xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05991856</url>
    </required_header>
    <id_info>
      <org_study_id>HuanXu</org_study_id>
      <nct_id>NCT05991856</nct_id>
    </id_info>
    <brief_title>Multifaceted Comparison of Ultrasound-guided Ablation and Laparoscopic Adrenalectomy for Aldosterone-producing Adenoma</brief_title>
    <official_title>Resident Doctor, Master Degree Candidate</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Third Affiliated Hospital, Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Third Affiliated Hospital, Sun Yat-Sen University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to retrospectively and prospectively analyze the efficacy and&#xD;
        safety of ultrasound-guided radiofrequency ablation and laparoscopic adrenalectomy in the&#xD;
        treatment of aldosterone-producing adenoma (APA). It is planned to retrospectively collect 30&#xD;
        patients with adrenal radiofrequency ablation for APA and 15 patients with age - and&#xD;
        sex-matched laparoscopic adrenalectomy for APA in our hospital from January 2020 to June&#xD;
        2024, and continue to follow up for 3 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary aldosteronism is the most common cause of secondary hypertension, and&#xD;
        aldosterone-producing adenoma (APA) is a benign adrenal tumor, accounting for about 35% of&#xD;
        primary aldosteronism. According to clinical guidelines, laparoscopic adrenalectomy is the&#xD;
        preferred treatment for unilateral APA. Recently, radiofrequency ablation, as a new&#xD;
        technique, has been applied to the treatment of APA. However, there are few relevant studies,&#xD;
        the sample size is generally small, and basically belong to retrospective studies, lacking&#xD;
        the comparison of long-term postoperative effects. Our hospital is the first to carry out&#xD;
        ultrasound-guided radiofrequency ablation of APA in Guangdong, China, with satisfactory&#xD;
        results. The purpose of this study is to retrospectively and prospectively analyze the&#xD;
        efficacy and safety of ultrasound guided radiofrequency elimination and laparoscopic&#xD;
        adrenalectomy in the treatment of APA. It is planned to retrospectively collect 30 patients&#xD;
        with adrenal radiofrequency ablation for APA and 15 patients with age - and sex-matched&#xD;
        laparoscopic adrenalectomy for APA in our hospital from January 2020 to June 2024, and&#xD;
        continue to follow up for 3 years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2020</start_date>
    <completion_date type="Anticipated">December 1, 2030</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Within 3 years</time_frame>
      <description>Effect of radiofrequency ablation and laparoscopic adrenalectomy on blood pressure levels in aldosterone-producing adenoma patients, including systolic and diastolic blood pressure(in millimeters of mercury, mmHg).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum potassium</measure>
      <time_frame>Within 3 years</time_frame>
      <description>Effect of radiofrequency ablation and laparoscopic adrenalectomy on serum potassium (mmol/L) levels in aldosterone-producing adenoma patient.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Aldosterone</measure>
      <time_frame>Within 3 years</time_frame>
      <description>The effects of radiofrequency ablation and laparoscopic adrenalectomy on aldosterone levels(ng/dl) in aldosterone-producing adenoma patients.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ARR</measure>
      <time_frame>Within 3 years</time_frame>
      <description>The effects of radiofrequency ablation and laparoscopic adrenalectomy on ARR (plasma aldosterone to renin activity ratio) in aldosterone-producing adenoma patients.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Complications</measure>
      <time_frame>Within 3 years</time_frame>
      <description>Intraoperative or postoperative complications of both types of surgery, including hypertensive crises, bleeding, and pancreatitis.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PASO</measure>
      <time_frame>Within 3 years</time_frame>
      <description>PASO(the Primary Aldosteronism Surgical Outcome) criteria were used to standardize the evaluation of outcomes of radiofrequency ablation and laparoscopic adrenalectomy, divided into clinical and biochemical outcomes, and the outcome grades were defined in terms of complete success, partial success, and unsuccessful.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Operation cost</measure>
      <time_frame>Within 3 years</time_frame>
      <description>Comparison of the operation costs of radiofrequency ablation and laparoscopic adrenalectomy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stays</measure>
      <time_frame>Within 3 years</time_frame>
      <description>Comparison of the hospital stays of radiofrequency ablation and laparoscopic adrenalectomy.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Aldosterone-producing Adenoma</condition>
    <condition>Radiofrequency Ablation</condition>
    <arm_group>
      <arm_group_label>radiofrequency ablation</arm_group_label>
      <description>Patients with aldosterone-producing adenoma undergoing ultrasound-guided radiofrequency ablation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>laparoscopic adrenalectomy</arm_group_label>
      <description>Patients with aldosterone-producing adenoma undergoing laparoscopic adrenalectomy</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>radiofrequency ablation</intervention_name>
      <description>The subjects is placed in a prone or lateral position under local anesthesia, and the electrodes are placed in the adrenal nodules under ultrasound guidance. A rapidly alternating radiofrequency current (300-500khz) generated around the electrode propagates through the adrenal nodules, causing resistance heating (Joule effect) and inducing cell death through coagulation necrosis. The choice of ablation time and frequency depends on the size, shape and location of the nodules within the adrenal gland.</description>
      <arm_group_label>radiofrequency ablation</arm_group_label>
      <other_name>RFA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>laparoscopic adrenalectomy</intervention_name>
      <description>The subjects was placed in a lateral position under general anesthesia. Using harmonic scalpel carefully separates the adrenal vessels and lates them. The adipose tissue around the adrenal gland is dissected carefully, the surrounding tissue is bluntly separated, and the adrenal gland is fully exposed and dissected. After adrenalectomy was completed, hemostasis was rechecked and specimens were removed.</description>
      <arm_group_label>laparoscopic adrenalectomy</arm_group_label>
      <other_name>LA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Hypotensive Drugs</intervention_name>
      <description>All subjects in the study selected appropriate antihypertensive drugs based on factors such as blood pressure level.</description>
      <arm_group_label>laparoscopic adrenalectomy</arm_group_label>
      <arm_group_label>radiofrequency ablation</arm_group_label>
      <other_name>HD</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          From January 2020 to January 2024, patients with APA were treated with adrenal RFA in our&#xD;
          hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. APA was confirmed with unilateral lesions;&#xD;
  &#xD;
            2. Benign tumor without adrenal metastasis and endovascular tumor embolus;&#xD;
  &#xD;
            3. Receive ultrasound-guided adrenal RFA treatment or laparoscopic resection, and sign&#xD;
               the informed consent for surgery;&#xD;
  &#xD;
            4. Age ≥ 18;&#xD;
  &#xD;
            5. Age ≥ 40 years old should meet the following criteria: blood potassium ≤3.5mmol/L;&#xD;
               PAC≥20ng/dL; PRC≤5μIU/mL; A unilateral adrenal nodule of 10mm or more was completely&#xD;
               normal on the opposite side.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Bilateral adrenal diseases;&#xD;
  &#xD;
            2. Multiple adrenal tumors;&#xD;
  &#xD;
            3. Other adrenal diseases, such as adrenal hyperplasia, Cushing's syndrome,&#xD;
               pheochromocytoma, etc.;&#xD;
  &#xD;
            4. Imaging suggests that the tumor may be difficult to reach;&#xD;
  &#xD;
            5. Imaging showed potential malignant adrenal tumor;&#xD;
  &#xD;
            6. Pregnant and/or planning a pregnancy;&#xD;
  &#xD;
            7. Refusing to participate in follow-up visits.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mengyin Cai, Dr</last_name>
      <role>Study Chair</role>
      <affiliation>Third Affiliated Hospital, Sun Yat-Sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xubin Yang, Dr</last_name>
      <phone>13763336436</phone>
      <email>yxbin@mail.sysu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Huan Xu, Dr</last_name>
      <phone>15218969361</phone>
      <email>huanhey@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Third Affiliated Hospital of Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Huan Xu, Dr.</last_name>
        <phone>15218969361</phone>
        <email>huanhey@126.com</email>
      </contact>
      <contact_backup>
        <last_name>Xubin Yang, Dr.</last_name>
        <phone>13763336436</phone>
        <email>yxbin@mail.sysu.edu.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.</citation>
      <PMID>26934393</PMID>
    </reference>
    <reference>
      <citation>Brown JM, Siddiqui M, Calhoun DA, Carey RM, Hopkins PN, Williams GH, Vaidya A. The Unrecognized Prevalence of Primary Aldosteronism: A Cross-sectional Study. Ann Intern Med. 2020 Jul 7;173(1):10-20. doi: 10.7326/M20-0065. Epub 2020 May 26.</citation>
      <PMID>32449886</PMID>
    </reference>
    <reference>
      <citation>Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.</citation>
      <PMID>28576687</PMID>
    </reference>
    <reference>
      <citation>Yang MH, Tyan YS, Huang YH, Wang SC, Chen SL. Comparison of radiofrequency ablation versus laparoscopic adrenalectomy for benign aldosterone-producing adenoma. Radiol Med. 2016 Oct;121(10):811-9. doi: 10.1007/s11547-016-0662-1. Epub 2016 Jun 14.</citation>
      <PMID>27300650</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Third Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
      <investigator_full_name>Xubin Yang</investigator_full_name>
      <investigator_title>Dr.</investigator_title>
    </responsible_party>
    <keyword>aldosterone-producing adenoma</keyword>
    <keyword>radiofrequency ablation</keyword>
    <keyword>laparoscopic adrenalectomy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Adenoma</mesh_term>
      <mesh_term>Adrenocortical Adenoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antihypertensive Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05991856
  org study id: HuanXu
  nct id: NCT05991856
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to retrospectively and prospectively analyze the efficacy and
        safety of ultrasound-guided radiofrequency ablation and laparoscopic adrenalectomy in the
        treatment of aldosterone-producing adenoma (APA). It is planned to retrospectively collect 30
        patients with adrenal radiofrequency ablation for APA and 15 patients with age - and
        sex-matched laparoscopic adrenalectomy for APA in our hospital from January 2020 to June
        2024, and continue to follow up for 3 years.
  Primary aldosteronism is the most common cause of secondary hypertension, and
        aldosterone-producing adenoma (APA) is a benign adrenal tumor, accounting for about 35% of
        primary aldosteronism. According to clinical guidelines, laparoscopic adrenalectomy is the
        preferred treatment for unilateral APA. Recently, radiofrequency ablation, as a new
        technique, has been applied to the treatment of APA. However, there are few relevant studies,
        the sample size is generally small, and basically belong to retrospective studies, lacking
        the comparison of long-term postoperative effects. Our hospital is the first to carry out
        ultrasound-guided radiofrequency ablation of APA in Guangdong, China, with satisfactory
        results. The purpose of this study is to retrospectively and prospectively analyze the
        efficacy and safety of ultrasound guided radiofrequency elimination and laparoscopic
        adrenalectomy in the treatment of APA. It is planned to retrospectively collect 30 patients
        with adrenal radiofrequency ablation for APA and 15 patients with age - and sex-matched
        laparoscopic adrenalectomy for APA in our hospital from January 2020 to June 2024, and
        continue to follow up for 3 years.
  observational model: Cohort
  time perspective: Other
  measure: Blood pressure
  time frame: Within 3 years
  description: Effect of radiofrequency ablation and laparoscopic adrenalectomy on blood pressure levels in aldosterone-producing adenoma patients, including systolic and diastolic blood pressure(in millimeters of mercury, mmHg).
  measure: Serum potassium
  time frame: Within 3 years
  description: Effect of radiofrequency ablation and laparoscopic adrenalectomy on serum potassium (mmol/L) levels in aldosterone-producing adenoma patient.
  measure: Aldosterone
  time frame: Within 3 years
  description: The effects of radiofrequency ablation and laparoscopic adrenalectomy on aldosterone levels(ng/dl) in aldosterone-producing adenoma patients.
  measure: ARR
  time frame: Within 3 years
  description: The effects of radiofrequency ablation and laparoscopic adrenalectomy on ARR (plasma aldosterone to renin activity ratio) in aldosterone-producing adenoma patients.
  measure: Complications
  time frame: Within 3 years
  description: Intraoperative or postoperative complications of both types of surgery, including hypertensive crises, bleeding, and pancreatitis.
  measure: PASO
  time frame: Within 3 years
  description: PASO(the Primary Aldosteronism Surgical Outcome) criteria were used to standardize the evaluation of outcomes of radiofrequency ablation and laparoscopic adrenalectomy, divided into clinical and biochemical outcomes, and the outcome grades were defined in terms of complete success, partial success, and unsuccessful.
  measure: Operation cost
  time frame: Within 3 years
  description: Comparison of the operation costs of radiofrequency ablation and laparoscopic adrenalectomy.
  measure: Length of hospital stays
  time frame: Within 3 years
  description: Comparison of the hospital stays of radiofrequency ablation and laparoscopic adrenalectomy.
  arm group label: radiofrequency ablation
  description: Patients with aldosterone-producing adenoma undergoing ultrasound-guided radiofrequency ablation
  arm group label: laparoscopic adrenalectomy
  description: Patients with aldosterone-producing adenoma undergoing laparoscopic adrenalectomy
  intervention type: Procedure
  intervention name: radiofrequency ablation
  description: The subjects is placed in a prone or lateral position under local anesthesia, and the electrodes are placed in the adrenal nodules under ultrasound guidance. A rapidly alternating radiofrequency current (300-500khz) generated around the electrode propagates through the adrenal nodules, causing resistance heating (Joule effect) and inducing cell death through coagulation necrosis. The choice of ablation time and frequency depends on the size, shape and location of the nodules within the adrenal gland.
  arm group label: radiofrequency ablation
  other name: RFA
  intervention type: Procedure
  intervention name: laparoscopic adrenalectomy
  description: The subjects was placed in a lateral position under general anesthesia. Using harmonic scalpel carefully separates the adrenal vessels and lates them. The adipose tissue around the adrenal gland is dissected carefully, the surrounding tissue is bluntly separated, and the adrenal gland is fully exposed and dissected. After adrenalectomy was completed, hemostasis was rechecked and specimens were removed.
  arm group label: laparoscopic adrenalectomy
  other name: LA
  intervention type: Drug
  intervention name: Hypotensive Drugs
  description: All subjects in the study selected appropriate antihypertensive drugs based on factors such as blood pressure level.
  arm group label: laparoscopic adrenalectomy
  arm group label: radiofrequency ablation
  other name: HD
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mengyin Cai, Dr
  role: Study Chair
  affiliation: Third Affiliated Hospital, Sun Yat-Sen University
  last name: Xubin Yang, Dr
  phone: 13763336436
  email: yxbin@mail.sysu.edu.cn
  last name: Huan Xu, Dr
  phone: 15218969361
  email: huanhey@126.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  citation: Funder JW, Carey RM, Mantero F, Murad MH, Reincke M, Shibata H, Stowasser M, Young WF Jr. The Management of Primary Aldosteronism: Case Detection, Diagnosis, and Treatment: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016 May;101(5):1889-916. doi: 10.1210/jc.2015-4061. Epub 2016 Mar 2.
  PMID: 26934393
  citation: Brown JM, Siddiqui M, Calhoun DA, Carey RM, Hopkins PN, Williams GH, Vaidya A. The Unrecognized Prevalence of Primary Aldosteronism: A Cross-sectional Study. Ann Intern Med. 2020 Jul 7;173(1):10-20. doi: 10.7326/M20-0065. Epub 2020 May 26.
  PMID: 32449886
  citation: Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.
  PMID: 28576687
  citation: Yang MH, Tyan YS, Huang YH, Wang SC, Chen SL. Comparison of radiofrequency ablation versus laparoscopic adrenalectomy for benign aldosterone-producing adenoma. Radiol Med. 2016 Oct;121(10):811-9. doi: 10.1007/s11547-016-0662-1. Epub 2016 Jun 14.
  PMID: 27300650
  responsible party type: Principal Investigator
  investigator affiliation: Third Affiliated Hospital, Sun Yat-Sen University
  investigator full name: Xubin Yang
  investigator title: Dr.
  mesh term: Adenoma
  mesh term: Adrenocortical Adenoma
  mesh term: Antihypertensive Agents
  sharing ipd: No