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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05633134
Other study ID # PPE-PT
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date October 31, 2024

Study information

Verified date November 2022
Source Peking University People's Hospital
Contact XIN ZHI
Phone 861088326220
Email zhixindd@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date October 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Arteriography and precision preoperative embolization
Arteriography and transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.
Arteriography
Arteriography of pelvic tumors 0-24 hours prior to surgery.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Perioperative blood loss Perioperative blood loss measured intraoperatively Measured intraoperatively
Secondary Adverse events related to angiography or embolization Including symptoms of nerve compression, pelvic organ ischemia injury Within 2 postoperative days
Secondary Adverse events related to surgery including poor wound healing,nerve injury,pelvic organ dysfunction Within 30 postoperative days
Secondary 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
Secondary postoperative blood loss blood loss measured through the drainage within 2 postoperative days Within 2 postoperative days
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