NCT03379350

Brief Summary

All patients undergo lateral thoracotomy or video-assisted thoracoscopic surgery (VATS) and are operated on by the same thoracic surgical team. All patients are managed with gravity drainage (water seal only, without suction) on the day of operation. Eligible patients are randomized to control group or clamping group at a 1:1 ratio before 3pm on the postoperative day. Patients in control group and those in clamping group are managed with different protocols after 3pm on the postoperative day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

3.8 years

First QC Date

September 30, 2017

Last Update Submit

July 18, 2021

Conditions

Management of Lung Cancer Patients

Keywords

lung cancersurgerychest tube clampingduration of chest tube drainagepostoperative stay

Outcome Measures

Primary Outcomes (1)

  • chest tube drainage duration

    time from operation day to the day of chest tube removal

    From date of operation until the date of chest tube removal, assessed up to 10 days

Secondary Outcomes (1)

  • postoperative hospital stay

    From date of operation until the date of hospital discharge, assessed up to 2 weeks

Other Outcomes (3)

  • decrease of hemoglobin level

    postoperative day 1, before hosptital discharge and 1 month after the operation

  • decrease of serum albumin level

    postoperative day 1, before hosptital discharge and 1 month after the operation

  • pleural effusion thickness

    observed through CT scan 1 month after the operation

Study Arms (2)

clamping group

EXPERIMENTAL

Clamping group are managed with clamping protocol after 3pm on the postoperative day as follow: the chest tube will be clamped, and the nurses will check the patient every 6 h. If the patient has no problems with compliance, the clamp will be removed for half an hour in the morning to record the drainage volume every 24 h.

Procedure: clamping group

control group

NO INTERVENTION

Patients in control group are managed with gravity drainage (water seal only, without suction) all the time after operation.

Interventions

clamping groupPROCEDURE

Clamping group are managed with clamping protocol after 3pm on the postoperative day as follow: the chest tube will be clamped, and the nurses will check the patient every 6 h. If the patient has no problems with compliance, the clamp will be removed for half an hour in the morning to record the drainage volume every 24 h.

clamping group

Eligibility Criteria

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

You may qualify if:

  • Pathological diagnosis of lung cancer Treated with lobectomy and systematic mediastinal lymph node dissection/ systematic sampling Managed with gravity drainage (water seal only, without suction) Re-expansion of the lung confirmed on the morning of the first postoperative day

You may not qualify if:

  • Thoracic cavity infection Prolonged air leakage Reoperation due to chylothorax Atelectasis Liver cirrhosis Renal insufficiency Wound infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (1)

  • Wang Y, Pei Y, Lv C, Wang Y, Wang J, Zhao D, Li X, Yang Y, Kim AW, Toker A, Yan S, Wu N. Intermittent chest tube clamping decreases chest tube duration time and drainage volume after lung cancer surgery in patients without air leak: an open-label, randomized controlled trial. Transl Lung Cancer Res. 2022 Mar;11(3):357-365. doi: 10.21037/tlcr-22-150.

    PMID: 35399576DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant of hospital director

Study Record Dates

First Submitted

September 30, 2017

First Posted

December 20, 2017

Study Start

July 26, 2017

Primary Completion

April 28, 2021

Study Completion

May 28, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations

CN(1)