Tubeless Intersegmentectomy Plane Identification With Fluorography
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Second Hospital of Shandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
cardio- pulmonary function can not tolerate the minimally invasive surgery (including VATS and robotic surgery);
segmentectomy is not considered as the surgery plan.
Trial design
Design model
Single group
Treatments tested in this trial
inflation- deflation line combined with ICG fluorography
Procedure/SurgeryIdentification of the intersegmental plane using inflation- deflation line combined with ICG fluorography under the status of tubeless
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: inflation- deflation line combined with ICG fluorographyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
time of description and management of the intersegmental plane
time of description and management of the intersegmental plane
Time frame
during surgery2
perioperative complication rate
perioperative complication rate
Time frame
within 7 days after surgery3
incisal margin of the tumor
incisal margin of the tumor
Time frame
during surgerySecondary outcomes
1
disease- free survival
DFS
Time frame
within 5 years after surgerySponsors and contacts
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Source ClinicalTrials.gov