Comparing Efficacy of Microwave vs Embolization Treatment for Adenomyosis

Learn more about:
Related Clinical Trial
Radiofrequency Ablation of Adenomyosis Determination of the Incidence of Endometriosis and or Adenomyosis in Patients Diagnosed With Polycystic Ovary Syndrome, or the Incidence of Polycystic Ovary Syndrome in Patients Diagnosed With Endometriosis and or Adenomyosis The Effect of Adenomoyosis on Pregnancy Outcomes Observational Study of Patients Suffering From Endometriosis and Adenomyosis Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis Quality of Life After Hysterectomy (AdenoQOL) Low Molecular Weight Heparin on the Adenomyosis Patients’IVF-ET Outcome Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI Clinical and Molecular Study of Endometriosis and Adenomyosis Surgical Success After Laparoscopic vs Abdominal Hysterectomy Electronic Catheter Stethoscope Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? Single-port Access Laparoscopic-assisted Vaginal Hysterectomy Uterine Artery Embolization for Symptomatic Fibroids Oxytocin in MRI-HIFU To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy Effect of Addition of Steroids on Duration of Analgesia Paracervical Block in Laparoscopic Hysterectomy Use of Dexamethasone in Uterine Artery Embolization Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU) Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS) Dienogest for Treatment of Adenomyotic Uteri Health-Related QoL Among Women Receiving Hysterectomy in NTUH Development and Validation of EHP-30 (Hong Kong Chinese Version) for Patients With Endometriosis and Adenomyosis Adenomyosis and Ulipristal Acetate Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis LNG-IUS for Treatment of Dysmenorrhea Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis Adenomyosis: Genomic Mechanisms and Biological Response What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography Comparing Efficacy of Microwave vs Embolization Treatment for Adenomyosis Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis A Prospective Study of Diagnostic Accuracy of Ultrasound Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis A Multi-omics Study of Adenomyosis Norwegian Adenomyosis Study II: Gene Expression Profiling of Adenomyosis Levonorgestrel Intrauterine System and Adenomyosis Validation of the Adenomyosis Calculator Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer. New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis Norwegian Adenomyosis Study III: Peristalsis Histopathological Diagnosis of Adenomyosis Norwegian Adenomyosis Study I Vaginal Bromocriptine for Treatment of Adenomyosis Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

Brief Title

Comparing Efficacy of Microwave vs Embolization Treatment for Adenomyosis

Official Title

Single Blinded Randomized Controlled Study of Symptom Improvement After Uterine Artery Embolization (UAE) Versus Ultrasound Guided Percutaneous/Transvaginal Microwave Ablation, Evaluated by Validated Questionnaires

Brief Summary

      Single blinded randomized controlled study of symptom improvement after uterine artery
      embolization (UAE) versus ultrasound guided percutaneous/transvaginal microwave ablation,
      evaluated by validated questionnaires.

      Adenomyosis is a benign condition causing pain and bleeding disorders in many women.
      Hysterectomy has historically been the golden standard for treatment as well as
      (postoperatively) diagnosis of the disease. In accordance with refined diagnostic tools such
      as ultrasound and/or MRI, minimally invasive treatments for adenomyosis are being explored.

      We plan to compare two minimally invasive techniques: embolization of the uterine artery (a
      commonly used procedure) and microwave ablation of adenomyotic tissue (previously only in
      clinical use in China).
    

Detailed Description

      Single blinded randomized controlled study of symptom improvement after uterine artery
      embolization (UAE) versus ultrasound guided percutaneous/transvaginal microwave ablation,
      evaluated by validated questionnaires.

      Background

      Adenomyosis is a benign gynecological condition, where endometrial glands and stroma invades
      the myometrial walls of the uterus. The disease is thought to be estrogen-dependent, but the
      etiology, as well as the prevalence, is currently unknown. Known risk-factors are previous
      uterine surgery and parity, although the disease has been found also in nulligravida with no
      previous uterine trauma. Adenomyosis can cause severe dysmenorrhea, menorrhagia, chronic
      pelvic pain and infertility. Historically diagnosis has been made post hysterectomy by
      pathologists, however with transvaginal ultrasound (TVUS) as well as MRI the condition is now
      possible to identify with non-invasive methods.

      Hysterectomy has previously been seen as the golden standard treatment for adenomyosis, but
      may cause long-term side effects such as genitovaginal prolapse. It also carries a
      substantial risk of short term complications such as infections and organ damage.

      Symptomatic treatment such as the levonogestrel intrauterine system (LNG-IUS) can be
      effective, however there is a risk of expulsion and irregular bleedings.

      In recent years, increasing attention has been paid to the study of minimally invasive or
      non-invasive therapies with uterine preservation such as uterine arterial embolization (UAE),
      radiofrequency (RF), microwave treatment and high intensity focused ultrasound (HIFU). A
      randomized controlled study is ongoing, comparing UAE and hysterectomy. RF ablation often
      requires the aid of a laparoscopic procedure, which is invasive. HIFU is currently only
      described in small cohorts and case-reports. Ultrasound or computer tomography guided
      percutaneous microwave thermal ablation is minimally invasive, has low time requirements, is
      easy to perform, and has been broadly used for the treatment of solid tumours in organs other
      than the uterus with favourable effects.

      Microwave ablation of adenomyosis has been performed in China. The effect and acceptability
      has been high. The research team in this study has been to China to study the treatment. We
      have visited the clinic and studied the procedure as well as talked to patients pre- and post
      operatively . The equipment at Danderyd Hospital has the same output effects as the equipment
      in China. Danderyd Hospital has approved the method for use in uterine myomas. However, no
      randomized comparative study of other minimally invasive methods has been performed.

      This study aims to compare the effectiveness, feasibility and acceptability of percutaneous
      CT- or ultrasound guided microwave ablation and uterine artery embolization for the treatment
      of adenomyosis in a randomized single blind study.

      Recruitment and Randomization

      Women fulfilling inclusion criteria and without exclusion criteria will be identified at the
      outpatient clinic of Danderyd Hospital. Advertisement may be placed in local newspapers or on
      social media (Facebook and Instagram) and relevant webpages or in gynecological clinics.

      Women will be randomized after having been informed orally and in written and after having
      signed informed consent and after fulfilling inclusion and exclusion criteria after
      MRI-examination. Randomization will be in random permuted blocks of 6 at a ratio of 1:1. The
      randomization will be according to a computer generated randomization sequence. After
      patients have signed informed consent and fulfill inclusion without exclusion criteria after
      the initial magnetic resonance imaging they will be allocated to an intervention by
      consecutive opening of sealed opaque envelopes containing the randomization code.

      Blinding

      Patients and investigators will not be blinded. The MRI will be performed and evaluated by a
      blinded radiologist.

      Method

      Pre randomization evaluation After having signed informed consent but before randomization
      patients will undergo MRI of the uterus. Patients with endometriosis or a clinically
      significant presence of uterine fibroids (myomas>3cm) will be excluded.

      All women included in the study after MRI examination will fill in a PBAC evaluation during
      the menses preceding treatment. Women will fill a VNRS for maximal pain during 1 month prior
      to treatment. In addition a full blood panel will be evaluated.

      As for uterine artery embolization no pathologist report will be performed before any
      treatment.

      Microwave ablation Microwave ablation will be performed percutaneously or vaginally using a
      Covidien Emprint microwave ablation system with a 30-80 Watts effect in 14-16 gauge needle
      with a ceramic tip using computer tomography with fusion technique or ultrasound for
      adenomyosis imaging and needle guidance. After identification of the needle path with CT or
      peroperative ultrasound a small skin incision using a scalpel will made for the needle entry
      in the case of percutaneous treatment. No incision will be made if treatment is given
      vaginally. When needed to optimize the needle path in order not to damage adjacent organs,
      artificial ascites (approx 500mL Ringer-acetate) will be created using a thin syringe through
      the abdominal wall. The ablation zone of a 70W needle is estimated to be 4x3x3 cm after 300s
      or 5x4x4 cm after 600s. Patients will be given intravenous anesthesia with spontaneous
      breathing or general anesthesia during treatment to minimize movement during ablation.

      Uterine artery embolization Embolization will be performed in conscious women with an
      epidural catheter or patient controlled analgesia for pain relief. A catheter will be
      inserted in the femoral artery to access the uterine artery during x-ray monitoring and
      during administration of contrast to visualize the adenomyotic tissue and its supporting
      arterial supply. When the supporting arterial branch has been identified polyvinyl alcohol
      particles are released into the bloodstream. These particles cause a thrombosis in the
      vessel.

      Evaluation post treatment Women will estimate VNRS maximum postoperative pain day of surgery
      and the following 7 days. In addition, they will note how many days passed before all pain
      subsided, use of pain medication will be noted and period until resuming normal daily
      activities. The period of hospitalization will be noted.

      Menstrual blood loss (PBAC) will be noted the first menstruation, menstruation number 3 and 5
      post treatment. PBAC is a validated instrument for menstrual blood loss quantification.
      UFS-QOL is a validated instrument for women with uterine fibroids, but is commonly used also
      in trials regarding adenomyosis, and will be evaluated 6 months post treatment.

      Follow-up visits will be after 1-2 menstruation at approximately 2 months and at 6 months
      post-treatment.

      At follow up visit 2 months (+/-2 weeks) and 6 months (+/-2 weeks) post treatment
      acceptability will be assessed as overall satisfaction of treatment on a scale from 1-7 and
      if the woman would recommend the treatment to a friend. At the follow up visit at 6 months
      hemoglobin, cancer antigen 125 (CA-125), Anti-Müllerian Hormone (AMH), and prolactine (PRL)
      will be measured. AMH estimates the effect of the treatment on the ovarian reserve. CA-125
      and PRL have been used to evaluate pathophysiological changes in adenomyosis. These will be
      compared to levels taken on the day of the operative procedure. A uterine biopsy will also be
      performed.

      A new MRI scan will be performed 6 months post treatment (+/-21 days). Women will then be
      asked to participate in a long-term follow up (>12 months) with evaluation of recurrence of
      symptoms, with clinical controls (gynecological exams and TVUS) and using PBAC and UFS-QOL
      yearly until retraction of consent.

      Clinical significance

      Adenomyosis is a benign condition but have a significant impact on the lives of women, and
      the condition is not well studied. Reports have suggested adenomyosis in approximately 40% of
      patients undergoing hysterectomy. Women with adenomyosis are much more likely to report on
      symptoms as dysmenhorrea, heavy menstrual bleeding, infertility and chronic pelvic pain. As
      hysterectomy is a highly invasive procedure with costs for women in terms of absence from
      work and short and long term complications, finding new minimally invasive and
      uterine-sparing treatments would be beneficial for affected women.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

1. Symptom improvement 6 months post treatment (+/-21 days) compared to pre treatment, evaluated by UFS-QOL

Secondary Outcome

 Reduction of adenomyosis by imaging

Condition

Adenomyosis

Intervention

Microwave treatment via needle antenna

Study Arms / Comparison Groups

 Microwave treatment
Description:  Percutaneous or vaginal application of microwave antenna with microwave treatment for adenomyosis

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

20

Start Date

February 2020

Completion Date

February 2022

Primary Completion Date

August 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy women aged 30-55 with symptomatic adenomyosis

          -  Premenopausal

          -  Adenomyosis diagnosted by TVUS and MRI

          -  Willing to comply with protocol

        Exclusion Criteria:

          -  Current or future childwish

          -  Body Mass Index >35

          -  Treatment with anticoagulant/bleeding disorder

          -  Visible myomas >3cm or visible endometriosis on UL/MRI

          -  Contraindication for UAE or general anesthesia
      

Gender

Female

Ages

30 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Helena Kopp Kallner, MD PhD, +46812358927, [email protected]



Administrative Informations


NCT ID

NCT04209127

Organization ID

ADENOMIC1


Responsible Party

Principal Investigator

Study Sponsor

Karolinska Institutet


Study Sponsor

Helena Kopp Kallner, MD PhD, Principal Investigator, Karolinska Institutet


Verification Date

December 2019