Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

Sponsor

Peking University People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05633134

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Embolization Pelvic Tumor	Procedure: Arteriography and precision preoperative embolization Procedure: Arteriography	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Oct 31, 2024

Arms and Interventions

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: Transcatheter arterial embolization Therapeutic angiography 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.

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:

Transcatheter arterial embolization

Therapeutic angiography

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.

Outcome Measures

Primary Outcome Measures

Perioperative blood loss [Measured intraoperatively]
Perioperative blood loss measured intraoperatively

Secondary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking University People's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhi Xin, Doctor, Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT05633134

Other Study ID Numbers:

PPE-PT

First Posted:

Dec 1, 2022

Last Update Posted:

Dec 1, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pelvic Neoplasms

Study Results

No Results Posted as of Dec 1, 2022