Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes
1 other identifier
interventional
120
0 countries
N/A
Brief Summary
The main purpose of this study is to assess the efficacy of precision preoperative embolization in decreasing operative blood loss, reducing surgical complications in pelvic tumor surgery. Furthermore the study aims at describing the vascularity in a series of pelvic tumors, and to correlate this with perioperative blood loss.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2022
CompletedFirst Posted
Study publicly available on registry
December 1, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedDecember 1, 2022
November 1, 2022
1.6 years
November 20, 2022
November 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Perioperative blood loss
Perioperative blood loss measured intraoperatively
Measured intraoperatively
Secondary Outcomes (4)
Adverse events related to angiography or embolization
Within 2 postoperative days
Adverse events related to surgery
Within 30 postoperative days
Vascularization grade of pelvic tumors
At the angiographic procedure prior to embolization performed 0-24 hours before surgery
postoperative blood loss
Within 2 postoperative days
Study Arms (2)
Precision preoperative embolization
EXPERIMENTAL60 patients with pelvic tumors will undergo arteriography and receive transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.
Control group
ACTIVE COMPARATOR60 patients with pelvic tumors will undergo arteriography and without transcatheter arterial embolization of pelvic tumors prior to surgery.
Interventions
Arteriography and transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.
Eligibility Criteria
You may qualify if:
- Primary or metastatic pelvic tumor
- Confirmed by contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) of the pelvic
- Planned surgical resection
You may not qualify if:
- Contrast medium allergy
- Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
XIN ZHI
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
November 20, 2022
First Posted
December 1, 2022
Study Start
February 1, 2023
Primary Completion
August 31, 2024
Study Completion
October 31, 2024
Last Updated
December 1, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share