Tubeless Intersegmentectomy Plane Identification With Fluorography

NCT ID: NCT05479825

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2028-12-31

Brief Summary

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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

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Conditions

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Operation Time Postoperative Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

inflation- deflation line combined with ICG fluorography

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaogang Zhao, doctor

Role: STUDY_DIRECTOR

The Second Hospital of Shandong University

Locations

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Yunpeng Zhao

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunpeng Zhao, doctor

Role: CONTACT

Phone: 18766188692

Email: [email protected]

Facility Contacts

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Yunpeng Zhao, doctor

Role: primary

Other Identifiers

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Tubeless Intersegmental ICG

Identifier Type: -

Identifier Source: org_study_id