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CTRI Number  CTRI/2017/11/010501 [Registered on: 15/11/2017] Trial Registered Retrospectively
Last Modified On: 14/11/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing catheter mediated uterine vessel occlusion with uterine removal by surgery for treatment of uterine fibroids 
Scientific Title of Study   A Pilot study comparing efficacy of Uterine artery embolisation vs hysterectomy in patients with symptomatic uterine fibroids. 
Trial Acronym  UAE  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Shivanand R Gamanagatti 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no.81-B, Department of Radiodiagnosis, near RAK OPD All India Institute of medical sciences, Ansari Nagar, New Delhi-29
Room no.52, department of radiology, JPN Apex trauma centre, New Delhi
South
DELHI
110029
India 
Phone  01126594567  
Fax    
Email  Shiv223@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Shivanand R Gamanagatti 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no.81-B, Department of Radiodiagnosis, near RAK OPD All India Institute of medical sciences, Ansari Nagar, New Delhi-29
Room no.52, department of radiology, JPN Apex trauma centre, New Delhi
South
DELHI
110029
India 
Phone  01126594567  
Fax    
Email  Shiv223@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Shivanand R Gamanagatti 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no.81-B, Department of Radiodiagnosis, near RAK OPD All India Institute of medical sciences, Ansari Nagar, New Delhi-29
Room no.52, department of radiology, JPN Apex trauma centre, New Delhi
South
DELHI
110029
India 
Phone  01126594567  
Fax    
Email  Shiv223@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Scences Ansari Nagar, New Delhi 
 
Primary Sponsor  
Name  Department of Radiodiagnosis 
Address  Department of Radiodiagnosis, Near RAK OPD, All India Institute of Medical Sciences 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Shivanand R Gamanagatti  All India Institute of Medical Sciences  Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi.
South
DELHI 
01126594567

shiv223@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients presenting with menorrhagia(PBAC score 100) and pelvic pain, pressure symptoms attributable to uterine fibroids.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hysterectomy  Patients who have completed their family and have severe symptoms attributable to uterine fibroids not controlled on medical management will undergo hysterectomy if they dont want to preserve their uterus. 
Intervention  Uterine artery embolisation  Endovascular catheter uterine artery embolisation will be done using particulate material like poly vinyl alcohol(PVA) to reduce the vascular supply and cause infarction of uterine fibroids to control symptoms. It will be done in patients who have completed their family and want to preserve their uterus. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Menstruating women with symptomatic uterine fibroids who have completed their family
Uterus size≤ 24 weeks on bimanual examination. Ultrasonography suggestive ofat least one uterine myoma of ≥ 3 cm diameter in size
 
 
ExclusionCriteria 
Details  1.Uterine size > 24 weeks on clinical examination.
2. Any single myoma size > 12 cm on ultrasonography. Patients can also be taken up for UAE post trial of GnRH agonists if the fibroid 3. size at presentation is more than 12 cm at initial presentation
4.Active pelvic infection or pregnancy
5.Suspected or known case of gynecological cancer/atypical endometrial hyperplasia.
6. Known case of uncontrolled coagulation disorder, renal insufficiency, severe contrast allergy
7. Large uterine polyp (>2 cm), Submucosal fibroid (class 0 & 1 under myoma sub-classification system)
8. Large subserosal fibroids with narrow stalk
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Fibroid size as assessed by USG or MRI
Uterine fibroid Quality of life assessment score
 
6 months after treatment
 
 
Secondary Outcome  
Outcome  TimePoints 
Relief of symptoms like pain, pressure symptoms and menorrhagia
Percentage necrosis of myoma on post embolization MRI 
Relief of symptoms in 6 months
Percentage necrosis on post embolisation MRI in 6 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/01/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Project will be started in next 15 days. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Uterine myomas are benign uterine neoplasms that arise from the smooth muscle of uterus. They constitute the most common benign gynecological tumors affecting 20-50% of women of reproductive age group, thirty percent of these presenting with menstrual abnormality and menorrhagia being most common (1). Other presenting symptoms include pelvic pain (34%), infertility (27%) and pelvic mass (9%) (1). Occasionally they are associated with bladder and bowel pressure symptoms.

              Uterine fibroids may occur singly but most often are multiple and vary in size from an unnoticeable few millimetres to over 20 cm in diameter, significantly enlarging the abdominal cavity. They are named according to their location. Intramural fibroids lie wholly within the uterine walls, submucosal fibroids project into the uterine cavity and subserosal fibroids project from the outer surface of the uterus. They may also be pedunculated, where they are attached to the uterine wall by a stalk-like structure.

Most of the myomas are asymptomatic and does not require treatment until symptomatic or causing infertility. The management of symptomatic fibroids has traditionally been surgical; however, alternative pharmacological treatments have been proposed to control symptoms. The choice of appropriate therapeutic approach depends on several factors including: age, parity, childbearing aspirations, extent and severity of symptoms, size, number, location of myomas, proximity to menopause.

Ravina et al (2) first reported transcatheter embolization of the uterine arteries for treatment of uterine leiomyomata in 1995. The safety and efficacy of the procedure have been extensively studied, and UFE is now accepted as a treatment option for fibroids by the American Congress of Obstetricians and Gynecologists (3). UFE has been shown to reduce pain, bulk symptoms (pressure and abdominal wall distortion), and menorrhagia in most cases (4). Although hysterectomy has long been considered the definitive treatment for symptomatic fibroids and remains the most common intervention for fibroids, there is growing interest in less invasive therapies and treatments that avoid removal of the uterus, including medical management, abdominal or laparoscopic myomectomy, endometrial ablation, focused US, and UFE (5). Uterine embolization has emerged as one of the most important of these uterine-sparing options.

Uterine artery embolization (UAE) involves complete occlusion of either one or both uterine arteries with particulate emboli to cause ischaemic necrosis of the uterine fibroids. The closure of the arteries is considered permanent, thereby blocking blood supply to the fibroid but without any permanent adverse effect on the otherwise normal uterus.

Since there are studies that Uterine artery embolization may cause a reduction in the reproductive potential of women as compared to a laparoscopic myomectomy and also it might predispose nulliparous women to placental abnormalities, we plan to use it only for women who have completed their family and seek treatment for bleeding, pain and pressure symptoms.

Given its minimally invasive nature, established favorable cost profile, and associated rapid recovery and return to work, UAE should be considered a front-line therapy for leiomyomata and should therefore be presented to all patients as an option for symptomatic leiomyomas. With this background, we plan to study the therapeutic effect of uterine artery embolization for treating symptomatic fibroids.

 
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