NCT04309955

Brief Summary

Lung cancer is the leading cause of cancer-related death worldwide. Thoracoscopic pulmonary resection is a prevalent management for early stage of lung cancer. Placement of traditional chest tube is the standard procedure after surgery, which causes pain that cannot be ignored. We aimed to determine whether a modified thoracic drainage strategy based on pigtail catheter associated with better clinical results compared with traditional methods after thoracoscopic surgery for lung cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 8, 2020

Last Update Submit

March 16, 2020

Conditions

Keywords

chest tubepigtail catheterschest tube drainagethoracic drainageLung Cancerthoracoscopic surgeryPulmonary Neoplasm

Outcome Measures

Primary Outcomes (2)

  • Chest tube drainage duration

    The number of days from operation day to the day of chest tube removal

    From date of operation until the date of chest tube removal, assessed up to 7 days

  • Volume of drainage

    Total volume of thoracic drainage (ml)

    From date of operation until the date of removal of the chest tube and pigtail catheter, assessed up to 7 days.

Secondary Outcomes (1)

  • Postoperative hospital stay

    From date of operation until the date of hospital discharge, assessed up to 30 days.

Other Outcomes (1)

  • Postoperative pain scores

    Postoperative day 1, 2, 3, 4 and 5.

Study Arms (2)

modified thoracic drainage group

EXPERIMENTAL

After surgery, both a chest tube and a pigtail catheter are inserted into the middle and posterior axillary lines of the 7th intercostal space, respectively.

Procedure: pigtail catheter

traditional thoracic drainage group

NO INTERVENTION

After surgery, only a chest tube is inserted into the midaxillary line of the 7th intercostal space, traditionally.

Interventions

After inserting the chest tube, add a pigtail catheter into the posterior axillary lines of the 7th intercostal.

modified thoracic drainage group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<age\<80;
  • Patients with lung cancer;
  • Thoracoscopic lung resection;
  • Single chest-tube insertion.

You may not qualify if:

  • A history of preoperative chemotherapy or radiotherapy;
  • Presence of distant tumor metastasis;
  • Pneumonectomy;
  • Dysfunction of cardiorespiratory system or other surgical contraindications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsPain, Postoperative

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kun Li, MD

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 17, 2020

Study Start

December 1, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

March 18, 2020

Record last verified: 2020-03

Locations