Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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，which including poor wound healing，nerve injury，and pelvic organs dysfunction. Furthermore the study aims at describing the vascularity in a series of pelvic tumors,which contains four grade：poor，moderate，rich and abundant and to correlate this with perioperative blood loss.

Official Title
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Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

Conditions
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Embolization, Pelvic Tumor

Intervention / Treatment
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* Procedure: Arteriography and precision preoperative embolization
* Procedure: Arteriography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary or metastatic pelvic tumor Confirmed by contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) of the pelvic Planned surgical resection Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Precision preoperative embolization<br>60 patients with pelvic tumors will undergo arteriography and receive transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery. | Procedure: Arteriography and precision preoperative embolization<br>* Arteriography and transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.<br>* Other names: Selective arterial embolization;|
| Active Comparator: Control group<br>60 patients with pelvic tumors will undergo arteriography and without transcatheter arterial embolization of pelvic tumors prior to surgery. | Procedure: Arteriography<br>* Arteriography of pelvic tumors 0-24 hours prior to surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative blood loss | Perioperative blood loss measured intraoperatively | Measured intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events related to angiography or embolization | Including symptoms of nerve compression, pelvic organ ischemia injury | Within 2 postoperative days | 
| Adverse events related to surgery | including poor wound healing，nerve injury，pelvic organ dysfunction | Within 30 postoperative days | 
| Vascularization grade of pelvic tumors | it contains four grades：poor、moderate、rich、abundant | At the angiographic procedure prior to embolization performed 0-24 hours before surgery | 
| postoperative blood loss | blood loss measured through the drainage within 2 postoperative days | Within 2 postoperative days |