Renal Cell Carcinoma Stage IIINCT04350047
Renal Cell Carcinoma and Stage IV Inferior Vena Cava Thrombus: Resection Without Thoracotomy
An observational study of Renal Cell Carcinoma Stage III, run by Attikon Hospital at 1 site in Greece.
Trial summary
Assessment of short-term outcomes of radical nephrectomy combined with IVC thrombectomy with a novel technique without thoracotomy: single center case series. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma Stage III
- What is being tested?
- Radical nephrectomy with inferior vena cava thrombectomy without thoracotomy
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2018to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Among all patients with renal cell carcinoma operated in Attikon University Hospital, the ones with level IV tumor thrombus were included in the study.
Who may be able to join
- Adult patients
- Documented radiological and/or pathological diagnosis of renal cell carcinoma with level IV tumor thrombus
Who cannot join
- American Anesthesia Association (ASA) Class V and/or any contraindications to general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resection of Renal Cell Carcinoma and Stage IV Inferior Vena Cava Thrombus Without Thoracotomy: A Case Series and Literature Review.
Assessment of short-term outcomes of radical nephrectomy combined with IVC thrombectomy with a novel technique without thoracotomy: single center case series.
Read the detailed description
Assessment of the 30-day mortality and major complications as well as long-term oncological outcomes of three patients undergoing radical nephrectomy combined with inferior vena cava (IVC) thrombectomy with a novel technique without thoracotomy for renal cell carcinoma with IVC level IV thrombus. This is a retrospective case series carried out at Attikon University Hospital between January 2018 to March 2020.
- Conditions
- Renal Cell Carcinoma Stage III
- Being tested
- Radical nephrectomy with inferior vena cava thrombectomy without thoracotomy
- Keywords
- Renal cell carcinoma, Tumor thrombus, Inferior vena cava, level IV
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical nephrectomy with inferior vena cava thrombectomy without thoracotomyProcedure or surgery
The abdomen was accessed through a Makuuchi incision. After mobilization of the liver and assessment of the inferior vena cava infiltration (IVC), IVC was clamped below the level of the renal veins. In order to get access to the intrapericardial IVC, an incision was made through the tendon of the diaphragm and a clamp was placed first in the hepatoduodenal ligament (Pringle maneuver) and then in the endopericardial portion of the IVC, in that order. A longitudinal 3-4 cm incision was made incorporating the junction of IVC and right renal vein. After tumor removal thrombus was removed and a fine clamp was placed at the IVC just below the hepatocaval junction and immediate release of the clamping of the hepatoduodenal ligament. Total endopericardial clamp time was 4 minutes. Patients then underwent radical nephrectomy in a standard fashion with en bloc resection of the IVC thrombus.
| Study group | Role | What they receive |
|---|---|---|
| Transabdominal inferior vena cava thrombectomy | Patients undergoing radical nephrectomy and inferior vena cava thrombectomy transabdominal without thoracotomy Receives: Procedure: Radical nephrectomy with inferior vena cava thrombectomy without thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term mortality rate
Percentage of patients' postoperative deaths
Measured: 30 days
Secondary outcomes (2)
Short term major complications' rate
Incidence of Clavien/Dindo grade 3 or more postoperative complications
Measured: 30 days
Recurrence rate
Rate of local or systemic recurrence
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Jan 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Parasyris, Attikon Hospital
- Investigators
- Nikolaos Arkadopoulos, MD, PhD, Study director, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350047
- Sponsor's protocol ID
- Not appicable
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection of Renal Cell Carcinoma and Stage IV Inferior Vena Cava Thrombus Without Thoracotomy: A Case Series and Literature Review.
- ClinicalTrials.gov ID
- NCT04350047
- Acronym / sponsor ID
- Not appicable
- Conditions
- Renal Cell Carcinoma Stage III
- Keywords
- Renal cell carcinoma, Tumor thrombus, Inferior vena cava, level IV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assessment of short-term outcomes of radical nephrectomy combined with IVC thrombectomy with a novel technique without thoracotomy: single center case series.
Detailed description
Assessment of the 30-day mortality and major complications as well as long-term oncological outcomes of three patients undergoing radical nephrectomy combined with inferior vena cava (IVC) thrombectomy with a novel technique without thoracotomy for renal cell carcinoma with IVC level IV thrombus. This is a retrospective case series carried out at Attikon University Hospital between January 2018 to March 2020.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transabdominal inferior vena cava thrombectomy | – | Procedure: Radical nephrectomy with inferior vena cava thrombectomy without thoracotomyPatients undergoing radical nephrectomy and inferior vena cava thrombectomy transabdominal without thoracotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Among all patients with renal cell carcinoma operated in Attikon University Hospital, the ones with level IV tumor thrombus were included in the study.
Key inclusion criteria (2 listed)
- Adult patients
- Documented radiological and/or pathological diagnosis of renal cell carcinoma with level IV tumor thrombus
Key exclusion criteria (1 listed)
- American Anesthesia Association (ASA) Class V and/or any contraindications to general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical nephrectomy with inferior vena cava thrombectomy without thoracotomyThe abdomen was accessed through a Makuuchi incision. After mobilization of the liver and assessment of the inferior vena cava infiltration (IVC), IVC was clamped below the level of the renal veins. In order to get access to the intrapericardial IVC, an incision was made through the tendon of the diaphragm and a clamp was placed first in the hepatoduodenal ligament (Pringle maneuver) and then in the endopericardial portion of the IVC, in that order. A longitudinal 3-4 cm incision was made incorporating the junction of IVC and right renal vein. After tumor removal thrombus was removed and a fine clamp was placed at the IVC just below the hepatocaval junction and immediate release of the clamping of the hepatoduodenal ligament. Total endopericardial clamp time was 4 minutes. Patients then underwent radical nephrectomy in a standard fashion with en bloc resection of the IVC thrombus. | Procedure or surgery | Transabdominal inferior vena cava thrombectomy |
Primary outcome
Short term mortality rate
Time frame: 30 days
Percentage of patients' postoperative deaths
2 secondary outcomes
Short term major complications' rate
Time frame: 30 days
Recurrence rate
Time frame: 27 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolaos Arkadopoulos, MD, PhD study director
Attikon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma Stage III, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term mortality rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.