Tubeless Intersegmentectomy Plane Identification With Fluorography

The Second Hospital of Shandong University

Status: Enrolling

Conditions: Postoperative Complications; Operation Time

Treatments: Procedure: inflation- deflation line combined with ICG fluorography

Study type: Interventional

Funder types: Other

Identifiers

NCT05479825

Tubeless Intersegmental ICG

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. cardio- pulmonary function can tolerate the minimally invasive surgery (including VATS and robotic surgery);
2. benign pulmonary lesion considering for segmentectomy;
3. ≤2cm pulmonary adenocarcinoma with ground- glass components, considering for segmentectomy.

Exclusion criteria

1. cardio- pulmonary function can not tolerate the minimally invasive surgery (including VATS and robotic surgery);
2. segmentectomy is not considered as the surgery plan.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

inflation- deflation line combined with ICG fluorography

Experimental group

Description:

Identification of the intersegmental plane using inflation- deflation line combined with ICG fluorography under the status of tubeless

Treatment:

Procedure: inflation- deflation line combined with ICG fluorography