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NCT Number: NCT05479825

Tubeless Intersegmentectomy Plane Identification With Fluorography

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.

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Key information

Conditions

Operation Time Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yunpeng Zhao

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

Location status: Recruiting

Location contact

Yunpeng Zhao, doctor

CONTACT

[email protected]

18766188692

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. time of description and management of the intersegmental plane

    Time frame: during surgery

    time of description and management of the intersegmental plane

  2. perioperative complication rate

    Time frame: within 7 days after surgery

    perioperative complication rate

  3. incisal margin of the tumor

    Time frame: during surgery

    incisal margin of the tumor

Secondary outcomes

  1. disease- free survival

    Time frame: within 5 years after surgery

    DFS

Study contacts

Contact information is provided by the study sponsor or research team.

Yunpeng Zhao, doctor

CONTACT

[email protected]

18766188692

Sponsors and collaborators

Lead sponsor

The Second Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Jul 29, 2022
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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