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NCT04656769 Clinical Trial

Analgesia aNd caNcer recUrrence Lung cAncer Resection

Analgesia Clinical Trial

Official title:
Impact of Analgesia on Cancer Recurrence and Mortality Within Five Years After Stage I Non-Small Cell Lung Cancer Resection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04656769
Other study ID # ANNULAR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 17, 2018
Est. completion date November 30, 2020

Study information
Verified date December 2020
Source University of Turin, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 382
Est. completion date November 30, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 yrs - Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012 Exclusion Criteria: - Age<18aa - Pregnancy - Day hospital patients

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Italy AOU Città della Salute e della Scienza di Torino Torino

Sponsors (1)
Lead Sponsor Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary cumulative incidence of recurrence and the overall survival 5 years
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