after surgery will be extracted and compared between the groups.
- Conditions
- Surgery
- Being tested
- Implementation of closed insufflation technique during segmentectomy, Implementation of dilatation and collapse technique during segmentectomy
- Keywords
- segmentectomy, intersegmental plane, closed insufflation technique, dilatation and collapse technique, randomized controlled study
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of closed insufflation technique during segmentectomyProcedure or surgery
After the identification the targeted segmental bronchus during the operation,ligating the proximal end of the targeted bronchus. Put the vessel separation forceps in the distal bronchial space to avoid the accidental damage of the vessels. Use a 50ml syringe to inject air into the distal bronchus (about 100ml is expected) until the intersegmental plane is satisfactory. Divide the target bronchus using the cutting and closing device.
Implementation of dilatation and collapse technique during segmentectomyProcedure or surgery
Divide the target bronchus using the cutting and closing device. Ask the anesthesiologist to inflate the lung completely from pure oxygen to the affected side and then change to single lung ventilation. Wait for the intersegmental plane to appear(usually about 15 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Closed insufflation technique group | Experimental | Closed insufflation technique is characterized by ligation in the proximal portion of targeted bronchus and gas injection in the distal portion. Closed insufflation technique group includes patients undergoing segmentectomy using closed insufflation technique. Receives: Procedure: Implementation of closed insufflation technique during segmentectomy |
| Dilatation and collapse technique | Active comparator | Dilatation and collapse technique is characterized by pure oxygen dilatation and subsequent collapse after the division of targeted bronchus. Dilatation and collapse technique group includes patients undergoing segmentectomy using Dilatation and collapse technique. Receives: Procedure: Implementation of dilatation and collapse technique during segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intersegmental plane clarity grading
Intersegmental plane clarity will be graded as followed: G1: partial collapse of targeted parenchymal tissue, G2: partial dilatation of non-targeted adjacent tissue, G3: dilatation of targeted tissue and unclearness of intersegmental plane, G4: entire dilatation of targeted tissue and clearness of intersegmental plane.
Measured: intraoperatively
Surgical complications
Surgical complications will be assessed according to the Society of Thoracic Surgeons database criteria.
Measured: Up to 3 months
Operative time required for segmentectomy
Operative time required for segmentectomy will be measured as the total minutes from initiation to completion of segmentectomy.
Measured: From the dissection of segmental structures to finish of segementectomy
Pulmonary function 3 months and 1 year after surgery
Pulmonary function includes ventilation and diffusion function. Pulmonary function will be measured at two time points including 3 months and 1 year after surgery.
Measured: Up to 1 year
Secondary outcomes (5)
Intraoperative blood loss
Intraoperative blood loss will be measured as the total volume of blood loss during the operation.
Measured: Intraoperatively
Postoperative hospital stay
Postoperative hospital stay will be measured as the number of days between surgery and discharge.
Measured: Up to 2 weeks
Days of chest tube placement
Days of chest tube placement will be measured as the number of days between surgery and chest tube pull-out.
Measured: Up to 2 weeks
Safety margin
Minimum distance between nodule and every margin can be measured preoperatively by 3D reconstruction tool and intraoperatively by ruler after the targetd segment has been resected.
Measured: Up to 1 week
Volume of targeted parenchymal tissue
Volume of targeted parenchymal tissue will be calculated by 3D reconstruction tool.
Measured: Up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Wenliang, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015399
- Sponsor's protocol ID
- LYF2023098
- Status last verified
- Aug 2023
- First submitted
- 20 Aug 2023
- Last updated
- 29 Aug 2023
- 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 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methods of Establishing Intersegmental Plane in Segmentectomy: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06015399
- Acronym / sponsor ID
- LYF2023098
- Conditions
- Surgery
- Keywords
- segmentectomy, intersegmental plane, closed insufflation technique, dilatation and collapse technique, randomized controlled study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 29 Aug 2023 (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.
The aim of this study is to perform a prospective, single-center, randomized controlled study to explore whether closed insufflation technique is not inferior to dilatation and collapse technique in segmentectomy, and to provide a new option for establishing intersegmental plane in segmentectomy.
Detailed description
This is a single-center, prospective, randomized controlled study. A total of 200 subjects undergoing segmentectomy are scheduled to be enrolled within 1 year, and the subjects are randomly divided into closed insufflation group or dilatation and collapse group using a random number table generated by the computer, with 100 cases in each group. Intersegmental plane resolution grading, perioperative complications, operative time, intraoperative blood loss, postoperative hospitay stay, and pulmonary function 3 months and 1 year after surgery will be extracted and compared between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed insufflation technique group | Experimental | Procedure: Implementation of closed insufflation technique during segmentectomyClosed insufflation technique is characterized by ligation in the proximal portion of targeted bronchus and gas injection in the distal portion. Closed insufflation technique group includes patients undergoing segmentectomy using closed insufflation technique. |
| Dilatation and collapse technique | Active comparator | Procedure: Implementation of dilatation and collapse technique during segmentectomyDilatation and collapse technique is characterized by pure oxygen dilatation and subsequent collapse after the division of targeted bronchus. Dilatation and collapse technique group includes patients undergoing segmentectomy using Dilatation and collapse technique. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients voluntarily join and sign a written informed consent;
- The age of the subjects is 18-75 years old, regardless of gender;
- The ECOG PS was 0 or 1;
- Three-dimensional visualization was performed before surgery, and the surgeon judged that the tumor could be completely removed by segmentectomy, and surgical margin was expected to be greater than 2cm or the maximum diameter of the nodule;
- Thin-slice CT suggests any of the following: ① The diameter of pulmonary nodules is 2-3cm and the consolidation-tumor ratio (CTR) is less than 0.25; ② Pulmonary nodule diameter ≤2cm and 0.25 < CTR < 0.5; ③ Non-peripheral pulmonary nodule diameter ≤2cm and CTR≤0.25;
Key exclusion criteria (11 listed)
- The subject did not understand the study protocol, did not cooperate or refused to sign the informed consent;
- The subject has a history of malignant tumor or has previously received anti-tumor therapy;
- 3D visualization was not received before surgery;
- The surgeon judged that segmentectomy could not ensure complete resection of the tumor;
- has a history of lung resection, or chest trauma or surgery on the affected side of chest cavity;
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 |
|---|---|---|
| Implementation of closed insufflation technique during segmentectomyAfter the identification the targeted segmental bronchus during the operation,ligating the proximal end of the targeted bronchus. Put the vessel separation forceps in the distal bronchial space to avoid the accidental damage of the vessels. Use a 50ml syringe to inject air into the distal bronchus (about 100ml is expected) until the intersegmental plane is satisfactory. Divide the target bronchus using the cutting and closing device. | Procedure or surgery | Closed insufflation technique group |
| Implementation of dilatation and collapse technique during segmentectomyDivide the target bronchus using the cutting and closing device. Ask the anesthesiologist to inflate the lung completely from pure oxygen to the affected side and then change to single lung ventilation. Wait for the intersegmental plane to appear(usually about 15 minutes). | Procedure or surgery | Dilatation and collapse technique |
Primary outcome
Intersegmental plane clarity grading
Time frame: intraoperatively
Intersegmental plane clarity will be graded as followed: G1: partial collapse of targeted parenchymal tissue, G2: partial dilatation of non-targeted adjacent tissue, G3: dilatation of targeted tissue and unclearness of intersegmental plane, G4: entire dilatation of targeted tissue and clearness of intersegmental plane.
Surgical complications
Time frame: Up to 3 months
Surgical complications will be assessed according to the Society of Thoracic Surgeons database criteria.
Operative time required for segmentectomy
Time frame: From the dissection of segmental structures to finish of segementectomy
Operative time required for segmentectomy will be measured as the total minutes from initiation to completion of segmentectomy.
Pulmonary function 3 months and 1 year after surgery
Time frame: Up to 1 year
Pulmonary function includes ventilation and diffusion function. Pulmonary function will be measured at two time points including 3 months and 1 year after surgery.
5 secondary outcomes
Intraoperative blood loss
Time frame: Intraoperatively
Postoperative hospital stay
Time frame: Up to 2 weeks
Days of chest tube placement
Time frame: Up to 2 weeks
Safety margin
Time frame: Up to 1 week
Volume of targeted parenchymal tissue
Time frame: Up to 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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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 Implementation of closed insufflation technique during segmentectomy and Implementation of dilatation and collapse technique during segmentectomy in people with Surgery, run by Second Xiangya Hospital of Central South 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 11 inclusion and 11 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 29 Aug 2023. 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 Yan Hu, M.D., Ph.D. (+8685296122, yanhu@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intersegmental plane clarity grading (time frame: intraoperatively). The study lists 4 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 29 Aug 2023.