Robot-assisted Surgical Resection vs. Cryoablation of Localised Renal Cancer

NCT03390413 | Withdrawn DMC

• 1 other identifier: UFE-1-10-72-140-17
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The present study is a randomized clinical trial which investigates robot-assisted partial nephrectomy (RPN) compared to image-guided cryoablation (CA) in a number of functional, oncological and economic variables. Every year close to 1000 Danes are diagnosed with renal cell carcinoma. Approximately 25% of these newly diagnosed patients have a T1a tumour, thus being candidates to nephron-sparing surgery. Today most nephronsparing surgical procedures consists of RPN, often requiring temporary clamping of the renal artery rendering the kidney to a critical period of warm ischemia which is potentially harmful to the renal function. Image guided ablative modalities has emerged as a minimal-invasive alternative to partial nephrectomy. The level of evidence within this domain is considered to be low as the existing literature is highly influenced by selection bias, and as of yet no randomized trial has compared the two modalities. Especially with the increasing age of the patients, an approach suitable for local anaestesia is desirable. Patients from Central Denmark Region and Region of Southern Denmark who are diagnosed with a pT1a renal cell carcinoma that is found to be eligible for both modalities will be offered to enter into a randomized trial to be treated with either RPN og CA. The study's primary endpoint is loss of renal function 6 and 12 month after treatment. Secondary endpoint includes recurrence free survival 1, 3 and 5 years after treatment, readmission and complication rates as well as health economic evaluations. All patients will be pre- and postoperatively assessed with biochemistry, CT urography, CT thorax and glomerular filtration rate measurements.

Conditions

Renal Cancer

Keywords

Cryoablation; Robot-assisted surgical resection

Outcome Measures

Primary Outcomes (1)

• Renal function

  Loss of renal function measured by Chrome-EDTA clearence 6 months post-operatively in each treatment modality

  6 months

Secondary Outcomes (3)

• Incomplete ablation

  3 months

• Complications

  90 days

• Costs

  90 days

Study Arms (2)

Robot

ACTIVE COMPARATOR

Procedure: Robot

Cryo

EXPERIMENTAL

Procedure: Cryoablation

Interventions

Robot PROCEDURE

Renal cancer treated with robotic surgery

Robot

Cryoablation PROCEDURE

Renal cancer treated with cryoablation

Cryo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-time biopsy confirmed RCC
• ECOG Performance Status between 0 and 2
• The tumour is found to be eligible for both RPN and CA
• e-GFR\> 60 ml/min/1.74 m2
• Written consent after oral and written information has been given

You may not qualify if:

• Impaired renal function (e-GFR \<59 ml/min/1.74m2)
• Previously diagnosed with RCC
• Patients with recognized genetic mutations that directly relate to RCC (eg. Von Hippel Lindau, BHD)
• Allergy to contrast agents
• Pregnancy
• Expected remaining life \<12 months
• Active treatment of secondary cancer disease

Sponsors & Collaborators

• Jørgen Bjerggaard Jensen: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (3)

• Mitropoulos D, Artibani W, Biyani CS, Bjerggaard Jensen J, Roupret M, Truss M. Validation of the Clavien-Dindo Grading System in Urology by the European Association of Urology Guidelines Ad Hoc Panel. Eur Urol Focus. 2018 Jul;4(4):608-613. doi: 10.1016/j.euf.2017.02.014. Epub 2017 Mar 7.

  PMID: 28753862 BACKGROUND

• Vind-Kezunovic S, Bouchelouche K, Ipsen P, Hoyer S, Bell C, Bjerggaard Jensen J. Detection of Lymph Node Metastasis in Patients with Bladder Cancer using Maximum Standardised Uptake Value and 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography: Results from a High-volume Centre Including Long-term Follow-up. Eur Urol Focus. 2019 Jan;5(1):90-96. doi: 10.1016/j.euf.2017.06.005. Epub 2017 Jun 23.

  PMID: 28753817 BACKGROUND

• Nielsen TK, Jensen JB. Efficacy of commercialised extracorporeal shock wave lithotripsy service: a review of 589 renal stones. BMC Urol. 2017 Jul 27;17(1):59. doi: 10.1186/s12894-017-0249-8.

  PMID: 28750620 BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 4, 2018
• Study Start: September 1, 2019
• Primary Completion: March 1, 2023
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)