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Trial Title:
Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes
NCT ID:
NCT05633134
Condition:
Embolization
Pelvic Tumor
Conditions: Official terms:
Pelvic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Investigator)
Intervention:
Intervention type:
Procedure
Intervention name:
Arteriography and precision preoperative embolization
Description:
Arteriography and transcatheter arterial embolization of pelvic tumors 0-24 hours prior
to surgery.
Arm group label:
Precision preoperative embolization
Other name:
Transcatheter arterial embolization
Other name:
Therapeutic angiography
Other name:
Selective arterial embolization
Intervention type:
Procedure
Intervention name:
Arteriography
Description:
Arteriography of pelvic tumors 0-24 hours prior to surgery.
Arm group label:
Control group
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
February 1, 2023
Completion date:
October 31, 2024
Lead sponsor:
Agency:
Peking University People's Hospital
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05633134
