Operation TimeNCT05479825
Tubeless Intersegmentectomy Plane Identification With Fluorography
A study testing inflation- deflation line combined with ICG fluorography in people with Operation Time and Postoperative Complications, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
Background: We aimed to evaluate the combination of inflation- deflation method and fluorography with the ICG injection in the tubeless minimally invasive segmentectomy (no intubation, VATS or Robotic). Methods: A one- armed, prospective randomized controlled study was designed. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Operation Time, Postoperative Complications
- What is being tested?
- inflation- deflation line combined with ICG fluorography
- 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 Jan 2022to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cardio- pulmonary function can tolerate the minimally invasive surgery (including VATS and robotic surgery);
- benign pulmonary lesion considering for segmentectomy;
- ≤2cm pulmonary adenocarcinoma with ground- glass components, considering for segmentectomy.
Who cannot join
- cardio- pulmonary function can not tolerate the minimally invasive surgery (including VATS and robotic surgery);
- segmentectomy is not considered as the surgery plan.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yunpeng Zhao
Jinan, Other (Non U.s.), 250033
Yunpeng Zhao, doctor, 18766188692, zyp_baggio@163.com
About this study
Official title: Tubeless Intersegmentectomy Plane Identification With Inflation- Deflation Line Combined With Fluorography
Background: We aimed to evaluate the combination of inflation- deflation method and fluorography with the ICG injection in the tubeless minimally invasive segmentectomy (no intubation, VATS or Robotic).
Methods: A one- armed, prospective randomized controlled study was designed. The intersegmental plane was not so clear during the tubeless minimally invasive segmentectomy, and the presentation of the plane sometimes cost more time. This study will evaluate consecutive patients with the combination of inflation- deflation method and fluorography with the ICG injection.
- Conditions
- Operation Time, Postoperative Complications
- Being tested
- inflation- deflation line combined with ICG fluorography
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflation- deflation line combined with ICG fluorographyProcedure or surgery
Identification of the intersegmental plane using inflation- deflation line combined with ICG fluorography under the status of tubeless
| Study group | Role | What they receive |
|---|---|---|
| inflation- deflation line combined with ICG fluorography | Experimental | Identification of the intersegmental plane using inflation- deflation line combined with ICG fluorography under the status of tubeless Receives: Procedure: inflation- deflation line combined with ICG fluorography |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of description and management of the intersegmental plane
time of description and management of the intersegmental plane
Measured: during surgery
perioperative complication rate
perioperative complication rate
Measured: within 7 days after surgery
incisal margin of the tumor
incisal margin of the tumor
Measured: during surgery
Secondary outcomes (1)
disease- free survival
DFS
Measured: within 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operation TimeStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaogang Zhao, doctor, Study director, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479825
- Sponsor's protocol ID
- Tubeless Intersegmental ICG
- Status last verified
- May 2022
- First submitted
- 27 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tubeless Intersegmentectomy Plane Identification With Inflation- Deflation Line Combined With Fluorography
- ClinicalTrials.gov ID
- NCT05479825
- Acronym / sponsor ID
- Tubeless Intersegmental ICG
- Conditions
- Operation Time, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Jul 2022 (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.
Background: We aimed to evaluate the combination of inflation- deflation method and fluorography with the ICG injection in the tubeless minimally invasive segmentectomy (no intubation, VATS or Robotic).
Methods: A one- armed, prospective randomized controlled study was designed. The intersegmental plane was not so clear during the tubeless minimally invasive segmentectomy, and the presentation of the plane sometimes cost more time. This study will evaluate consecutive patients with the combination of inflation- deflation method and fluorography with the ICG injection.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inflation- deflation line combined with ICG fluorography | Experimental | Procedure: inflation- deflation line combined with ICG fluorographyIdentification of the intersegmental plane using inflation- deflation line combined with ICG fluorography under the status of tubeless |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cardio- pulmonary function can tolerate the minimally invasive surgery (including VATS and robotic surgery);
- benign pulmonary lesion considering for segmentectomy;
- ≤2cm pulmonary adenocarcinoma with ground- glass components, considering for segmentectomy.
Key exclusion criteria (2 listed)
- cardio- pulmonary function can not tolerate the minimally invasive surgery (including VATS and robotic surgery);
- segmentectomy is not considered as the surgery plan.
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 |
|---|---|---|
| inflation- deflation line combined with ICG fluorographyIdentification of the intersegmental plane using inflation- deflation line combined with ICG fluorography under the status of tubeless | Procedure or surgery | inflation- deflation line combined with ICG fluorography |
Primary outcome
time of description and management of the intersegmental plane
Time frame: during surgery
time of description and management of the intersegmental plane
perioperative complication rate
Time frame: within 7 days after surgery
perioperative complication rate
incisal margin of the tumor
Time frame: during surgery
incisal margin of the tumor
1 secondary outcome
disease- free survival
Time frame: within 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
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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.
Xiaogang Zhao, doctor study director
The Second Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inflation- deflation line combined with ICG fluorography in people with Operation Time and Postoperative Complications, run by The Second Hospital of Shandong 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 29 Jul 2022. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunpeng Zhao, doctor (18766188692, zyp_baggio@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of description and management of the intersegmental plane (time frame: during surgery). The study lists 3 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 Jul 2022.