Back to resultsTubeless Intersegmentectomy Plane Identification With Fluorography
Primary Purpose
Operation Time, Postoperative Complications
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
inflation- deflation line combined with ICG fluorography
Sponsored by
About this trial
This is an interventional other trial for Operation Time
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- cardio- pulmonary function can not tolerate the minimally invasive surgery (including VATS and robotic surgery);
- segmentectomy is not considered as the surgery plan.
Sites / Locations
- Yunpeng ZhaoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
inflation- deflation line combined with ICG fluorography
Arm Description
Identification of the intersegmental plane using inflation- deflation line combined with ICG fluorography under the status of tubeless
Outcomes
Primary Outcome Measures
time of description and management of the intersegmental plane
time of description and management of the intersegmental plane
perioperative complication rate
perioperative complication rate
incisal margin of the tumor
incisal margin of the tumor
Secondary Outcome Measures
disease- free survival
DFS
Full Information
NCT ID
NCT05479825
First Posted
July 27, 2022
Last Updated
July 28, 2022
Sponsor
The Second Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT05479825
Brief Title
Tubeless Intersegmentectomy Plane Identification With Fluorography
Official Title
Tubeless Intersegmentectomy Plane Identification With Inflation- Deflation Line Combined With Fluorography
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Operation Time, Postoperative Complications
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
inflation- deflation line combined with ICG fluorography
Arm Type
Experimental
Arm Description
Identification of the intersegmental plane using inflation- deflation line combined with ICG fluorography under the status of tubeless
Intervention Type
Procedure
Intervention Name(s)
inflation- deflation line combined with ICG fluorography
Intervention Description
Identification of the intersegmental plane using inflation- deflation line combined with ICG fluorography under the status of tubeless
Primary Outcome Measure Information:
Title
time of description and management of the intersegmental plane
Description
time of description and management of the intersegmental plane
Time Frame
during surgery
Title
perioperative complication rate
Description
perioperative complication rate
Time Frame
within 7 days after surgery
Title
incisal margin of the tumor
Description
incisal margin of the tumor
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
disease- free survival
Description
DFS
Time Frame
within 5 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
cardio- pulmonary function can not tolerate the minimally invasive surgery (including VATS and robotic surgery);
segmentectomy is not considered as the surgery plan.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunpeng Zhao, doctor
Phone
18766188692
Email
zyp_baggio@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaogang Zhao, doctor
Organizational Affiliation
The Second Hospital of Shandong University
Official's Role
Study Director
Facility Information:
Facility Name
Yunpeng Zhao
City
Jinan
State/Province
Other (Non U.s.)
ZIP/Postal Code
250033
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunpeng Zhao, doctor
Phone
18766188692
Email
zyp_baggio@163.com
12. IPD Sharing Statement
Learn more about this trial
Tubeless Intersegmentectomy Plane Identification With Fluorography
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