CONSERVE study

A feasibility study for a multicentre randomised controlled trial to compare surgery (partial nephrectomy) with needle ablation techniques (radiofrequency ablation/cryotherapy) for the treatment of people with small renal masses (4cm)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN23852951

Enrollment

Registered

2012-05-24

Start date

2012-06-15

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cancer

Interventions

Cryoablation, Participants in this study may be randomised to undergo cryoablation as treatment for their small renal mass

Partial Nephrectomy, Participants in this study may be randomised to undergo a partial nephrectomy as treatment for their small renal mass

Radiofrequency ablation, Participants in this study may be randomised to undergo radiofrequency ablation as treatment for their small renal mass

Follow Up Length: 6 month(s)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. ASA physical status classification system of 1 or 2 3. Radiological confirmation of (>20 Hounsfield Unit) enhancing renal mass (< 4cm) or biopsy proven renal cancer 4. CT abdomen/chest/pelvis with no enlarged nodes or distant metastases 5. Patient has provided written informed consent for participation in the study prior to any study specific procedures 6. Target Gender: Male & Female 7. Lower Age Limit 18 years

Exclusion criteria

Exclusion criteria: 1. Coagulopathy 2. Concomitant disease that would render the patient unsuitable for the study 3. Presence of urosepsis 4. Cancer which is completely buried in the kidney 5. More than one small renal cancer mass 6. Previous participation in this study 7. Inability to give informed consent; carer/proxy assent will not be allowed in this study

Design outcomes

Primary

Measure	Time frame
To estimate the number of patients with a renal mass <4cm who agree to trial randomisation measured at over 18 months of recruitment	—

Secondary

Measure	Time frame
1. Evaluation of treatment of tumour by CT scan and biopsy measured at using CT scans at 1, 3 and 6 months after treatment and renal biopsy at 6 months 2. Qualitative interview responses for after treatment for patients who are eligible measured at eight to sixteen weeks after treatment 3. Qualitative interview responses for patients who decline randomisation measured at two to sixteen weeks after recruitment interaction 4. Quality of Life questionnaire reporting differences measured within 14 days of randomisation, and at 3 months and 6 months follow-up	—

Measure

Time frame

1. Evaluation of treatment of tumour by CT scan and biopsy measured at using CT scans at 1, 3 and 6 months after treatment and renal biopsy at 6 months 2. Qualitative interview responses for after treatment for patients who are eligible measured at eight to sixteen weeks after treatment 3. Qualitative interview responses for patients who decline randomisation measured at two to sixteen weeks after recruitment interaction 4. Quality of Life questionnaire reporting differences measured within 14 days of randomisation, and at 3 months and 6 months follow-up

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026