Smoking Cessation Before Bronchoscopy or CT-guided Puncture

NCT07322796 | Recruiting

• 1 other identifier: 25-251
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Nicotine is the most common preventable cause of death and is responsible for over seven million deaths worldwide. If current trends continue, tobacco will kill more than eight million people worldwide every year by 2030. Smoking tobacco products is the most important risk factor for the development of lung cancer. Passive smoking is also a major cause of lung cancer. Since July 2024, smokers and former smokers have been able to receive a low-radiation CT scan under certain conditions to detect lung cancer at an early stage. It is therefore to be expected that the number of diagnoses of pulmonary lesions or nodules will increase in the near future. The risk of developing and dying from tobacco-related diseases is reduced once nicotine cessation begins. Screening all patients for tobacco use, e-cigarette use, and providing behavioral counseling and pharmacotherapy to quit smoking are among the most valuable preventive services we can offer in healthcare. Nicotine dependence can be estimated using the so-called Fagerström test. An additional evaluation of nicotine behavior can be carried out by testing cotinine in urine, a method that is used, for example, in the listing for lung transplantation. Cotinine is a degradation product of nicotine that can be detected in the urine of smokers and passive smokers. Cotinine levels in urine depend on the frequency and quantity of nicotine consumption. The half-life of cotinine is 16 to 22 hours, which means that half of the cotinine is excreted from the body after this time. Another marker that can be used as a measure of tobacco consumption is carboxyhaemoglobin (COHb). This is hemoglobin with carbon monoxide at the binding site for oxygen. The reference range for carboxyhaemoglobin is 0.4 - 1.6 %. In smokers, values of 3-10 % are still considered normal. In our department, the smoking status of patients is assessed upon first contact. Support options for smoking cessation are offered and, upon request, initiated. Previous studies have shown that smoking is a risk factor for complications after thoracic surgical procedures and that patients who underwent thoracic surgery quit smoking almost twice as often compared to patients who did not undergo surgery. However, to the best of our knowledge, there is currently no study regarding smoking cessation before intervention in patients with nodules needing clarification (bronchoscopy or CT-guided puncture). Therefore, the aim of the study is to support and monitor smoking cessation before intervention in patients with nodules needing further diagnosis (bronchoscopy or CT-guided puncture).

Conditions

Pulmonary Nodule, Solitary; Smoking Behaviors

Keywords

smoking; smoking cessation; pulmonary nodules

Outcome Measures

Primary Outcomes (1)

• Smoking Cessation

  Patients who visit our outpatient clinic for the purpose of investigating a pulmonary lesion that requires clarification, are asked during the medical history if they are active smokers. If the answer is yes, patients are strongly advised to stop smoking immediately. Support options for smoking cessation are presented and, if desired, a connection to a smoking cessation counseling program offered by the Federal Institute for Public Health ("rauchfrei ticket") is established. In addition, nicotine dependence is assessed using the Fagerström test, COHb is determined by blood gas analysis, and cotinine is determined in urine. The same parameters will bei measured after 2-4 weeks and 3 months. As primary outcome measure, the number of patients who are likely to be smoke-free at the end of the observation period will be assessed.

  From enrollment to the end of the observation period 3 months later

Secondary Outcomes (4)

• Analysis of demographic data

  Within 3 months

• Spirometry (Lungfunction)

  Within 3 Months

• Bodyplethysmography (Lungfunction)

  Within 3 months

• Diffusing capacity (lungfunction)

  Within 3 months

Study Arms (2)

Smoking cessated

Patients who have stopped smoking since they were informed that they have a pulmonary lesion that needs clarification or after the diagnosis of cancer was communicated.

Smoking not cessated

Patients who have not stopped smoking since they were informed that they have a pulmonary lesion that needs clarification or after the diagnosis of cancer was communicated.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Active smokers by the time of the initial presentation in our pneumological outpatient clinic for the clarification of a suspicious nodule

You may qualify if:

• The patient is an active smoker by the time of the initial presentation in our pneumological outpatient clinic for the clarification of a suspicious nodule

You may not qualify if:

• Current or past medically relevant illness or treatment that could affect the evaluability of the study.
• Expected lack of willingness to actively participate in study-related measures.

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Related Publications (8)

• Mustoe MM, Clark JM, Huynh TT, Tong EK, Wolf TP, Brown LM, Cooke DT. Engagement and Effectiveness of a Smoking Cessation Quitline Intervention in a Thoracic Surgery Clinic. JAMA Surg. 2020 Sep 1;155(9):816-822. doi: 10.1001/jamasurg.2020.1915.

  PMID: 32609348 BACKGROUND

• Wong C, Mohamad Asfia SKB, Myles PS, Cunningham J, Greenhalgh EM, Dean E, Doncovio S, Briggs L, Graves N, McCaffrey N. Smoking and Complications After Cancer Surgery: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2025 Mar 3;8(3):e250295. doi: 10.1001/jamanetworkopen.2025.0295.

  PMID: 40053349 BACKGROUND

• Marrufo AS, Kozower BD, Tancredi DJ, Nuno M, Cooke DT, Pollock BH, Romano PS, Brown LM. Thoracic Surgeons' Beliefs and Practices on Smoking Cessation Before Lung Resection. Ann Thorac Surg. 2019 May;107(5):1494-1499. doi: 10.1016/j.athoracsur.2018.11.055. Epub 2018 Dec 23.

  PMID: 30586576 BACKGROUND

• Patnode CD, Henderson JT, Coppola EL, Melnikow J, Durbin S, Thomas RG. Interventions for Tobacco Cessation in Adults, Including Pregnant Persons: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021 Jan 19;325(3):280-298. doi: 10.1001/jama.2020.23541.

  PMID: 33464342 BACKGROUND

• Maciosek MV, Coffield AB, Edwards NM, Flottemesch TJ, Goodman MJ, Solberg LI. Priorities among effective clinical preventive services: results of a systematic review and analysis. Am J Prev Med. 2006 Jul;31(1):52-61. doi: 10.1016/j.amepre.2006.03.012.

  PMID: 16777543 BACKGROUND

• Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128.

  PMID: 23343063 BACKGROUND

• Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE; Lung Health Study Research Group. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005 Feb 15;142(4):233-9. doi: 10.7326/0003-4819-142-4-200502150-00005.

  PMID: 15710956 BACKGROUND

• Doll R, Peto R, Boreham J, Sutherland I. Mortality in relation to smoking: 50 years' observations on male British doctors. BMJ. 2004 Jun 26;328(7455):1519. doi: 10.1136/bmj.38142.554479.AE. Epub 2004 Jun 22.

  PMID: 15213107 BACKGROUND

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Smoking; Smoking Cessation; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Behavior; Health Behavior; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Michael Dreher Univ.-Prof. Dr.med

  University Hospital, Aachen

  STUDY DIRECTOR

Central Study Contacts

Maria Aetou Dr.med

CONTACT

00492418088763; maetou@ukaachen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr.Dr.med

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)