Tubeless Intersegmentectomy Plane Identification With Fluorography

July 28, 2022 updated by: The Second Hospital of Shandong University

Tubeless Intersegmentectomy Plane Identification With Inflation- Deflation Line Combined 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Other (Non U.s.)
      • Jinan, Other (Non U.s.), China, 250033
        • Recruiting
        • Yunpeng Zhao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of description and management of the intersegmental plane
Time Frame: during surgery
time of description and management of the intersegmental plane
during surgery
perioperative complication rate
Time Frame: within 7 days after surgery
perioperative complication rate
within 7 days after surgery
incisal margin of the tumor
Time Frame: during surgery
incisal margin of the tumor
during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease- free survival
Time Frame: within 5 years after surgery
DFS
within 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2026

Study Completion (ANTICIPATED)

December 31, 2028

Study Registration Dates

First Submitted

July 27, 2022

First Submitted That Met QC Criteria

July 28, 2022

First Posted (ACTUAL)

July 29, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tubeless Intersegmental ICG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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