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

NCT01395225 | Completed

• 1 other identifier: H11-00748
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Bladder Cancer; Transitional Cell Carcinoma

Keywords

Fat Emulsifying; Radical Cystectomy; Pelvic Lymph Node Dissection; Pathological Lymph Node Processing; Bladder Cancer; Transitional Cell Carcinoma; Urothelial Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with lymph node metastasis on pathologic examination

  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.

  2 years

Secondary Outcomes (1)

• Total number of lymph nodes and lymph node metastasis

  2 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to consent to study.
• Presence of concomitant malignancy.
• The use of neoadjuvant chemotherapy or radiation therapy.
• Prior pelvic surgery or radiation that may impair ability to perform adequate pelvic lymph node dissection.
• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Urologic Oncology Group: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (1)

• Koren 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 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Peter Black, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 15, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 13, 2014

Record last verified: 2014-03

Locations

CA (1)