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Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

Primary Purpose

Embolization, Pelvic Tumor

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arteriography and precision preoperative embolization
Arteriography
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Embolization

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Precision preoperative embolization

    Control group

    Arm Description

    60 patients with pelvic tumors will undergo arteriography and receive transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.

    60 patients with pelvic tumors will undergo arteriography and without transcatheter arterial embolization of pelvic tumors prior to surgery.

    Outcomes

    Primary Outcome Measures

    Perioperative blood loss
    Perioperative blood loss measured intraoperatively

    Secondary Outcome Measures

    Adverse events related to angiography or embolization
    Including symptoms of nerve compression, pelvic organ ischemia injury
    Adverse events related to surgery
    including poor wound healing，nerve injury，pelvic organ dysfunction
    Vascularization grade of pelvic tumors
    it contains four grades：poor、moderate、rich、abundant
    postoperative blood loss
    blood loss measured through the drainage within 2 postoperative days

    Full Information

    First Posted
    November 20, 2022
    Last Updated
    November 30, 2022
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05633134
    Brief Title
    Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes
    Official Title
    Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    August 31, 2024 (Anticipated)
    Study Completion Date
    October 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Embolization, Pelvic Tumor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Precision preoperative embolization
    Arm Type
    Experimental
    Arm Description
    60 patients with pelvic tumors will undergo arteriography and receive transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    60 patients with pelvic tumors will undergo arteriography and without transcatheter arterial embolization of pelvic tumors prior to surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    Arteriography and precision preoperative embolization
    Other Intervention Name(s)
    Transcatheter arterial embolization, Therapeutic angiography, Selective arterial embolization
    Intervention Description
    Arteriography and transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.
    Intervention Type
    Procedure
    Intervention Name(s)
    Arteriography
    Intervention Description
    Arteriography of pelvic tumors 0-24 hours prior to surgery.
    Primary Outcome Measure Information:
    Title
    Perioperative blood loss
    Description
    Perioperative blood loss measured intraoperatively
    Time Frame
    Measured intraoperatively
    Secondary Outcome Measure Information:
    Title
    Adverse events related to angiography or embolization
    Description
    Including symptoms of nerve compression, pelvic organ ischemia injury
    Time Frame
    Within 2 postoperative days
    Title
    Adverse events related to surgery
    Description
    including poor wound healing，nerve injury，pelvic organ dysfunction
    Time Frame
    Within 30 postoperative days
    Title
    Vascularization grade of pelvic tumors
    Description
    it contains four grades：poor、moderate、rich、abundant
    Time Frame
    At the angiographic procedure prior to embolization performed 0-24 hours before surgery
    Title
    postoperative blood loss
    Description
    blood loss measured through the drainage within 2 postoperative days
    Time Frame
    Within 2 postoperative days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    XIN ZHI
    Phone
    861088326220
    Email
    zhixindd@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    PING YIN
    Phone
    861088326220
    Email
    13810080018@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    XIN ZHI
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

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