Lymph Node Dissection Before Or After Cystectomy

Bladder Cancer Clinical Trial

— LBOACP  

Official title:

Lymph Node Dissection Before Or After Cystectomy - Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939856
• Other study ID #: LBOACPUJ
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2023
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Jagiellonian University
• Contact: Anna K. Czech, M.D.
• Phone: +48124002500
• Email: aka.czech[@]uj.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare different ways of performing surgery for bladder cancer. Specifically, the goal is to determine whether it is better to remove the lymph nodes before removing the bladder or after removing the bladder during radical cystectomy. The study aims to answer two main questions: - Does the order of surgical steps during radical cystectomy affect the occurrence of complications after surgery? - Does the order of surgical steps during radical cystectomy impact the duration of the operation and the number of lymph nodes removed? Participants in the study will be randomly assigned to one of two groups. One group will undergo lymph node removal before bladder resection, while the other group will have lymph node removal after bladder resection during radical cystectomy. Throughout their hospital stay and for 30 days following the operation, participants will be closely monitored for various factors including operative details, pathology results, and any complications that may arise.

Description:

Lymph node dissection (LND) is an integral part of radical cystectomy (RC) for bladder cancer. LND provides important diagnostic and prognostic information, and according to most studies, is associated with therapeutic benefit. The optimal extent and template for LND in bladder cancer remains to be established. Currently, there are no specific recommendations regarding the sequence of lymph nodes removal and bladder resection during radical cystectomy, and the decision is based mainly on individual surgeon preference. The aim of the LBOAC pilot randomized trial is to evaluate the difference in intraoperative parameters and postoperative outcomes between patients undergoing LND before bladder resection during RC and those undergoing LND after bladder resection during RC. LBOAC is a pilot randomized controlled trial with two parallel groups. The primary objective of the trial is the comparison of complication rate within 30 postoperative days. Secondary objectives of LBOAC include comparing lymph node yield and operative time between the two groups. Data for will be collected using electronic case report forms (eCRFs) at baseline and within 30 days after the surgery. This pilot study is designed to test feasibility of, to support the refinements of the protocol and to aid in sample calculation that can be used for larger scale trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing radical cystectomy for bladder cancer in the Department of Urology University Hospital in Krakow

Exclusion Criteria:

• Previous pelvic lymph node dissection

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• Lymph node dissection before bladder resection
Lymph node dissection before bladder resection
• Lymph node dissection after bladder resection
Lymph node dissection after bladder resection

Locations

Country	Name	City	State
Poland	Department of Urology, University Hospital, Jagiellonian University	Krakow

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraoperative complications rate	Intraoperative complications rate	At the end of the surgery (after the completion of skin closure and wound dressing)
Other	Positive surgical margin rate	Positive surgical margin rate	When pathology report is available (on average, the pathology report is available within 14 days after the surgery)
Other	Ureters clamping time	Ureters clamping time	At the end of the surgery (after the completion of skin closure and wound dressing)
Other	Postoperative estimated glomerular filtration rate (eGFR)	eGFR on postoperative day 1 and day 4-7	Within 7 days after the surgery
Other	Complications severity and type	Severity and type of complications	Within 30 days after the surgery
Primary	Early complications rate	Complications rate within 30 postoperative days	Within 30 days after the surgery
Secondary	Lymph node yield	Number of lymph nodes removed	When pathology report is available (on average, the pathology report is available within 14 days after the surgery)
Secondary	Operative time	Total operative time, bladder resection time, lymph node dissection time	At the end of the surgery (after the completion of skin closure and wound dressing)