Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

Peking University

Status: Not yet enrolling

Conditions: Embolization; Pelvic Tumor

Treatments: Procedure: Arteriography; Procedure: Arteriography and precision preoperative embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT05633134

PPE-PT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Precision preoperative embolization

Experimental group

Description:

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

Treatment:

Procedure: Arteriography and precision preoperative embolization

Control group

Active Comparator group

Description:

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

Treatment:

Procedure: Arteriography