NCT04656769

Brief Summary

The choice of analgesia after cancer surgery may play a role in the onset of recurrence, particularly opioids seem to play a role in the immune system by promoting cancer cell proliferation and migration. Based on this consideration, our aim was to assess the impact of perioperative analgesia's choice on cancer recurrence after curative surgery for Stage I Non-Small Cell Lung Cancer. The investigators retrospectively reviewed the records of patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012. Patients received analgesia either by peridural (PERI group) or, in case of patient refusal or failure in catheter positioning, intravenous analgesia with opioids (EV group). Follow-up was concluded in August 2019. The five-year cumulative incidence of recurrence and the overall survival were evaluated and adjusted with a propensity score matching methodology.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
382

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

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

December 17, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
Last Updated

December 21, 2020

Status Verified

December 1, 2020

Enrollment Period

1.3 years

First QC Date

November 30, 2020

Last Update Submit

December 18, 2020

Conditions

Keywords

Recurrence tumorOpioid useAnalgesiathoracic surgery

Outcome Measures

Primary Outcomes (1)

  • cumulative incidence of recurrence and the overall survival

    5 years

Study Arms (2)

PERI group

Procedure: Peridural analgesia

EV group

Interventions

We attempted to evaluate the effectiveness of peridural analgesia through cancer survival and recurrence outcomes.

PERI group

Eligibility Criteria

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

Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012

You may qualify if:

  • Age ≥ 18 yrs
  • Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012

You may not qualify if:

  • Age\<18aa
  • Pregnancy
  • Day hospital patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza di Torino

Torino, 10100, Italy

Location

MeSH Terms

Conditions

RecurrenceAgnosia

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Luca Brazzi, Professor

    University of Torino

    STUDY CHAIR
  • Giulio L Rosboch, MD

    A.O.U. Città della Salute e della Scienza

    PRINCIPAL INVESTIGATOR
  • Ilaria De Domenici, MD

    University of Torino

    STUDY DIRECTOR
  • Edoardo Ceraolo, MD

    A.O.U. Città della Salute e della Scienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 30, 2020

First Posted

December 7, 2020

Study Start

December 17, 2018

Primary Completion

April 1, 2020

Study Completion

November 30, 2020

Last Updated

December 21, 2020

Record last verified: 2020-12

Locations