Lithuanian Colorectal Cancer Implementation Guide
0.0.1 - ci-build Lithuania vėliava

Lithuanian Colorectal Cancer Implementation Guide, published by Lithuanian Medical Library. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7LT/ig-lt-colorectal/ and changes regularly. See the Directory of published versions

Workflow

Dabartiniam puslapiui nėra vertimo puslapio, todėl jis pateiktas numatytąja kalba

Colorectal Cancer Screening Workflow

This page describes the clinical workflow modeled by the Lithuanian Colorectal Cancer Prevention Implementation Guide. The pathway follows the national colorectal cancer early diagnosis programme (ADP).

Overview

The colorectal cancer screening pathway consists of three sequential stages, each producing structured FHIR resources:

  1. Fecal Occult Blood Testing (FOBT) – primary screening with immunochemical stool testing
  2. Colonoscopic Examination – diagnostic colonoscopy with polyp/tumor assessment
  3. Pathological Histological Examination – tissue analysis from biopsy or polypectomy specimens

All colonoscopy results are linked into a single Colonoscopy Composition wrapped by a Colonoscopy Report. Pathology results use profiles from the Laboratory IG.

1. Fecal Occult Blood Testing (FOBT)

Eligible individuals aged 50–75 are invited to participate in the screening programme. The primary screening method is a fecal immunochemical test (FIT) for occult blood in stool.

Profile: ObservationFecalOccultBloodTestResultLtColorectal

Two test types are supported (from FOBT Test Codes):

  • Qualitative (LOINC 80372-6) – rapid immunoassay, result: detected / not detected (from FOBT Qualitative Result)
  • Quantitative (LOINC 27396-1) – immunochemical measurement in microg/l

A stool specimen is collected and documented. If FOBT is negative, the patient is re-invited after 2 years. If FOBT is positive (blood detected), the patient is referred for colonoscopy.

Examples:

2. Colonoscopic Examination

Patients with positive FOBT are referred for diagnostic colonoscopy. The colonoscopy examination documents the procedure, bowel preparation quality, anatomical reach, findings (polyps, tumors), complications, and conclusions.

2.1 Colonoscopy Procedure

The colonoscopy is recorded as a Colonoscopy Procedure. Key data elements include:

  • Whether the procedure was performed with or without anesthesia
  • Whether a video colonoscope was used
  • Withdrawal time
  • Whether the colonoscopy was postponed

Examples:

2.2 Colonoscope Reach

The endoscopist documents the most distal anatomical segment reached using the Colonoscope Reach profile.

The Colonoscope Reach ValueSet includes anatomical sites from terminal ileum through to the anal canal. This data is used to calculate the caecum intubation rate quality indicator.

Examples:

2.3 Bowel Preparation Assessment

Bowel preparation quality directly affects mucosal visualization and is assessed using the Bowel Preparation Quality profile with the Boston Bowel Preparation Scale (BBPS).

The profile captures:

  • Overall quality: effective, inadequate, or not done (from Bowel Preparation Quality VS)
  • BBPS segment scores (0–3 each) for left colon, transverse colon, and right colon (from BBPS Score Values)
  • Total BBPS score (0–9): quality is poor when < 6 points, or when at least one segment scores 0 or 1

Additional preparation details may be documented:

  • Substances used (from Bowel Preparation Substances): Macrogol 4000, Macrogol 3350, sodium picosulfate combination, sodium sulfate
  • Whether the patient received written information about preparation
  • Whether split-dose preparation was used
  • Whether targeted dietary recommendations were given (for poor preparation)

Examples:

2.4 Polyp Findings

Individual polyps are documented using the Polyp Finding profile with components for:

  • Location – anatomical site with SMSA scoring (2 points for proximal, 1 point for distal)
  • Paris classification – morphological type (from Paris Classification VS): Is, ISP, IP, IIa, IIb, IIc, and LST subtypes
  • NICE classification – endoscopic histology prediction (from NICE Classification VS): Type I (hyperplastic), Type II (adenoma), Type III (invasive cancer)
  • Size – largest dimension in mm
  • Access to polyp – Easy or Heavy (from Polyp Access VS)
  • SMSA score – calculated composite score from location + Paris + size + access
  • Predicted histology – hyperplastic, SSL, adenoma, or adenoma with suspicion of malignancy (from Polyp Predicted Histology VS)

Photo documentation is linked via derivedFrom references to Media/DocumentReference resources (minimum 2 photos per polyp: white light and chromoendoscopy).

​When a polyp is removed, a Polypectomy Procedure is recorded with details about the removal method (from Polypectomy Method VS): snare loop, pliers, hot/cold method, en bloc or in parts, and hydropreparation technique.

If the polyp is sent for histological examination, the biopsy procedure, sample number, and pathology response are tracked. The adenoma detection rate quality indicator is calculated from pathology results.

Examples:

2.5 Tumor Findings

Tumors identified during colonoscopy are documented using the Tumor Finding profile, capturing the anatomical location and free-text description. Tumor biopsy is performed using BiopsyProcedureLtLab from the Lab IG, with samples sent for histological examination.

Examples:

2.6 Complications

Complications are documented at two levels:

  1. Complication presence – Colonoscopy Complication Presence records whether any complication occurred (Yes/No)

  2. Complication type – Colonoscopy Complication Type records the specific complication: hemorrhage of colon, complication of anesthesia, accidental organ perforation, or perforation of large intestine

  3. Wall integrity violation – Colonoscopy Wall Injury Detail documents wall damage using the Sydney deep mural injury classification (Types I–V from Sydney Classification VS) and the action taken (clipping, suturing, or primary operation from Wall Injury Action VS)

  4. Bleeding control – Colonoscopy Bleeding Control documents interventions such as adrenaline injection or clipping

Examples:

2.7 Conclusions

The colonoscopy conclusion is documented using Colonoscopy Conclusion with a coded finding from the Colorectal Conclusion VS, which includes approximately 30 SNOMED-coded findings: normal colonoscopy, polyps, malignant tumor, inflammatory bowel disease (ulcerative colitis, Crohn's disease), ischemic colitis, diverticulosis, hemorrhoids, bleeding of unknown origin, angiectasia, and others.

Examples:

3. Pathological Histological Examination

Tissue specimens collected during colonoscopy (from biopsy or polypectomy) are sent for histological examination. This stage reuses profiles from the Laboratory IG for specimen management, tumor measurement, and pathology reporting, with colorectal-specific extensions.

3.1 Specimen and Pre-Analytic Data

Specimens are documented using SpecimenLtLab with container number, type of material (polypectomy/biopsy), and localization from the endoscopy. Tissue blocks are tracked using SpecimenBlockLtLab. Specimen quality is assessed using SpecimenAdequacyLtLab: sufficient for research, limited informativeness, or insufficient.

3.2 Macroscopic Examination

The largest dimension of the tissue fragment is recorded using SpecimenMeasurementLtLab. Additional macroscopic findings are captured as free text.

3.3 Histological Diagnosis

The colorectal-specific Histological Diagnosis profile captures the structured diagnosis with components for:

Non-invasive processes (from Histological Diagnosis VS):

  • Conventional adenoma: tubular, tubulovillous, villous
  • Serrated polyps: hyperplastic polyp (HP), sessile serrated lesion (SSL), SSL with dysplasia, traditional serrated adenoma (TSA)
  • Other polyps, benign non-epithelial tumors (lipoma, leiomyoma), ulcer, colitis

Malignant tumors:

  • Primary carcinoma: adenocarcinoma (NOS, mucinous, signet ring, medullary, serrated, micropapillary, adenosquamous, undifferentiated, pseudosarcomatous)
  • Other: neuroendocrine carcinoma (NEC), neuroendocrine tumor (NET), GIST, melanoma, lymphoma, sarcoma, metastases

Additional assessment components:

  • Dysplasia grade (from Dysplasia Grade VS): no dysplasia, low grade, high grade / pTis
  • Radicalism of removal (from Radicalism of Removal VS): R0 (clear margins), R1 (involved margins), RX (cannot be assessed), not applicable
  • Tumor budding (from Tumor Budding VS): Bd0, Bd1 (1–4/20X), Bd2 (5–9/20X), Bd3 (10+/20X)
  • Invasion depth (from Invasion Depth VS): Haggitt 0–4, Kikuchi Sm1–Sm3
  • MMRP expression (from MMRP Expression VS): normal (MSS), loss of expression (MSI), invaluable, postponed
  • Intravascular invasion: assessed using LymphovascularInvasionVS from Lab IG
3.4 Molecular Research

Molecular testing for microsatellite instability (MSI), KRAS, NRAS, and BRAF V600E mutations is indicated for adenocarcinoma. Each test is recorded as a separate Molecular Test Result observation.

Test types (from Molecular Test Type VS):

  • MSI (KLTN XLT00915-2) – microsatellite instability study
  • KRAS – KRAS gene mutation analysis
  • NRAS – NRAS gene mutation analysis
  • BRAF V600E (KLTN XLT00914-5) – BRAF gene V600 variant study

Results (from Molecular Test Result VS): Postponed, Detected mutation, Undefined mutation, or Set (MSI).

Examples:

3.5 Pathology Report

The synoptic pathology report follows the Pathology Composition structure from the Laboratory IG, organized into four LOINC-coded sections:

  1. Pre-Analytic (LOINC 22636-5): clinical context, service request, procedure, and submitted specimens
  2. Macroscopic (LOINC 74574-5): gross specimen measurements, specimen adequacy, paraffin blocks
  3. Microscopic (LOINC 660-1): histological diagnosis, grading, invasion assessment
  4. Synthesis (LOINC 22637-3): final diagnosis with ICD-10 and ICD-O-3 coding

The final Pathology Report includes mandatory ICD-10 coding and optional ICD-O-3 morphology coding in conclusionCode.

4. Screening Episode Composition

All colonoscopy results are linked into a single structured document – the Colonoscopy Composition.

The composition sections include:

  • Procedure – colonoscopy procedure, polypectomy procedures, bleeding control procedures
  • Findings – colonoscope reach, bowel preparation quality, polyp findings, tumor findings, complication presence and type, wall injury details
  • Conclusions – colonoscopy conclusion observations
  • Histopathology – references to Pathology Reports from the Lab IG
  • Lifestyle Factors – cross-IG references to Lifestyle IG (tobacco use, alcohol consumption, nutrition)
  • Vital Signs – cross-IG references to VitalSigns IG (BMI)

The composition is wrapped by the Colonoscopy Report which aggregates all structured results.

Quality Indicators

The screening programme defines the following quality indicators, computable from the structured data:

Indicator Denominator Numerator
Caecum intubation rate All screening colonoscopies Procedures where colonoscope reached cecum or terminal ileum
Quality of bowel preparation Patients who underwent screening Patients with BBPS total score >= 6
Adenoma Detection Rate Total screening colonoscopies Procedures where at least one adenoma was found (from pathology)
Proper Polypectomy Technique Polyps > 3mm removed during endoscopy Polyps removed with a snare loop
Early complications rate Screening colonoscopies Bleeding and wall integrity damage during colonoscopy
7-day hospitalization rate Screening colonoscopies Hospitalizations within 7 days after colonoscopy
Mortality rate Screening colonoscopies Deaths within 30 days after colonoscopy
Interval cancer rate Screening colonoscopies Colorectal cancer occurrence within 10 years