Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2021-09-27
2022-05-18
Brief Summary
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Patients undergoing RN will enter a two-arm prospective single-center randomized controlled trial (RCT), comparing a no-touch RN technique, with direct pedicle ligation (Group A) vs. the more conventional approach of kidney traction and manipulation to reach the renal pedicle before its ligation (Group B).
A microfluidic size-based CTC isolation device will be used to capture and count CTCs from peripheral blood samples of these patients. CTCs will be identified by staining with antibodies to cytokeratin 8/18, vimentin, 4',6-diamidino-2-phenylindole (DAPI), and cluster of differentiation antigen 45 (CD45).
CTC release will be correlated with the disease-free survival (DFS), and overall survival (OS). The investigators will determine if CTC reducing no-touch radical nephrectomy technique improves these hard outcomes.
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Detailed Description
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Included patients will be referred to the Renal Cancer Unit of the North Lisbon University Hospital Center (CHLUN) Urology Department with the diagnosis of a renal mass eligible for a LRN. Patients will have their diagnosis confirmed, be appropriately staged, and their management options will be decided after a shared and informed decision process in light of the current European Association of Urology (EAU) Guidelines on RCC. Patients \< 18 years old and pregnant women will be excluded. Patients will be adequately informed of the study protocol, and will sign a specific informed consent.
Patients undergoing LRN will enter a two-arm prospective single-center randomized controlled trial, comparing a no-touch technique, with direct pedicle ligation (Group A) vs. the conventional dissection, and ligation of the renal pedicle with kidney traction (Group B). A peripheral blood sample will be collected at arrival to the operating room. After that, Group A patients will undergo a no-touch RN, with the dissection being done through the Gerota's fascia plane until exposure of the corresponding great vessel (vena cava on the right side, and aorta on the left side) is obtained. The renal pedicle will be directly isolated, and ligated using Weck® clips with no kidney manipulation. Group B patients will undergo a more conventional approach, starting with opening of the Gerota's fascia, identification of the ureter, traction on the peri-renal fat below the ureter while dissecting cephalad until the renal pedicle is reached. The renal pedicle will then be isolated while maintaining traction on the kidney, and peri-renal fat, and ligated using Weck® clips. A second peripheral blood sample will be collected at the time of specimen extraction. A third and fourth peripheral blood samples will be collected at post-operative days 1 and 30, respectively, to study CTC post-op kinetics. All samples will collect 7.5 mL of peripheral blood.
Patients presenting with hypofunctioning kidneys with indication for total nephrectomy will be used as controls. Total nephrectomy patients will undergo the randomization protocol, in a control arm.
The CTCs will be isolated from peripheral blood samples using a microfluidics size-based CTC capture device - Ruby™. Whole blood samples will be injected into the devices at an 80 µL/min flow rate. The CTCs captured on the devices will then be stained with antibodies to 4',6-diamidino-2-phenylindole (DAPI) to identify cell nuclei, cluster of differentiation antigen 45 (CD45) to identify leukocytes, cytokeratin 8/18 to identify epithelial CTCs, and vimentin to identify mesenchymal CTCs or CTCs which have undergone epithelial-to-mesenchymal transition. Blood samples will be processed no more than 30 minutes after collection.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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No-touch laparoscopic radical nephrectomy
Group A patients will undergo a no-touch laparoscopic radical nephrectomy, with the dissection being done through the Gerota's fascia plane until exposure of the corresponding great vessel (vena cava on the right side, and aorta on the left side) is obtained. The renal pedicle will be directly isolated, and ligated using Weck® clips with no kidney manipulation.
No-touch laparoscopic radical nephrectomy
We aim to determine if a laparoscopic no-touch nephrectomy with an early renal pedicle ligation can decrease CTC release during surgery.
Conventional laparoscopic radical nephrectomy
Group B patients will undergo a conventional laparoscopic radical nephrectomy approach, starting with opening of the Gerota's fascia, identification of the ureter, traction on the peri-renal fat below the ureter while dissecting cephalad until the renal pedicle is reached. The renal pedicle will then be isolated while maintaining traction on the kidney, and peri-renal fat, and ligated using Weck® clips.
Conventional laparoscopic radical nephrectomy
Conventional laparoscopic radical nephrectomy, which implies manipulation of the kidney, opening of the Gerota's fascia, and manipulation of peri-nephric fat during dissection, and renal pedicle isolation.
Laparoscopic total nephrectomy control arm
Control arm in which a laparoscopic total nephrectomy will be performed in patients with hypo-functioning kidneys, and no renal cell carcinoma.
Laparoscopic total nephrectomy control arm
Control arm in which a laparoscopic total nephrectomy will be performed in non-cancer patients.
Interventions
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No-touch laparoscopic radical nephrectomy
We aim to determine if a laparoscopic no-touch nephrectomy with an early renal pedicle ligation can decrease CTC release during surgery.
Conventional laparoscopic radical nephrectomy
Conventional laparoscopic radical nephrectomy, which implies manipulation of the kidney, opening of the Gerota's fascia, and manipulation of peri-nephric fat during dissection, and renal pedicle isolation.
Laparoscopic total nephrectomy control arm
Control arm in which a laparoscopic total nephrectomy will be performed in non-cancer patients.
Eligibility Criteria
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Inclusion Criteria
* Indication for laparoscopic radical nephrectomy
Exclusion Criteria
* Previous systemic therapy for renal cell carcinoma
* human immunodeficiency virus (HIV) positive
* Hepatitis C virus (HCV) positive
* hepatitis B virus (HBV) positive
18 Years
ALL
No
Sponsors
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Instituto de Medicina Molecular João Lobo Antunes
OTHER
Centro Hospitalar Lisboa Norte
OTHER
Hospital de Santa Maria, Portugal
OTHER
Responsible Party
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Tito Palmela Leitão
MD
Principal Investigators
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Tito P Leitão, MD
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina da Universidade de Lisboa
Locations
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Urology Department - Hospital de Santa Maria
Lisbon, Lisbon District, Portugal
Countries
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Other Identifiers
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0001
Identifier Type: -
Identifier Source: org_study_id
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