Tubeless Intersegmentectomy Plane Identification With Fluorography

Not Applicable

Recruiting

• Conditions: Postoperative Complications; Operation Time
• Interventions: Procedure: inflation- deflation line combined with ICG fluorography

• Registration Number: NCT05479825
• Lead Sponsor: The Second Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-05
• Study First Submitted: 2022-07-27
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-07-29
• Last Update Posted: 2022-07-29
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
inflation- deflation line combined with ICG fluorography	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

Name	Time	Method
perioperative complication rate	within 7 days after surgery	perioperative complication rate
incisal margin of the tumor	during surgery	incisal margin of the tumor
time of description and management of the intersegmental plane	during surgery	time of description and management of the intersegmental plane

Secondary Outcome Measures

Name	Time	Method
disease- free survival	within 5 years after surgery	DFS

Trial Locations

Locations (1)

Yunpeng Zhao; 🇨🇳 Jinan, Other (Non U.s.), China