Lymph Node Dissection Before Or After Cystectomy (LBOACP)

July 28, 2023 updated by: Anna K. Czech, MD, Jagiellonian University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Krakow, Poland, 30-688
        • Recruiting
        • Department of Urology, University Hospital, Jagiellonian University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1 Lymph node dissection before bladder resection
Lymph node dissection will be performed before bladder resection during radical cystectomy
Other: Lymph node dissection before bladder resection
Lymph node dissection before bladder resection
Other: 2 Lymph node dissection after bladder resection
Lymph node dissection will be performed after bladder resection during radical cystectomy
Other: Lymph node dissection after bladder resection
Lymph node dissection after bladder resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early complications rate
Time Frame: Within 30 days after the surgery
Complications rate within 30 postoperative days
Within 30 days after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymph node yield
Time Frame: When pathology report is available (on average, the pathology report is available within 14 days after the surgery)
Number of lymph nodes removed
When pathology report is available (on average, the pathology report is available within 14 days after the surgery)
Operative time
Time Frame: At the end of the surgery (after the completion of skin closure and wound dressing)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative complications rate
Time Frame: At the end of the surgery (after the completion of skin closure and wound dressing)
Intraoperative complications rate
At the end of the surgery (after the completion of skin closure and wound dressing)
Positive surgical margin rate
Time Frame: When pathology report is available (on average, the pathology report is available within 14 days after the surgery)
Positive surgical margin rate
When pathology report is available (on average, the pathology report is available within 14 days after the surgery)
Ureters clamping time
Time Frame: At the end of the surgery (after the completion of skin closure and wound dressing)
Ureters clamping time
At the end of the surgery (after the completion of skin closure and wound dressing)
Postoperative estimated glomerular filtration rate (eGFR)
Time Frame: Within 7 days after the surgery
eGFR on postoperative day 1 and day 4-7
Within 7 days after the surgery
Complications severity and type
Time Frame: Within 30 days after the surgery
Severity and type of complications
Within 30 days after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Investigators

  • Principal Investigator: Anna K. Czech, Jagiellonian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBOACPUJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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