EmbolizationNCT05633134
Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes
A study testing Arteriography and precision preoperative embolization and Arteriography in people with Embolization and Pelvic Tumor, run by Peking University People's Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Embolization, Pelvic Tumor
- What is being tested?
- Arteriography and precision preoperative embolization and Arteriography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary or metastatic pelvic tumor
- Confirmed by contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) of the pelvic
- Planned surgical resection
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Embolization, Pelvic Tumor
- Being tested
- Arteriography and precision preoperative embolization, Arteriography
- Medical subject headings
- Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arteriography and precision preoperative embolizationProcedure or surgery
Also called Transcatheter arterial embolization, Therapeutic angiography, Selective arterial embolization
Arteriography and transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery.
ArteriographyProcedure or surgery
Arteriography of pelvic tumors 0-24 hours prior to surgery.
| Study group | Role | What they receive |
|---|---|---|
| Precision preoperative embolization | Experimental | 60 patients with pelvic tumors will undergo arteriography and receive transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery. Receives: Procedure: Arteriography and precision preoperative embolization |
| Control group | Active comparator | 60 patients with pelvic tumors will undergo arteriography and without transcatheter arterial embolization of pelvic tumors prior to surgery. Receives: Procedure: Arteriography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative blood loss
Perioperative blood loss measured intraoperatively
Measured: Measured intraoperatively
Secondary outcomes (4)
Adverse events related to angiography or embolization
Including symptoms of nerve compression, pelvic organ ischemia injury
Measured: Within 2 postoperative days
Adverse events related to surgery
including poor wound healing，nerve injury，pelvic organ dysfunction
Measured: Within 30 postoperative days
Vascularization grade of pelvic tumors
it contains four grades：poor、moderate、rich、abundant
Measured: At the angiographic procedure prior to embolization performed 0-24 hours before surgery
postoperative blood loss
blood loss measured through the drainage within 2 postoperative days
Measured: Within 2 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Feb 2023 (estimated)
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmbolizationStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi Xin, Peking University People's Hospital
- Investigators
- XIN ZHI, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633134
- Sponsor's protocol ID
- PPE-PT
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2022
- Last updated
- 1 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Preoperative Embolization of Pelvic Tumors to Improve Surgical Outcomes
- ClinicalTrials.gov ID
- NCT05633134
- Acronym / sponsor ID
- PPE-PT
- Conditions
- Embolization, Pelvic Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision preoperative embolization | Experimental | Procedure: Arteriography and precision preoperative embolization60 patients with pelvic tumors will undergo arteriography and receive transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery. |
| Control group | Active comparator | Procedure: Arteriography60 patients with pelvic tumors will undergo arteriography and without transcatheter arterial embolization of pelvic tumors prior to surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary or metastatic pelvic tumor
- Confirmed by contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT) of the pelvic
- Planned surgical resection
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arteriography and precision preoperative embolizationAlso: Transcatheter arterial embolization, Therapeutic angiography, Selective arterial embolizationArteriography and transcatheter arterial embolization of pelvic tumors 0-24 hours prior to surgery. | Procedure or surgery | Precision preoperative embolization |
| ArteriographyArteriography of pelvic tumors 0-24 hours prior to surgery. | Procedure or surgery | Control group |
Primary outcome
Perioperative blood loss
Time frame: Measured intraoperatively
Perioperative blood loss measured intraoperatively
4 secondary outcomes
Adverse events related to angiography or embolization
Time frame: Within 2 postoperative days
Adverse events related to surgery
Time frame: Within 30 postoperative days
Vascularization grade of pelvic tumors
Time frame: At the angiographic procedure prior to embolization performed 0-24 hours before surgery
postoperative blood loss
Time frame: Within 2 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XIN ZHI principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Arteriography and precision preoperative embolization and Arteriography in people with Embolization and Pelvic Tumor, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XIN ZHI (861088326220, zhixindd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood loss (time frame: Measured intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.