Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

Not Applicable

Not yet recruiting

• Conditions: Embolization; Pelvic Tumor
• Interventions: Procedure: Arteriography and precision preoperative embolization; Procedure: Arteriography

• Registration Number: NCT05633134
• Lead Sponsor: Peking University People's Hospital

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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-20
• Study First Submitted QC: 2022-11-30
• Last Update Submitted: 2022-11-30
• Study First Posted: 2022-12-01
• Last Update Posted: 2022-12-01
• Study Start: 2023-02-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Precision preoperative embolization	Arteriography and 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.
Control group	Arteriography	60 patients with pelvic tumors will undergo arteriography and without transcatheter arterial embolization of pelvic tumors prior to surgery.

Primary Outcome Measures

Name	Time	Method
Perioperative blood loss	Measured intraoperatively	Perioperative blood loss measured intraoperatively

Secondary Outcome Measures

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