Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

According to the standard of care, patients in this arm will receive a radical prostatectomy with a standard bilateral ePLND. This includes the removal of lymph nodes within the obturator fossa and bilateral to the external iliac artery, internal iliac artery and common iliac artery up to the ureteral-vessel crossing.

Patients in this arm will undergo a radical prostatectomy without a bilateral extended pelvic lymph node dissection. In case of intraoperatively found suspicious lymph nodes, a lymphadenectomy is performed. According to the intention to treat principle, patients with intraoperatively removed lymph nodes remain included in the study.

Bilateral extended pelvic lymph node dissection

Pelvic lymph node dissection

Henk G van der Poel, Prof

Hilda A de Barros, MD

H.G van der Poel, Prof

An extended pelvic lymph node dissection (ePLND) is the most accurate staging method to assess the presence of lymph node metastases in prostate cancer (PCa) patients. The therapeutic value, however remains unclear. Prospective randomized trials to address this void are lacking. Since in intermediate and a proportion of high risk PCa the risk of nodal metastases is generally below 25%, the vast majority of men undergo a procedure that has no oncological benefit, but is not without toxicity.

Therefore, the investigators aim to compare the oncologic outcomes of intermediate- and high-risk PCa patients with an estimated risk of lymph node invasion of 5-20% undergoing a radical prostatectomy (RP) with or without an ePLND.

The role of an extended pelvic lymph node dissection (ePLND) in patients undergoing radical prostatectomy (RP) remains controversial. An ePLND is the most accurate staging method to assess the presence of lymph node metastases. Lymph node involvement is associated with a significantly worse prognosis and may require immediate or delayed adjuvant therapy. However, an ePLND is associated with an increased risk of complications such as lymphoceles, thromboses and lymphedema, and prolongs surgery and patient recovery. Thus, the diagnostic advantage of PLND should be weighed against the potential morbidity.

The therapeutic value of an ePLND remains especially unclear in PCa patients with an estimated risk of lymph node invasion (LNI) ≤ 20%, where only a minority of patients will have nodes harbouring metastases. Prospective trials to address this issue are still lacking.

The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

Prospective Randomized Controlled Trial To Evaluate The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

Persistent PSA is defined as a PSA value ≥ 0.1 ng/ml after radical prostatectomy

BCR is defined as a PSA value ≥ 0.2 ng/ml after radical prostatectomy

This is defined as the time between radical prostatectomy to development of metastasis

According to Clavien-Dindo classification

I.e., androgen deprivation therapy, radiation therapy or salvage lymph node dissection

Quality of life (QoL) will be assessed with the EORTC Core Quality of Life questionnaire's (QLQ-C30) global QoL scale ranging from 0 to 100, higher scores indicate better QoL

Health-related quality of life in prostate cancer patients will be assessed with the EORTC Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25) with a scale ranging from 0 to 100, higher scores indicate either more symptoms (urinary, bowel, hormonal treatment-related symptoms) or higher levels of (sexual) activity or functioning

Urinary continence will be assessed with the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) questionnaire, ranging from 0 (best) to 21 (worst)

Urinary voiding symptoms will be assessed with the International Prostatic Symptoms Score (IPSS), ranging from 0 (best) to 35 (worst)

Potency will be assessed with the International Index of Erectile Function (IIEF) questionnaire. The IIEF classifies the severity of erectile dysfunction into five categories stratified by score:

No erectile dysfunction. Score: 26-30 Mild erectile dysfunction. Score: 22-25 Mild to moderate erectile dysfunction. Score: 17-21 Moderate erectile dysfunction. Score: 11-16 Severe erectile dysfunction. Score: 6-10.

The Netherlands Cancer Institute

Symptoms and General Pathology

Blood and Lymph Conditions

Postoperative Complications

Lymphocele

Cysts

Lymphatic Diseases

In the intervention group, a ventral fixation was performed by suturing the ventral bladder peritoneum to the plexus Santorini and from there to the right and left lateral endopelvic fascia (MICHL-stitch).

Michl-stitch

Uwe Michl

A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent robot-assisted radical prostatectomy with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention.

MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles

Prospective Randomised Study to Examine the Influence of a Modification of the DaVinci Prostatectomy on the Frequency of Postoperative Lymphoceles Requiring Treatment and Postoperative Complications

A publication in a peer-reviewed journal is planned

Martini-Klinik am UKE GmbH

Radical prostatectomy with extended pelvic lymph node dissection

ePLND is performed either before or after radical prostatectomy and includes the removal of all nodal and fibro-fatty tissue

Radical prostatectomy (RP) followed by ePLND

Radical prostatectomy (RP) only

Cyrill A. Rentsch, MD-PhD

For patients with intermediate-risk prostate cancer plus a predicted risk of \>5% for positive lymph nodes and with high-risk prostate cancer, international guidelines recommend ePLND along with the RP. Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. We hypothesize that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.

Radical prostatectomy (RP) is the surgical standard treatment for men with localized prostate cancer (PCa) and a life expectancy of \> 10 years. RP is a treatment option for localized PCa that shows benefit in prostate cancer-specific survival (PCSS) and overall survival compared to conservative management. According to the guideline recommendations of the European Association of Urology (EAU), RP should be accompanied by extended pelvic lymph node dissection (ePLND) in patients with intermediate-risk PCa (D'Amico classification) and \> 5% nomogram (Briganti) predicted risk of positive lymph nodes and in all high-risk PCa cases.

Besides an improved accuracy in staging, the therapeutic role of ePLND remains controversial. The primary goal of this trial is to provide high-level evidence regarding the therapeutic benefit of ePLND in intermediate- and high-risk PCa patients without clinical evidence of nodal involvement. It is hypothesized that ePLND prolongs time to biochemical recurrence (BCR) and prostate cancer-specific survival (PCSS) in intermediate- and high-risk PCa patients.

SAKK 09/18 is an international, multicenter, randomized, phase III surgical intervention trial

Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer

Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer: An International, Multicenter, Randomized Phase III Trial

The primary endpoint of this trial is time to BCR, defined as time from randomization to biochemical recurrence, defined as serum PSA level ≥ 0.2 ng/ml, with a second confirmatory serum PSA level ≥ 0.2 ng/ml. Patients not experiencing an event will be censored at the date of the last available assessment or at the start of adjuvant or salvage treatment, if any.

PSA persistence is defined as failure to reach a PSA value of \<0.1 ng/ml within 12 weeks (+ 2 weeks) postoperatively.

Patients with no assessments within the first 12 weeks (+ 2 weeks) after surgery will be counted as failures for this endpoint

Time to initiation of adjuvant or salvage therapies will be calculated as the time from randomization to the start of any type of adjuvant or salvage therapy. Patients not starting adjuvant or salvage therapies are censored at the last date they were known to be alive.

Time to loco-regional recurrence will be calculated from randomization until local (prostate bed) or regional (extent of ePLND template) recurrence, whichever occurs first. Patients not experiencing an event will be censored at the date of the last available assessment or at the start of adjuvant or salvage therapy, if any.

Time to distant metastasis will be calculated from randomization until first occurrence of distant metastasis. Patients not experiencing an event will be censored at the date of the last available assessment.

PCSS will be calculated as the time from randomization to the date of death due to prostate cancer. Patients who died due to other reasons will be censored at the time of death. All other patients will be censored at the last date they were known to be alive.

Causes of death may require critical review by the coordinating investigator and the medical advisor. Particular attention will be paid to men who have been reported as having died from prostate cancer without previously reported progression or recurrence and men who were reported as having died from non-prostate cancer causes after developing biochemical or clinical progression.

OS will be calculated from randomization until death from any cause. Patients not experiencing an event will be censored at the last date they were known to be alive.

Intraoperative complications will be assessed using the CLASSIC system.

Postoperative complications will be assessed using the Clavien-Dindo classification.

AEs will be assessed according to NCI CTCAE v5.0.

Swiss Group for Clinical Cancer Research

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Respiratory Tract Infections

Coagulants

All Drugs and Chemicals

Hemostatics

Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.

Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.

J-Plasma

Vipul R Patel, MD

This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based plasma technology in the reduction of lymphoceles following pelvic lymph node dissection (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to prevent lymph leakage.

Participants evaluated and scheduled for a PLND during Robotic Assisted Radical Prostatectomy who have met the study inclusion criteria and who have also given informed consent will be enrolled. Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. An abdominal-pelvic ultrasound will be completed at a follow-up period ranging from 4-12 weeks post operatively to determine if a lymphocele is present. The occurrence rate of lymphoceles in this trial group will be compared to retrospective data from the principal investigator's practice and other published data to determine if the occurrence rate has been reduced.

Cold Plasma for the Reduction of Lymphoceles Following PLND

Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy

The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.

AdventHealth

Apyx Medical

Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.

J-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Pre-Op Prostate-Specific Antigen (PSA)

Gleason scores range from 2 to 10, and most prostate cancer will score 6 or higher. A higher score (8 to 10) means the type of cancer has a higher risk of growing and spreading.

Pre-Operative Biopsy Gleason

Kari Larson

Number of Participants With Incidence of Lymphocele Formation

Overall Study

Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

Intuitive Vessel Sealer

Ronney Abaza, MD, FACS

The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si robotic surgical system. It is intended for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of the instrument. Their use in this study will be to perform tissue transection during PLND such that the intended use is within the FDA-approved domain for this instrument. Investigators intend to identify whether its use for PLND reduces lymphoceles given that the device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels encountered during PLND. Because the instrument is new and has been FDA approved for less than one year, there is no published literature regarding its use to date.

Our hypothesis is that using the Vessel Sealer on a single side of the pelvis will reduce the incidence of screening detected lymphoceles on that side. Investigators propose a total sample size of 120 patients.

Investigators propose a prospective, randomized, single-blinded study of patients diagnosed with pelvic cancer who are electing to undergo robotic surgery with PLND. The patients in our trial will be pelvic cancer patients at risk for lymphocele after PLND. Given the safe nature of the product and the patient's risk for lymphocele after PLND and subsequent potential morbidity, there is justification to give patients the option for inclusion in the study. Investigators intend to determine whether the rate of lymphocele formation after PLND at the time of robotic pelvic cancer surgery can be reduced by using the robotic Vessel Sealer unilaterally for the lymph node dissection. The side of the pelvis of each patient will be randomly selected by Excel's® random number function "RAND()" to receive the Vessel Sealer dissection. Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control and eliminate patient specific confounding variables such as BMI, and surgeon specific factors such as degree and method of hemostasis utilized by each surgeon. In addition, Dr. Abaza will be the only surgeon performing these procedures, eliminating variation in technique between surgeons.

Prevention of Lymphoceles After Robotic PLND

A Pilot Clinical Trial for the Prevention of Lymphoceles After Robotic Pelvic Lymph Node Dissections for Prostate Malignancies Using the da Vinci® EndoWrist® One™ Vessel Sealer

Identify whether the use of the Vessel Sealer for PLND reduces the incidence of screening detected lymphoceles via CT scan of the pelvis by comparing the Vessel Sealer side of the pelvis with the control side of the pelvis.

Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include "no complications" (0), "minor complications" (1), and "major complications" (2).

Intuitive Surgical

OhioHealth

Medical Director Robotic Surgery

Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

Study Participants

Dr. Ronney Abaza

The null hypothesis is that there is no difference in the incidence of detected lymphoceles whether the EndoWrist 1 Vessel Sealer or the Fenestrated Maryland BiPolar Instrument were used.

Lymphoceles

No Lymphoceles

Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.

The EndoWrist 1 Vessel Sealer was utilized on one side of the body, with each participant receiving both treatments, one each side.

EndoWrist 1 Vessel Sealer

The Fenestrated Maryland BiPolar Instrument was utilized on one side of the body, with each participant receiving both treatments, one each side.

Fenestrated Maryland BiPolar Instrument

Lymphoceles were identified by CT scan at 3 months post surgery.

Incidence of Lymphoceles

Surgical Complications

Carcinoma

Urinary Bladder Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Antineoplastic Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Gemcitabine

Methotrexate

Cisplatin

Vinblastine

Participants who are deemed eligible for cisplatin-based NAC will undergo:

* Standard of care neoadjuvant systemic therapy (currently cisplatin-based chemotherapy in cisplatin-eligible participants)
* Partial cystectomy with extended pelvic lymph node dissection
* Standard of care adjuvant systemic therapy in eligible patients

Participants who are deemed ineligible for cisplatin-based NAC will undergo:

* Partial cystectomy with extended pelvic lymph node dissection
* Standard of care adjuvant systemic therapy in eligible participants

Standard of care neoadjuvant systemic therapy is currently cisplatin-based chemotherapy in cisplatin-eligible participants. Participants will start treatment within 60 days of Transurethral Resection of Bladder Tumor. Regimens may include:

* Cisplatin - Gemcitabine (Gem/Cis)
* Dose Dense Methotrexate - Vinblastine - Adriamycin - Cisplatin (MVAC)

Neoadjuvant Chemotherapy

Partial cystectomy will then be performed using the surgical technique at the discretion of the treating Urologic Oncologist. Extended pelvic lymphadenectomy will then be performed at the discretion of the treating Urologic Oncologist. Surgery will be performed within 60 days of Transurethral Resection of Bladder Tumor for Cisplatin-ineligible participants. Surgery will be performed within 60 days of completing neoadjuvant chemotherapy for Cisplatin-eligible participants.

Partial cystectomy with Extended pelvic lymph node dissection

Standard of care adjuvant systemic therapy in eligible participants. The choice of adjuvant systemic therapy will be left to the discretion of the treating Medical Oncologist but must fall within the SOC as outlined in NCCN guidelines.

Adjuvant systemic therapy

Nima Almassi, MD

The goal of this clinical trial is to determine if a partial cystectomy with extended pelvic lymph node removal will be effective at treating Muscle-Invasive Bladder Cancer instead of a complete cystectomy with extended pelvic lymph node removal. This clinical trial aims to determine the safety and oncologic efficacy of the intervention, and to examine patient-reported quality of life outcomes in participants. Participants will receive the standard pre-surgery treatment for approximately 4 to 6 weeks. After the pre-surgery treatment is completed, participants will undergo a partial cystectomy with extended pelvic lymph node dissection. After surgery, participants will receive adjuvant systemic therapy.

Radical cystectomy (surgical removal of the bladder) with pelvic lymph node dissection and urinary diversion, with neoadjuvant chemotherapy in eligible participants, is the standard of care in participants with muscle-invasive bladder cancer (MIBC). While this has demonstrated efficacy in the treatment of MIBC, it has risk of perioperative morbidity and impacts quality of life. Partial cystectomy (surgical removal of a portion of the bladder) is one option for bladder-sparing treatment of select bladder cancer participants and is included in the National Comprehensive Cancer Network bladder cancer treatment guidelines. This treatment has the advantage of less invasive treatment with a lower risk of surgical complication and better health-related quality of life (HRQOL) while providing pathologic staging, however there are limited data on outcomes with this treatment, especially patient-reported HRQOL outcomes. Additionally, much of the existing literature on efficacy of this treatment predates the use of advanced imaging in preoperative staging and advances in surgical technique including use of minimally-invasive surgical approaches and enhanced-recovery post-operative care paths. Given these limitations in the existing literature, the aim of this clinical trial is to examine the safety and efficacy and HRQOL outcomes of partial cystectomy with extended pelvic lymph node dissection, with standard of care perioperative systemic therapy in eligible participants.

This is a single-center, prospective, phase II trial.

Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy

Phase II Trial on the Safety and Efficacy of Partial Cystectomy and Extended Pelvic Lymph Node Dissection With Standard of Care Perioperative Systemic Therapy in the Management of Muscle-Invasive Bladder Cancer (PRESERVE Trial)

Recurrence-Free Survival (RFS) is defined as the time from post-surgery baseline scan (revealing no recurrent/metastatic disease) until the first occurrence of either local or distant recurrence as assessed by CT or MRI and/or biopsy. The primary outcome of distant RFS will be assessed via Kaplan-Meier analysis

The Clavien-Dindo classification will measure post-operative complications. The Clavien-Dindo Classification of Post-operative Complications is a tool to assess complications following surgical treatment. This tool ranks complications on a scale of seven levels, with level 1 being the least complicated and 7 being the worst complication resulting in death. The average classification at 90 days will be assessed and reported.

The median duration of bladder recurrence-free survival at 2 years.

The median duration of muscle-invasive bladder recurrence-free survival at 2 years.

The median duration of bladder-intact survival at 2 years.

The median duration of cancer-specific survival at 2 years.

The mean changes in Genitourinary-specific HRQoL will be reported. The HRQoL survey is composed of five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea and vomiting, pain), a global health status/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The scales and single-item measures range from 0 - 100, with higher values representing a higher response level.

Case Comprehensive Cancer Center

Rare Diseases

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

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.

Peter Black, MD

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.

PURPOSE:

This research aims to compare the clinical significance of the use of a fat emulsifying protocol versus the current standard in the processing of lymph node specimens following radical cystectomy and pelvic lymph node dissection.

HYPOTHESIS:

The investigators hypothesize that the use of a fat-emulsifying protocol in the processing of lymph nodes harvested at the time of radical cystectomy will increase the proportion of patients found to have lymph node metastases when compared to the current standard technique.

JUSTIFICATION:

The mainstay of management of muscle invasive bladder cancer is radical cystectomy with pelvic lymph node dissection (PLND). Despite optimal multimodal therapy, approximately half of patients with invasive bladder cancer die of their disease. Efforts to improve patient outcome have focussed on two principle factors: the delivery of pre-operative chemotherapy and the adequacy of PLND. While a PLND is ultimately defined by its anatomic extent, a popular surrogate measure of extent is the number of lymph nodes removed. Beyond assessing the adequacy of the PLND in the sense of quality of care, the accurate determination of lymph node involvement is essential for the correct staging of the patient, which is used to guide adjuvant therapy and determine patient prognosis. The processing and analysis of the lymph node specimens is therefore critical in multiple ways.

The current convention at Vancouver General Hospital for specimen handling involves the dissection of the nodal specimen by a laboratory technologist in the pathology lab. Only palpable nodes are processed for sectioning and the remaining fat tissue is discarded. The nodal count is determined by the pathologist when reviewing the slides based on a combination of the macroscopic and microscopic examination. This process is highly subjective, depends on the diligence of the technologist's dissection, and limits the final examination to palpable nodes. In the fat emulsifying technique, all fat is dissolved so that the pathologist can visualize and process all nodes. The investigators believe that this may provide for a more standardized and reproducible method in processing lymph nodes.

A standardized and reproducible method for processing lymph nodes is a prerequisite to any use of lymph node counts as a measure of the quality of the PLND. And, it is necessary to allow the comparison of results between centers. Furthermore, standardized methodology is essential to ensure adequate sampling of lymph nodes for clinical staging and prognostication.

OBJECTIVES:

The investigators have designed a prospective trial to compare our current protocol for processing pelvic lymph nodes from radical cystectomy with PLND to a fat-emulsifying protocol. The investigators aim to answer three questions with this trial:

i. While the fat-emulsifying technique will almost certainly identify more nodes than the current technique of manual dissection, and will likely identify more nodal metastases, the aim of this study is to determine whether a more careful analysis will find a greater proportion of patients to have lymph node metastases. This will translate into better staging and prognostication.

ii. The current technique likely misses particularly small lymph nodes that are not easily palpated. The investigators hypothesize that there is no threshold lymph node size below which the risk of metastasis is negligible, and that identification of these smaller nodes is therefore clinically meaningful.

iii. The investigators hypothesize that a fat-emulsifying protocol will remove much of the variability due to human element of manual dissection by the prosector. While the investigators will not test this hypothesis directly, the investigators believe the methodology and photographic documentation of the results will reflect a degree of objectivity in this methodology that is not seen with other techniques.

The ultimate goal of this research proposal is to develop a standardized and reproducible technique that can be used everywhere in order to enhance the care of our patients with invasive bladder cancer.

RESEARCH METHOD:

Patients:

All patients who undergo radical cystectomy with pelvic lymph node dissection at Vancouver General Hospital (VGH) will be invited to participate in this prospective study. Patients with clinical stage T1-4,N0,M0 bladder cancer will be invited to participate in the study and will be enrolled after informed consent is obtained.

Surgical technique:

The extent of lymph node dissection will be defined as either conventional (up to bifurcation of common iliac artery) or extended (at least up to the aortic bifurcation) and will be determined by the surgeon on a case-by-case basis. Dissection of the pre-sacral lymph nodes is also up to the surgeon. Objective documentation of the extent of node dissection will be assured by intra-operative photography in every case.

Pathologic processing of PLND specimen:

Each specimen will be analyzed by both conventional means and by a fat-emulsifying protocol. The current convention at Vancouver General Hospital for specimen handling is described above. In this study the pathologist will count the number of nodes dissected by the prosector according to this current protocol. The tissue remaining after removal of the grossly palpable lymph nodes will be submitted for processing by the fat-emulsifying protocol, which is identical to the LNRS ("lymph node removing solution") protocol defined by Koren et al. This consists of placement of the entire specimen in a specialized solution for 12 hours. The solution is a mixture of 95% ethanol, diethyl ether, glacial acetic acid and buffered formalin in a ratio by volume of 6.5:2:0.5:1 Specimens so treated will be photographed for objective documentation of the nodal count. The additional nodes are then embedded in paraffin, sectioned at 2 mm intervals, and stained with eosin and hematoxylin. The total number of nodes, their size and presence of metastasis will be recorded.

Data collection:

Demographic, clinical and pathological information will be recorded prospectively. Demographic variables analyzed will include: age, sex, weight, height and race. Clinical variables will include: date of cancer diagnosis, clinical and pathologic stage at diagnosis and at time of surgery (TNM staging), date of radical cystectomy, history of intravesical chemotherapy, other medical co-morbidities and prior abdominal surgeries, extent of lymph node dissection, and complications during the procedure. Pathological variables will be recorded for the findings on both the conventional and fat-emulsifying protocols. The number, size and presence of metastasis for each node found will be recorded.

STATISTICAL ANALYSIS:

Outcome measure:

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 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.

Sample size calculation:

An increase in the identification of nodal metastases by 15% (fat-emulsifying compared to conventional processing) will be considered clinically significant. The current rate of node positivity at the time of radical cystectomy with PLND at VGH is 28%, so that an increase to 43% would be deemed clinically relevant. To detect this difference with a power (1-β) of 80% and an α error of 10%, 125 patients will need be enrolled in each arm of the study.

Analysis of Data:

Data will be analyzed using SPSS software. The independent samples t-test will be used to compare the results from the lymph node analysis when processed by conventional means versus the same nodes processed using the fat-emulsifying protocol (p\<0.5). The relationship of size to presence of metastatic disease will be done by linear regression model (p\<0.5). A significant difference between the groups will be defined as p\<0.05. A biostatistician (Robert Bell) at the Vancouver Prostate Centre will assist with data analysis.

SUMMARY

The investigators have the opportunity with simple and inexpensive technical processing measures to enhance an integral component of our clinical risk stratification in patients with invasive bladder cancer. The investigators can establish a solid foundation in pelvic lymph node counting upon which clinical concepts of lymph node yield and density can be validated. The investigators expect to demonstrate that the fat-emulsifying protocol is easy to adopt, reproducible and suitable for widespread use. It has the potential to impact every patient undergoing radical cystectomy with PLND.

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

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 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.

Canadian Urologic Oncology Group

University of British Columbia

Edema

Lymphedema

Genital Diseases, Female

Oculocerebral Syndrome With Hypopigmentation

Myong Cheol Lim, MD,PhD

The purpose of this study is to identify the incidence,feature,clinical significance for leg lymphedema after gynecologic cancer treatment.

Medical records will reviewed. And all patients who met the inclusion criteria will contacted by a telephone call by a clinical research coordinator. The telephone interview questionnaire for Lower Extremity Edema (LEE) and gynecologic cancer lymphedema questionnaire (GCLQ) will t take approximately 20-30 min to complete. The questionnaire for LEE included onset, severity, location, duration, and management. Patients will also questioned concerning deep vein thrombosis to exclude other causes of LEE. LEE is defined as subjective edema of lower extremity based on patients' complaint. LLL is defined based on a clinical diagnosis of lymphedema by a physician.

Cross-sectional and Questionnaire Study for Leg Lymphedema

The Cross-sectional and Questionnaire Study of Pelvic and Lower Extremity Lymphedema After Treatment of Gynecological Disease

There are no more follow up except one time telephone interview.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy	NCT05109910	Prostate Cancer	Pelvic lymph no...	18 Years -	The Netherlands Cancer Institute
MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles	NCT06284135	Lymphocele Afte...	Michl-stitch	18 Years -	Martini-Klinik am UKE GmbH
Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer	NCT03921996	Prostate Cancer	Radical prostat... Radical prostat...	18 Years - 80 Years	Swiss Group for Clinical Cancer Research
Cold Plasma for the Reduction of Lymphoceles Following PLND	NCT02658851	Lymphoceles Fol...	J-Plasma	18 Years - 80 Years	Apyx Medical
Extended Pelvic Lymph Node Dissection vs. no Pelvic Lymph Node Dissection at Radical Prostatectomy for intermediate-and High-risk Prostate Cancer	NCT03921996	Prostate Cancer	Radical prostat... Radical prostat...	18 Years - 80 Years	Swiss Group for Clinical Cancer Research
Prevention of Lymphoceles After Robotic PLND	NCT02035475	Lymphoceles Prostate Cancer	Intuitive Vesse...	18 Years -	OhioHealth
Partial Cystectomy & Extended Pelvic Lymph Node Dissection With SOC Perioperative Systemic Therapy	NCT06290687	Malignant Neopl... Muscle Invasive...	Neoadjuvant Che... Partial cystect... Adjuvant system...	19 Years -	Case Comprehensive Cancer Center
Lymph Node Processing Protocol for Radical Cystectomy and Pelvic Lymph Node Dissection in Bladder Cancer	NCT01395225	Bladder Cancer Transitional Ce...		18 Years -	University of British Columbia
Lymph Node Processing Protocol for Radical Cystectomy and Pelvic Lymph Node Dissection in Bladder Cancer	NCT01395225	Bladder Cancer Transitional Ce...		18 Years -	University of British Columbia
MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles	NCT06284135	Lymphocele Afte...	Michl-stitch	18 Years -	Martini-Klinik am UKE GmbH
Cross-sectional and Questionnaire Study for Leg Lymphedema	NCT02069171	Gynecologic Can...		18 Years -	National Cancer Center, Korea

Spots Global Cancer Trial Database for pelvic lymph node dissection