HypertensionNCT06829134
Clinical Analysis of the Antihypertensive Effect of Laparoscopic Peripheral Nerve Blockade of the Renal Artery in Patients With Retroperitoneal Disease and Hypertension
A study testing laparoscopic renal artery perivascular nerve blockade and surgery related to the primary disease in people with Hypertension and Retroperitoneal Disease, run by Ruijin Hospital at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety of laparoscopic renal artery nerve blockade surgery in patients with retroperitoneal diseases complicated by hypertension. The study aims to address the following two questions: 1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Retroperitoneal Disease
- What is being tested?
- laparoscopic renal artery perivascular nerve blockade and surgery related to the primary disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal artery diameter ≥ 4 mm, length ≥ 20 mm.
- Age between 18 and 75 years, male or female.
- Scheduled to undergo laparoscopic surgery: The patient has a clear diagnosis of adrenal tumor, early-stage renal malignancy, renal cyst, etc., and meets the surgical indications recommended by guidelines or relative surgical indications but has a strong willingness for surgery. The patient requires surgery (such as laparoscopic partial adrenalectomy, laparoscopic unilateral adrenalectomy, laparoscopic partial nephrectomy, laparoscopic renal cyst decapitation, etc.) and meets the surgical conditions.
- A clear diagnosis of hypertension: Either the patient has never used antihypertensive medications, with in-office blood pressure ≥ 140/90 mmHg and < 180/110 mmHg, or 24-hour daytime ambulatory blood pressure ≥ 135/85 mmHg and < 170/105 mmHg. Alternatively, the patient has been diagnosed with hypertension and has been taking antihypertensive medications for at least 4 weeks.
- Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73 m².
- The patient is willing and able to comply with the study protocol, provide written informed consent, and agrees to participate in follow-up assessments.
Who cannot join
- Renal artery abnormalities: Hemodynamic or anatomical stenosis (≥50%) of one renal artery; post-renal artery balloon angioplasty or stent placement;
- Cardiovascular risk factors: Including myocardial infarction, unstable angina, or cerebrovascular events within the past 6 months; extensive atherosclerosis with intravascular thrombosis or unstable plaques; and significant hemodynamic changes due to heart valve disease;
- History of similar surgeries: Such as previous renal sympathetic nerve ablation via catheter;
- Other severe organic diseases;
- Participation in other clinical studies;
- Investigator's judgment: The investigator determines that, based on medical expertise, the patient is unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital
Shanghai
Xu, 13901734568, xdf12036@rjh.com.cn
About this study
The primary objective of this study is to evaluate the efficacy and safety of laparoscopic renal artery nerve blockade surgery in patients with retroperitoneal diseases complicated by hypertension.
The study aims to address the following two questions:
Read more
- Can laparoscopic renal artery perivascular nerve blockade reduce postoperative blood pressure and decrease the dependence on antihypertensive medications in patients with retroperitoneal diseases and hypertension?
- What is the safety profile of the procedure, and does it lead to any complications?
The researchers will randomly assign patients to the experimental group and the control group. The experimental group will undergo surgery related to the primary disease in addition to laparoscopic renal artery perivascular nerve blockade, while the control group will only receive surgery related to the primary disease. This design allows for a comparison of the effects of renal artery perivascular nerve blockade on postoperative blood pressure.
Participants will:
- Patients will undergo either surgery related to the primary disease combined with renal artery perivascular nerve blockade, or surgery related to the primary disease alone.
- For the three months following surgery, the antihypertensive medication regimen will remain unchanged from the preoperative plan. At the end of the three-month period, patients will visit the hospital for 24-hour ambulatory blood pressure monitoring.
- Conditions
- Hypertension, Retroperitoneal Disease
- Being tested
- laparoscopic renal artery perivascular nerve blockade, surgery related to the primary disease
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic renal artery perivascular nerve blockadeProcedure or surgery
- When only the main renal artery is present: The complete dissection of the renal artery should be performed in the distal 2/3 portion, close to the renal hilum. The connective tissue and nerve tissue within a 1 cm radius from the center of the renal artery lumen must be completely separated (using instruments such as an ultrasonic scalpel or monopolar hook, etc.). The length of the dissected renal artery should be at least 0.5 cm, forming a dissection ring.
- When accessory renal arteries are present: In addition to the main renal artery meeting the aforementioned standards, the accessory renal arteries must also be dissected. The radius of the dissection ring should be 0.7 cm, with a length ranging from 0.3 to 0.5 cm.
- When renal polar arteries are present: Dissection may be performed appropriately based on the surgical conditions.
- The prerequisite is to ensure the safety of the surgery, specifically the safe resection of the primary lesion.
surgery related to the primary diseaseProcedure or surgery
The surgeries related to the primary disease include laparoscopic partial nephrectomy, laparoscopic adrenalectomy, and other similar procedures.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group will undergo surgery related to the primary disease in addition to laparoscopic renal artery perivascular nerve blockade. Receives: Procedure: laparoscopic renal artery perivascular nerve blockade; Procedure: surgery related to the primary disease |
| control group | Sham comparator | The control group will only receive surgery related to the primary disease. Such as laparoscopic partial nephrectomy, laparoscopic adrenalectomy etc. Receives: Procedure: surgery related to the primary disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
The blood pressure values at 3 months post-surgery.
The average systolic blood pressure (ASBP) during 24-hour ambulatory blood pressure monitoring at 3 months post-surgery.
Measured: 3 months
Secondary outcomes (4)
The blood pressure values at other different time points.
The 24-hour ambulatory blood pressure data at 1 month, 6 months, 12 months, and 24 months post-surgery, as well as the dynamic blood pressure data at 3 months post-surgery, excluding the primary outcomes.
Measured: 1 month, 3 months，6 months, 12 months, and 24 months
antihypertensive medications
The use of antihypertensive medications at 1 month, 3 months, 6 months, 12 months, and 24 months post-surgery.
Measured: 1 month, 3 months，6 months, 12 months, and 24 months
Health status.
At each time point, health status will be assessed and quantified using the EuroQoL Five-Dimensions Three-Level (EQ-5D-3L) standardized scale.
Measured: 1 month, 3 months，6 months, 12 months, and 24 months
Pain score
At each time point, Pain scores will be assessed and quantified using the Visual Analog Scale (VAS).
Measured: 1 month, 3 months，6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829134
- Sponsor's protocol ID
- 2024-489
- Status last verified
- Nov 2024
- First submitted
- 22 Jan 2025
- Last updated
- 17 Feb 2025
- Results posted
- 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 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Analysis of the Antihypertensive Effect of Laparoscopic Peripheral Nerve Blockade of the Renal Artery in Patients With Retroperitoneal Disease and Hypertension
- ClinicalTrials.gov ID
- NCT06829134
- Acronym / sponsor ID
- 2024-489
- Conditions
- Hypertension, Retroperitoneal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 17 Feb 2025 (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.
The primary objective of this study is to evaluate the efficacy and safety of laparoscopic renal artery nerve blockade surgery in patients with retroperitoneal diseases complicated by hypertension.
The study aims to address the following two questions:
- Can laparoscopic renal artery perivascular nerve blockade reduce postoperative blood pressure and decrease the dependence on antihypertensive medications in patients with retroperitoneal diseases and hypertension?
- What is the safety profile of the procedure, and does it lead to any complications?
The researchers will randomly assign patients to the experimental group and the control group. The experimental group will undergo surgery related to the primary disease in addition to laparoscopic renal artery perivascular nerve blockade, while the control group will only receive surgery related to the primary disease. This design allows for a comparison of the effects of renal artery perivascular nerve blockade on postoperative blood pressure.
Participants will:
- Patients will undergo either surgery related to the primary disease combined with renal artery perivascular nerve blockade, or surgery related to the primary disease alone.
- For the three months following surgery, the antihypertensive medication regimen will remain unchanged from the preoperative plan. At the end of the three-month period, patients will visit the hospital for 24-hour ambulatory blood pressure monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: laparoscopic renal artery perivascular nerve blockade, Procedure: surgery related to the primary diseaseThe experimental group will undergo surgery related to the primary disease in addition to laparoscopic renal artery perivascular nerve blockade. |
| control group | Sham comparator | Procedure: surgery related to the primary diseaseThe control group will only receive surgery related to the primary disease. Such as laparoscopic partial nephrectomy, laparoscopic adrenalectomy etc. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Renal artery diameter ≥ 4 mm, length ≥ 20 mm.
- Age between 18 and 75 years, male or female.
- Scheduled to undergo laparoscopic surgery: The patient has a clear diagnosis of adrenal tumor, early-stage renal malignancy, renal cyst, etc., and meets the surgical indications recommended by guidelines or relative surgical indications but has a strong willingness for surgery. The patient requires surgery (such as laparoscopic partial adrenalectomy, laparoscopic unilateral adrenalectomy, laparoscopic partial nephrectomy, laparoscopic renal cyst decapitation, etc.) and meets the surgical conditions.
- A clear diagnosis of hypertension: Either the patient has never used antihypertensive medications, with in-office blood pressure ≥ 140/90 mmHg and < 180/110 mmHg, or 24-hour daytime ambulatory blood pressure ≥ 135/85 mmHg and < 170/105 mmHg. Alternatively, the patient has been diagnosed with hypertension and has been taking antihypertensive medications for at least 4 weeks.
- Estimated glomerular filtration rate (eGFR) ≥ 45 ml/min/1.73 m².
Key exclusion criteria (6 listed)
- Renal artery abnormalities: Hemodynamic or anatomical stenosis (≥50%) of one renal artery; post-renal artery balloon angioplasty or stent placement;
- Cardiovascular risk factors: Including myocardial infarction, unstable angina, or cerebrovascular events within the past 6 months; extensive atherosclerosis with intravascular thrombosis or unstable plaques; and significant hemodynamic changes due to heart valve disease;
- History of similar surgeries: Such as previous renal sympathetic nerve ablation via catheter;
- Other severe organic diseases;
- Participation in other clinical studies;
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 |
|---|---|---|
| laparoscopic renal artery perivascular nerve blockade1. When only the main renal artery is present: The complete dissection of the renal artery should be performed in the distal 2/3 portion, close to the renal hilum. The connective tissue and nerve tissue within a 1 cm radius from the center of the renal artery lumen must be completely separated (using instruments such as an ultrasonic scalpel or monopolar hook, etc.). The length of the dissected renal artery should be at least 0.5 cm, forming a dissection ring. 2. When accessory renal arteries are present: In addition to the main renal artery meeting the aforementioned standards, the accessory renal arteries must also be dissected. The radius of the dissection ring should be 0.7 cm, with a length ranging from 0.3 to 0.5 cm. 3. When renal polar arteries are present: Dissection may be performed appropriately based on the surgical conditions. 4. The prerequisite is to ensure the safety of the surgery, specifically the safe resection of the primary lesion. | Procedure or surgery | experimental group |
| surgery related to the primary diseaseThe surgeries related to the primary disease include laparoscopic partial nephrectomy, laparoscopic adrenalectomy, and other similar procedures. | Procedure or surgery | control group, experimental group |
Primary outcome
The blood pressure values at 3 months post-surgery.
Time frame: 3 months
The average systolic blood pressure (ASBP) during 24-hour ambulatory blood pressure monitoring at 3 months post-surgery.
4 secondary outcomes
The blood pressure values at other different time points.
Time frame: 1 month, 3 months，6 months, 12 months, and 24 months
antihypertensive medications
Time frame: 1 month, 3 months，6 months, 12 months, and 24 months
Health status.
Time frame: 1 month, 3 months，6 months, 12 months, and 24 months
Pain score
Time frame: 1 month, 3 months，6 months, 12 months, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic renal artery perivascular nerve blockade and surgery related to the primary disease in people with Hypertension and Retroperitoneal Disease, run by Ruijin Hospital at 1 site in China.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Feb 2025. 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 China. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The blood pressure values at 3 months post-surgery. (time frame: 3 months). 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 17 Feb 2025.