Tubeless Intersegmentectomy Plane Identification With Fluorography

NCT05479825 | Recruiting DMC

• 1 other identifier: Tubeless Intersegmental ICG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Operation Time; Postoperative Complications

Outcome Measures

Primary Outcomes (3)

• time of description and management of the intersegmental plane

  time of description and management of the intersegmental plane

  during surgery

• perioperative complication rate

  perioperative complication rate

  within 7 days after surgery

• incisal margin of the tumor

  incisal margin of the tumor

  during surgery

Secondary Outcomes (1)

• disease- free survival

  within 5 years after surgery

Study Arms (1)

inflation- deflation line combined with ICG fluorography

EXPERIMENTAL

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

Procedure: inflation- deflation line combined with ICG fluorography

Interventions

inflation- deflation line combined with ICG fluorography PROCEDURE

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

inflation- deflation line combined with ICG fluorography

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

Yunpeng Zhao

Jinan, Other (Non U.s.), 250033, China

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaogang Zhao, doctor

  The Second Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Yunpeng Zhao, doctor

CONTACT

18766188692; zyp_baggio@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 29, 2022

Record last verified: 2022-05

Locations

CN (1)