Tubeless Intersegmentectomy Plane Identification With Inflation- Deflation Line Combined With Fluorography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- perioperative complication rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
inflation- deflation line combined with ICG fluorography
Identification of the intersegmental plane using inflation- deflation line combined with ICG fluorography under the status of tubeless
Intervention: inflation- deflation line combined with ICG fluorography (Procedure)
Outcomes
Primary Outcomes
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
time of description and management of the intersegmental plane
Time Frame: during surgery
time of description and management of the intersegmental plane
Secondary Outcomes
- disease- free survival(within 5 years after surgery)