Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

November 30, 2022 updated by: Zhi Xin, Peking University People's Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Precision preoperative embolization
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
Arteriography and transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.
Other Names:
  • Therapeutic angiography
  • Transcatheter arterial embolization
  • Selective arterial embolization
Active Comparator: Control group
60 patients with pelvic tumors will undergo arteriography and without transcatheter arterial embolization of pelvic tumors prior to surgery.
Procedure: Arteriography
Arteriography of pelvic tumors 0-24 hours prior to surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative blood loss
Time Frame: Measured intraoperatively
Perioperative blood loss measured intraoperatively
Measured intraoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: XIN ZHI, Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

August 31, 2024

Study Completion (Anticipated)

October 31, 2024

Study Registration Dates

First Submitted

November 20, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

December 1, 2022

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPE-PT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pelvic Tumor

Clinical Trials on Arteriography and precision preoperative embolization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe