Tubeless Intersegmentectomy Plane Identification With Fluorography

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05479825
• Other study ID #: Tubeless Intersegmental ICG
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: May 2022
• Source: The Second Hospital of Shandong University
• Contact: Yunpeng Zhao, doctor
• Phone: 18766188692
• Email: zyp_baggio[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Operation Time
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
China	Yunpeng Zhao	Jinan	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time of description and management of the intersegmental plane	time of description and management of the intersegmental plane	during surgery
Primary	perioperative complication rate	perioperative complication rate	within 7 days after surgery
Primary	incisal margin of the tumor	incisal margin of the tumor	during surgery
Secondary	disease- free survival	DFS	within 5 years after surgery