Lymph Node Processing Protocol for Radical Cystectomy and Pelvic Lymph Node Dissection in Bladder Cancer

This study has been completed.
Sponsor:
Collaborator:
Canadian Urologic Oncology Group
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01395225
First received: July 13, 2011
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition
Bladder Cancer
Transitional Cell Carcinoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Proportion of patients with lymph node metastasis on pathologic examination [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Total number of lymph nodes and lymph node metastasis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 32
Study Start Date: August 2011
Study Completion Date: December 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
All Patients
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395225

Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Canadian Urologic Oncology Group
Investigators
Principal Investigator: Peter Black, MD University of British Columbia
  More Information

Publications:
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01395225     History of Changes
Other Study ID Numbers: H11-00748
Study First Received: July 13, 2011
Last Updated: March 12, 2014
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by University of British Columbia:
Fat Emulsifying
Radical Cystectomy
Pelvic Lymph Node Dissection
Pathological Lymph Node Processing
Bladder Cancer
Transitional Cell Carcinoma
Urothelial Cell Carcinoma

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 25, 2014