10.1 Diagnostic & Staging Procedures: Imaging, Endoscopy, Biopsy & How They Are Coded
Key Takeaways
CT, MRI, PET/CT, ultrasound and bone scans supply clinical T, N and M information; a cancer diagnosed only by imaging plus a physician's statement has Diagnostic Confirmation code 7.
Endoscopic ultrasound assesses the depth of GI wall invasion and nearby nodes, and endobronchial ultrasound (EBUS) samples mediastinal and hilar lymph nodes for lung cancer N staging.
Diagnostic Confirmation [490] codes the best method at any time, in priority order for solid tumors: 1 histology, 2 cytology, 4 microscopic NOS, 5 lab/marker, 6 direct visualization, 7 imaging, 8 clinical, 9 unknown.
Surgical Diagnostic and Staging Procedure [1350] records only positive procedures: 01 biopsy of a site other than the primary, 02 biopsy of the primary site, 05 exploration with biopsy.
An excisional biopsy with clear or microscopically positive margins is coded as surgery of the primary site; regional lymph node biopsies are coded in Scope of Regional Lymph Node Surgery, not in item 1350.
Why procedures matter to the registrar
Every staging element comes from a procedure. The T category comes from exam, imaging, endoscopy or resection; the N category from imaging, node biopsy or dissection; the M category from imaging or biopsy of a distant site. Knowing what each test can and cannot show helps you assign the right time frame (clinical or pathological), the right Diagnostic Confirmation code and the right treatment or diagnostic item.
Imaging
| Procedure | What it shows | Common registry uses |
|---|---|---|
| Plain radiography (X-ray) | Density differences | Chest X-ray finding of a lung mass; bone lesions |
| Computed tomography (CT) | Cross-sectional anatomy, usually with contrast | Tumor size and extension; lymphadenopathy; liver, lung and adrenal metastases (clinical T, N and M) |
| Magnetic resonance imaging (MRI) | Soft-tissue detail | Rectal cancer T and circumferential margin, prostate (with PI-RADS), brain and spine, liver |
| PET/CT (usually FDG) | Metabolic activity, reported as SUV | Occult nodal and distant metastases in lung, lymphoma, head and neck, esophageal and other cancers; PSMA PET for prostate; somatostatin-receptor PET for neuroendocrine tumors |
| Ultrasound | Solid versus cystic lesions; guides biopsies | Thyroid nodules, breast (BI-RADS), liver, testis, axillary nodes |
| Mammography | Breast density, masses, calcifications | BI-RADS categories. STORE: BI-RADS alone is not reportable. |
| Bone scan (scintigraphy) | Areas of bone turnover | Bone metastases in prostate and breast cancer |
Imaging descriptors such as "enlarged," "suspicious" or "consistent with metastasis" are interpreted using the staging manual's rules. Summary Stage 2018 and AJCC each explain how to read ambiguous terms about involvement.
Endoscopy and minimally invasive staging
| Procedure | Purpose |
|---|---|
| Colonoscopy, sigmoidoscopy | Visualize and biopsy colorectal lesions; the distance from the anal verge locates rectal and sigmoid tumors |
| Esophagogastroduodenoscopy (EGD) | Esophagus, stomach and duodenum; biopsy |
| Endoscopic ultrasound (EUS) | Depth of wall invasion (uT) and nearby nodes in the esophagus, stomach, pancreas and rectum; EUS-guided FNA or core biopsy |
| Bronchoscopy; endobronchial ultrasound (EBUS) | Airway tumors; EBUS-TBNA samples mediastinal and hilar nodes for lung N staging |
| Mediastinoscopy | Surgical sampling of mediastinal nodes |
| Cystoscopy; TURBT | Bladder visualization; transurethral resection gives both diagnosis and depth of invasion |
| ERCP | Biliary and pancreatic ducts; brushings (cytology) and stents |
| Laparoscopy or thoracoscopy | Look for peritoneal or pleural spread; biopsy |
Biopsy methods
| Method | Specimen | Diagnostic Confirmation |
|---|---|---|
| Fine-needle aspiration (FNA) | Cells (cytology) | 2 (positive cytology) |
| Core needle biopsy | A cylinder of tissue (histology) | 1 (positive histology) |
| Incisional biopsy | Part of the tumor | 1 |
| Excisional biopsy | The whole visible lesion | 1 (may also be coded as treatment) |
| Punch or shave biopsy | Skin | 1 |
| Bone marrow aspirate and biopsy | Marrow cells and core | 1; for hematopoietic neoplasms, 3 if immunophenotyping or genetics is also positive |
| Sentinel lymph node biopsy | The first draining node(s) | Coded in Scope of Regional Lymph Node Surgery [1292] |
| Liquid biopsy (circulating tumor DNA) | Blood | A biomarker test; not tissue confirmation |
Tumor markers alone are never used for case ascertainment (SEER). A marker can be diagnostic (Diagnostic Confirmation 5) only when the test is clinically diagnostic for that specific cancer and a physician diagnoses the cancer.
STORE Diagnostic Confirmation [490]
The item records the best method of confirmation at any time in the patient's history. For solid tumors the codes are in priority order, and the item is updated if a more definitive method confirms the cancer later.
| Code | Label |
|---|---|
| 1 | Positive histology |
| 2 | Positive cytology |
| 3 | Positive histology plus positive immunophenotyping and/or genetic testing (hematopoietic and lymphoid neoplasms only) |
| 4 | Positive microscopic confirmation, method not specified |
| 5 | Positive laboratory test or marker study |
| 6 | Direct visualization without microscopic confirmation (surgery or endoscopy only) |
| 7 | Radiography and other imaging techniques without microscopic confirmation |
| 8 | Clinical diagnosis only (other than 5, 6 or 7) |
| 9 | Unknown whether microscopically confirmed |
For hematopoietic and lymphoid neoplasms there is no priority order. The specific type is usually diagnosed by immunophenotyping or genetic testing, so check the Heme DB for each disease's definitive diagnostic method.
STORE Surgical Diagnostic and Staging Procedure [1350]
This item tracks surgical resources used to diagnose or stage cancer that are not treatment. Record the procedure whether it was done at your facility or elsewhere, and only if it was positive for the reportable tumor.
| Code | Meaning |
|---|---|
| 00 | No surgical diagnostic or staging procedure |
| 01 | Biopsy (incisional, needle or aspiration) of a site other than the primary; no exploration |
| 02 | Biopsy of the primary site; or biopsy or removal of a lymph node to diagnose or stage lymphoma |
| 03 | Surgical exploration only; not biopsied or treated |
| 04 | Surgical procedure with a bypass, no biopsy |
| 05 | Exploratory procedure with biopsy of the primary or another site |
| 06 | Bypass procedure with biopsy |
| 07 | Procedure done, type unknown |
| 09 | No information |
Key boundaries from STORE:
- If an incisional biopsy of the primary and a biopsy of a metastatic site are both done, use 02.
- Excisional biopsies with clear or microscopically positive margins are coded as surgery (Rx Summ – Surg 2023 [1291]), not here. A procedure that leaves macroscopic (gross) tumor behind is coded here.
- A needle biopsy followed by an excision or more extensive surgery stays a needle biopsy in item 1350.
- Regional lymph node aspiration, biopsy or removal goes in Scope of Regional Lymph Node Surgery [1292], not item 1350. The exception is a node removed to diagnose lymphoma.
- Brushings, washings, cell aspirations and blood smears are cytology (Diagnostic Confirmation 2), not surgical procedures.
- Palliative procedures go in Palliative Care [3270].
Worked examples
- A needle biopsy of a liver metastasis confirms colon cancer, and the patient receives palliative chemotherapy: 1350 = 01; Diagnostic Confirmation = 1.
- An exploratory laparotomy finds unresectable pancreatic cancer with a biopsy of the pancreatic head: 1350 = 05.
- Unresectable gastric cancer, biopsy of the primary, then a gastrojejunostomy bypass: 1350 = 06. The bypass is also recorded in Palliative Care if it was done to relieve symptoms.
- A lung mass seen on CT, a physician's statement of lung cancer, and no tissue: Diagnostic Confirmation 7.
A patient with suspected widespread colon cancer undergoes a CT-guided needle biopsy of a liver lesion that shows metastatic adenocarcinoma. No exploratory surgery is performed. How is Surgical Diagnostic and Staging Procedure [1350] coded?
00, because needle biopsies are recorded in Diagnostic Confirmation only
01, because a biopsy was done to a site other than the primary site
02, because the biopsy confirmed the primary cancer
05, because the biopsy was image-guided
Which procedure is used specifically to sample mediastinal and hilar lymph nodes for lung cancer N staging?
Endoscopic retrograde cholangiopancreatography (ERCP)
Transurethral resection of bladder tumor (TURBT)
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
Colonoscopy with polypectomy
A frail patient's chest CT shows a spiculated mass with mediastinal adenopathy. The pulmonologist documents "lung cancer, clinical stage III; no biopsy per patient wishes." What Diagnostic Confirmation code applies?
1, positive histology
6, direct visualization without microscopic confirmation
7, radiography and other imaging techniques without microscopic confirmation
9, unknown whether microscopically confirmed
Sections you finish are checked off in the contents.