This is the current release of the guideline.

This guideline updates a previous version: Tan BB, Flaherty KR, Kazerooni EA, Iannettoni MD. The solitary pulmonary nodule. Chest 2003 Jan;123(1 Suppl):89S-96S.

Definitions for the strength of evidence and recommendation grades (1A-2C) follow the recommendations.

1. In every patient with a solitary pulmonary nodule (SPN), we recommend that clinicians estimate the pretest probability of malignancy either qualitatively by using their clinical judgment or quantitatively by using a validated model. Grade of recommendation, 1C
2. In every patient with an SPN that is visible on chest radiography (CXR), we recommend that previous CXRs and other relevant imaging tests be reviewed. Grade of recommendation, 1C
3. In patients who have an SPN that shows clear evidence of growth on imaging tests, we recommend that tissue diagnosis should be obtained unless specifically contraindicated. Grade of recommendation, 1C
4. In a patient with an SPN that is stable on imaging tests for at least 2 years, we suggest that no additional diagnostic evaluation be performed, except for patients with pure ground-glass opacities on CT, for whom a longer duration of annual follow-up should be considered. Grade of recommendation, 2C
5. In a patient with an SPN that is calcified in a clearly benign pattern, we recommend no additional diagnostic evaluation. Grade of recommendation, 1C
6. In every patient with an indeterminate SPN that is visible on CXR, we recommend that CT of the chest should be performed, preferably with thin sections through the nodule. Grade of recommendation, 1C
7. In every patient with an indeterminate SPN that is visible on chest CT, we recommend that previous imaging tests should be reviewed. Grade of recommendation, 1C
8. In a patient with normal renal function and an indeterminate SPN on CXR or chest CT, we recommend that CT with dynamic contrast enhancement be considered in centers with experience performing this technique. Grade of recommendation, 1B
9. In patients with low-to-moderate pretest probability of malignancy (5 to 60%) and an indeterminate SPN that measures at least 8 to 10 mm in diameter, we recommend that F-18 fluorodeoxyglucose (FDG)-positron emission tomography (PET) imaging should be performed to characterize the nodule. Grade of recommendation, 1B
10. In patients with an SPN that has a high pretest probability of malignancy (> 60%), or patients with a subcentimeter nodule that measures < 8 to 10 mm in diameter, we suggest that FDG-PET not be performed to characterize the nodule. Grade of recommendation, 2C
11. In every patient with a SPN, we recommend that clinicians discuss the risks and benefits of alternative management strategies and elicit patient preferences. Grade of recommendation, 1C
12. In patients with an indeterminate SPN that measures at least 8 to 10 mm in diameter and who are candidates for curative treatment, observation with serial CT scans is an acceptable management strategy in the following circumstances:
    • When the clinical probability of malignancy is very low (< 5%)
    • When clinical probability is low (< 30 to 40%) and the lesion is not hypermetabolic by FDG-PET or does not enhance > 15 Hounsfield units (HU) on dynamic contrast CT
    • When needle biopsy is nondiagnostic and the lesion is not hypermetabolic by FDG-PET
    • When a fully informed patient prefers this nonaggressive management approach

    Grade of recommendation, 2C

13. In patients who have an indeterminate SPN that measures at least 8 to 10 mm in diameter and undergo observation, we suggest that serial CT scans be repeated at least at 3, 6, 12, and 24 months. Grade of recommendation, 2C
14. In patients who have an indeterminate SPN that measures at least 8 to 10 mm in diameter and are candidates for curative treatment, it is appropriate to perform a transthoracic needle biopsy or bronchoscopy in the following circumstances:
    • When clinical pretest probability and findings on imaging tests are discordant; for example, when the pretest probability of malignancy is high and the lesion is not hypermetabolic by FDG-PET
    • When a benign diagnosis requiring specific medical treatment is suspected
    • When a fully informed patient desires proof of a malignant diagnosis before surgery, especially when the risk of surgical complications is high

    In general, we suggest that transthoracic needle biopsy be the first choice for patients with peripheral nodules unless the procedure is contraindicated or the nodule is inaccessible. We suggest that bronchoscopy be performed when an air bronchogram is present or in centers with expertise in newer guided techniques.

    Grade of recommendation, 2C

15. In surgical candidates with an indeterminate SPN that measures at least 8 to 10 mm in diameter, surgical diagnosis is preferred in most circumstances, including:
    • When the clinical probability of malignancy is moderate to high (> 60%)
    • When the nodule is hypermetabolic by FDG-PET imaging
    • When a fully informed patient prefers undergoing a definitive diagnostic procedure

    Grade of recommendation, 1C

16. In patients with an indeterminate SPN in the peripheral third of the lung and chose surgery, we recommend that thoracoscopy be performed to obtain a diagnostic wedge resection. Grade of recommendation, 1C
17. In a patient who chooses surgery with an indeterminate SPN that is not accessible by thoracoscopy, bronchoscopy, or transthoracic needle aspiration (TTNA), we recommend that a diagnostic thoracotomy be performed. Grade of recommendation, 1C
18. In patients who undergo thoracoscopic wedge resection for an SPN that is found to be cancer by frozen section, we recommend that anatomic resection with systematic mediastinal lymph node sampling or dissection be performed during the same anesthetic. Grade of recommendation, 1C
19. In patients who have an SPN who are judged to be marginal candidates for lobectomy, we recommend definitive treatment by wedge resection/segmentectomy (with systematic lymph node sampling or dissection). Grade of recommendation, 1B
20. For the patient who has an SPN and is not a surgical candidate and prefers treatment, we recommend that the diagnosis of lung cancer be confirmed by biopsy, unless contraindicated. Grade of recommendation, 1C
21. For the patient who has a malignant SPN and is not a surgical candidate and prefers treatment, we recommend referral for external-beam radiation or to a clinical trial of an experimental treatment such as stereotactic radiosurgery or radiofrequency ablation. Grade of recommendation, 2C
22. For surgical candidates who have subcentimeter nodules and no risk factors for lung cancer, the frequency and duration of follow-up (preferably with low-dose CT) should depend on the size of the nodule. We suggest the following:
    • Nodules that measure up to 4 mm in diameter not be followed up, but the patient must be fully informed of the risks and benefits of this approach
    • Nodules that measure > 4 to 6 mm be re-evaluated at 12 months without additional follow-up if unchanged
    • Nodules that measure > 6 to 8 mm be followed up sometime between 6 and 12 months, and then again between 18 and 24 months if unchanged

    Grade of recommendation, 2C

23. For surgical candidates who have subcentimeter nodules and one or more risk factors for lung cancer, the frequency and duration of follow-up (preferably with low-dose CT) should depend on the size of the nodule. We suggest the following:
    • Nodules that measure up to 4 mm in diameter be re-evaluated at 12 months without additional follow-up if unchanged
    • Nodules that measure > 4 to 6 mm should be followed up sometime between 6 and 12 months and then again between 18 and 24 months if unchanged
    • Nodules that measure > 6 to 8 mm be followed up initially sometime between 3 months and 6 months, then subsequently between 9 and 12 months, and again at 24 months if unchanged.

    Grade of recommendation, 2C

24. For surgical candidates with subcentimeter nodules that display unequivocal evidence of growth during follow-up, we recommend that definitive tissue diagnosis be obtained by surgical resection, transthoracic needle biopsy, or bronchoscopy. Grade of recommendation, 1C
25. For individuals who have subcentimeter nodules and are not candidates for curative treatment, we recommend limited follow-up (in 12 months) or follow-up when symptoms develop. Grade of recommendation, 1C
26. In patients who are candidates for curative treatment with a dominant SPN and one or more additional small nodules, we recommend that each nodule be evaluated individually, as necessary and curative treatment should not be denied unless there is histopathologic confirmation of metastasis. Grade of recommendation, 1C
27. In surgical candidates with a solitary pulmonary metastasis, we recommend that pulmonary metastasectomy be performed if there is no evidence of extrapulmonary malignancy and there is no better available treatment. Grade of recommendation, 1C
28. In surgical candidates with an SPN that has been diagnosed as small cell lung cancer (SCLC), we recommend surgical resection with adjuvant chemotherapy, provided that noninvasive and invasive staging exclude the presence of regional or distant metastasis. Grade of recommendation, 1C
29. In patients who have an SPN and in whom SCLC is diagnosed intraoperatively, we recommend anatomic resection (with systematic mediastinal lymph node sampling or dissection) under the same anesthesia when there is no evidence of nodal involvement and when the patient will tolerate resection. Surgery should be followed by adjuvant chemotherapy. Grade of recommendation, 1C

Definitions:

Quality of Evidence Scale

High - Randomized controlled trials (RCTs) without important limitations or overwhelming evidence from observational studies*

Moderate - RCTs with important limitations (inconsistent results, methodologic flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies*

Low or very low - Observational studies or case series

*Although the determination of magnitude of the effect based on observational studies is often a matter of judgment, the guideline developers offer the following suggested rule to assist this decision: a large effect would be a relative risk > 2 (risk ratio < 0.5) [which would justify moving from weak to moderate], and a very large effect is a relative risk > 5 (risk ratio < 0.2) [which would justify moving from weak to strong]. There is some theoretical justification in the statistical literature for these thresholds (the magnitude of effect that is unlikely or very unlikely to be due to residual confounding after adjusted analysis). However, once the decision is made, authors should be explicit in justifying their decisions.

Grade of Recommendations Scale

Relationship of Strength of the Supporting Evidence to the Balance of Benefits to Risks and Burdens

The following clinical algorithms are provided in the original guideline document:

• Recommended management algorithm for patients with SPNs that measure 8 to 30 mm in diameter
• Recommended management algorithm for patients with subcentimeter pulmonary nodules that measure < 8 mm in diameter

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Not applicable: The guideline was not adapted from another source.

2003 Jan (revised 2007 Sep)

American College of Chest Physicians - Medical Specialty Society

American College of Chest Physicians

American College of Chest Physicians (ACCP) Expert Panel on Lung Cancer Guidelines

Primary Authors: Michael K. Gould, MD, FCCP; James Fletcher, MD; Mark D. Iannettoni, MD, FCCP; William R. Lynch, MD; David E. Midthun, MD, FCCP; David P. Naidich, MD, FCCP; David E. Ost, MD, FCCP

American Association for Bronchology - Disease Specific Society
American Association for Thoracic Surgery - Medical Specialty Society
American College of Surgeons - Medical Specialty Society
American Society for Therapeutic Radiology and Oncology
Asian Pacific Society of Respirology - Disease Specific Society
Oncology Nursing Society - Professional Association
Society of Thoracic Surgeons - Medical Specialty Society
World Association of Bronchology - Disease Specific Society

This is the current release of the guideline.

This guideline updates a previous version: Tan BB, Flaherty KR, Kazerooni EA, Iannettoni MD. The solitary pulmonary nodule. Chest 2003 Jan;123(1 Suppl):89S-96S.

This NGC summary was completed by ECRI on June 30, 2003. The information was verified by the guideline developer on July 25, 2003. This NGC summary was updated by ECRI Institute on November 7, 2007. The updated information was verified by the guideline developer on December 21, 2007.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.