Resection or Ablation of Small Kidney Tumors

NCT06278506 | Recruiting DMC

• 1 other identifier: 4612
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer.

Conditions

Kidney Cancer

Outcome Measures

Primary Outcomes (3)

• Number of participants with surgical complications according to Clavien-Dindo grade 2-5

  recorded through chart review at 30 and 90 days after treatment. Complications are summed up in case of retreatment before the 12-month follow-up.

  First year after inclusion

• Radiological signs of a residual tumor at the 6-month follow-up

  Radiological sign of residual tumor at 6-month radiology

  6-month after inclusion

• Number of postoperative hospitalization days (LOS)

  Number of postoperative hospitalization days (LOS), i.e., the time the patient has been hospitalized after the procedure until discharge. Hospitalization time is accumulated in case of retreatment within 12 months.

  Sum of total after all interventions first year after the first intervention

Secondary Outcomes (3)

• Cancer-specific survival (CSS)

  2, 5 and 10 years after inclusion

• Overall survival (OS)

  2, 5 and 10 years after inclusion

• Change in eGFR one year after treatment

  One year after inclusion

Study Arms (2)

Ablation

EXPERIMENTAL

Ablative treatment of small kidney cancer lesion, could be given with radiofrequency, microwawe or cryoablation

Procedure: Ablation

Partial nephrectomy

ACTIVE COMPARATOR

Surgical resection with open or laparoscopic technique

Procedure: Surgery

Interventions

Ablation PROCEDURE

Microwave ablation, Radiofrequency ablation, Cryo ablation

Also known as: Microwave ablation, Radiofrequency ablation, Cryo ablation

Ablation

Surgery PROCEDURE

Partial or total nefrectomy

Also known as: Partial nefrectomy, total nefrectomy

Partial nephrectomy

Eligibility Criteria

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

You may qualify if:

• Age 18 - 99 years
• Patient suitable based on clinical status for both ablative treatment and surgery
• Primary kidney tumor
• Tumor size ≤ 3 cm
• Clinical stage of the tumor T1a (no macroscopic vascular or extrarenal invasion)
• Tumor location suitable for both ablative treatment and resection
• Absence of radiological signs of metastasis
• Biopsy with malignant pathological analysis (PAD)
• ISUP grade I-III"

You may not qualify if:

• Radiological signs of metastasis
• Synchronous kidney tumors
• ISUP grade IV or sarcomatoid growth in the biopsy
• Other metastasized cancer in the last 5 years
• Patient unable to make an informed decision to participate in the study

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Radiofrequency Ablation; Surgical Procedures, Operative

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)

Radiofrequency Therapy; Therapeutics; Ablation Techniques

Study Officials

• Anders Kjellman, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anders Kjellman, MD, PhD

CONTACT

+46736995258; anders.kjellman@regionstockholm.se

Per-Olof Lundgren, MD, PhD

CONTACT

Study Design

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

Model Details: RCT

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 26, 2024
• Study Start: January 31, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2037
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

SE (1)