Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

Pelvic Tumor Clinical Trial

Official title:

Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05633134
• Other study ID #: PPE-PT
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Embolization
• Pelvic Neoplasms
• Pelvic Tumor

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