NCT05478460

Brief Summary

The aim of this study is to evaluate whether preoperative CT- guided hookwire localization would influence the incidence and intensity of acute and chronic pain after VATS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

May 30, 2022

Last Update Submit

October 21, 2022

Conditions

Lung Cancer

Keywords

Lung cancerVideo-assisted Thoracoscopic Surgeryhookwire location

Outcome Measures

Primary Outcomes (2)

  • postoperative incidence and intensity of chronic pain after surgery

    the incidence and severity（11-point numerical rating scale,0=painless, 10=woest pain）of pain was assessed after VATS operation

    at postoperative 3rd month

  • postoperative incidence and intensity of chronic pain after surgery

    the incidence and severity（11-point numerical rating scale, 0=painless, 10=worst pain）of pain was assessed after VATS operation

    at postoperative 6th month

Secondary Outcomes (3)

  • postoperative length of stay in hospital

    an average of 1 week

  • satisfactory score

    from the day discharge from hospital to postoperative 6th month

  • intensity of postoperative acute pain

    from immediately after surgery(at postanesthesia care unit ) to postoperative 2nd day

Study Arms (2)

Group A

Before operation,patients were performed CT -guided hook wire localization(20G×120mm, PAJUNK medizintechnologie, Geisingen in Germany). patients were placed on a CT table in a suitable position(supine, prone, lateral) to obtain the shortest needle insertion route for their initial CT scan. Local anesthesia of the skin and planned puncture tract was performed using 10ml Lidocaine 1%. Next, the needle was inserted into or near the pulmonary nodule.

Other: Hookwire localization

Group B

without hookwire localization

Interventions

Hookwire localizationOTHER

Patients were performed CT -guided hook wire localization(20G×120mm, PAJUNK medizintechnologie, Geisingen in Germany). patients were placed on a CT table in a suitable position(supine, prone, lateral) to obtain the shortest needle insertion route for their initial CT scan. Local anesthesia of the skin and planned puncture tract was performed using 10ml Lidocaine 1%. Next, the needle was inserted into or near the pulmonary nodule.

Group A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The institutional review board approved this prospective study. This study included 138 consecutive patients who underwent CT-guided localization before VATS , of which 69 using hookwire (Group A) and 69 without hookwire (Group B). The inclusion criteria were as follows: patients were planned to underwent VATS for lung cancer .

You may qualify if:

  • Aged 18-75
  • patients who underwent underwent CT-guided localization before VATS
  • ASA I-II
  • BMI 18.5-30
  • no serious complications after localization
  • sign informed consent

You may not qualify if:

  • could not complish underwent CT-guided localization
  • selfexpression or visual dysfunction
  • having emergency surgery
  • a severe psychiatric illness
  • having chronic pain problems in the chest area
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

270 Dongan Road, Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jun Zhang, PhD

    Department of Anesthesiology, Fudan University Shanghai Cancer Center;

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chairman of Department of Anesthesiology

Study Record Dates

First Submitted

May 30, 2022

First Posted

July 28, 2022

Study Start

August 10, 2021

Primary Completion

July 21, 2022

Study Completion

July 21, 2022

Last Updated

October 24, 2022

Record last verified: 2022-10

Locations

CN(1)