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Recruiting NCT05479825

Tubeless Intersegmentectomy Plane Identification With Fluorography

No phase Interventional Operation Time Postoperative Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: inflation- deflation line combined with ICG fluorography.
Who it may be relevant to
Registry conditions: Operation Time, Postoperative Complications. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Tubeless Intersegmentectomy Plane Identification With Inflation- Deflation Line Combined With Fluorography

Overview

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.

Interventions

  • Procedure 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

Primary outcome measures

  • time of description and management of the intersegmental plane [Time frame: during surgery]
  • perioperative complication rate [Time frame: within 7 days after surgery]
  • incisal margin of the tumor [Time frame: during surgery]
Secondary outcome measures (1)
  • disease- free survival [Time frame: within 5 years after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Yunpeng Zhao — Jinan

Identifiers

NCT: NCT05479825 · Tubeless Intersegmental ICG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗