Clinical trial · Observational
Lymph Node Processing Protocol for Radical Cystectomy and Pelvic Lymph Node Dissection in Bladder Cancer
Standardising an Approach for Analysis of Lymph Node Specimens From Radical Cystectomy With Pelvic Lymph Node Dissection Through the Use of an Organic Fat-emulsifying Agent
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
When the bladder is removed for bladder cancer, pelvic lymph nodes (LN) are also removed. While the anatomic extent of this LN dissection is critical, the investigators often use the number of LN removed as a measure of the extent, which in turn is essential for determining the patient's further treatment and prognosis. The LN count, however, is also dependent on the pathologist's processing of the LN tissue, and the standards for this processing are poorly defined. The goal of this study is to establish a standardized method for processing and analyzing lymph node specimens. The investigators hypothesize that if an organic solvent is used to remove excess fat from the lymph nodes that the investigators will discover more clinically significant nodes in a more reproducible fashion when compared to the current method.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Transitional Cell Carcinoma | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- All Patients
- description
- There will be no separate cohorts in this study. All patients will have their specimens processed by conventional means and by the study method. The conventional means will be the control for the study method.
Primary outcomes (1)
- measure
- Proportion of patients with lymph node metastasis on pathologic examination
- timeFrame
- 2 years
- description
- The primary outcome will be the proportion of patients found to have lymph nodes metastases on pathologic examination. Specifically, the difference in proportion of specimens found to contain nodal metastases using the fat-emulsifying protocol compared to the conventional lymph node processing will be analyzed.
Secondary outcomes (1)
- measure
- Total number of lymph nodes and lymph node metastasis
- timeFrame
- 2 years
- description
- Secondary outcome measures will be: the total number of lymph nodes and the total number of lymph node metastases counted by both techniques and the relationship between the size of lymph node and the presence of metastatic carcinoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients who undergo radical cystectomy with lymph node dissection at the Vancouver General Hospital (VGH) for clinical stage T1-4,N0,M0 bladder cancer will be invited to participate in this prospective study. Exclusion Criteria: 1. Inability to consent to study. 2. Presence of concomitant malignancy. 3. The use of neoadjuvant chemotherapy or radiation therapy. 4. Prior pelvic surgery or radiation that may impair ability to perform adequate pelvic lymph node dissection. 5. If a patient is enrolled but does not undergo a lymph node dissection (for example due to other intraoperative complications), the patient will be excluded from analysis.
References
Publications (1)
- BACKGROUNDKoren R, Paz A, Lask D, Kyzer S, Klein B, Schwartz A, Gal R. Lymph-node revealing solution: a new method for detecting minute lymph nodes in cystectomy specimens. Br J Urol. 1997 Jul;80(1):40-3. doi: 10.1046/j.1464-410x.1997.00154.x. PMID 9240178