Vascular Reconstruction in Pelvic Exenterative SurgeryNCT04948879
The Role of Vascular Reconstruction in the Setting of Pelvic Exenteration
An observational study of Vascular Reconstruction in Pelvic Exenterative Surgery, run by St Vincent's University Hospital, Ireland.
Trial summary
Local invasion or abutment of a major vascular structure was once a major deterrent to planned oncological resection. Improvements in radiological assessment and vascular surgical techniques have enabled resection of major blood vessels where focally involved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Reconstruction in Pelvic Exenterative Surgery
- What is being tested?
- Vascular resection/reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 1 Jan 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 years who undergo resection/reconstruction of a major blood vessel as part of pelvic exenteration for a locally advanced or recurrent pelvic (rectal, urological, gynaecological, sarcomatous) malignancy.
Who may be able to join
- Histologically proven locally advanced or recurrent pelvic cancer (all subtypes, RECTAL, UROLOGICAL, GYNAE, SARCOMA)
- Aged over 18 years
- Undergoing a multi-visceral extended pelvic resection
- Requiring a vascular resection with or without the need for reconstruction as part of pelvic exenteration
Who cannot join
- Strong evidence of metastatic or peritoneal disease
- No histological evidence of vascular structures resected at time of operation
- Insufficient patient follow-up (Minimum of 30 days)
- Insufficient information on post-operative follow-up of graft patency/function
Trial locations and contacts
No sites are listed yet.
Michael Kelly, MD contact
About this study
Official title: A Review of Surgical Outcomes for Patients Undergoing En-bloc Vascular Resection and Reconstruction as Part of Exenteration for Advanced Pelvic Malignancy
Local invasion or abutment of a major vascular structure was once a major deterrent to planned oncological resection. Improvements in radiological assessment and vascular surgical techniques have enabled resection of major blood vessels where focally involved. However, most of this has been conducted in the context of cancers of sarcomatous, hepaticopancreaticobilary or otolaryngological origin, with little evidence detailing the experience in the context of pelvic malignancy. The aim of this retrospective review is to examine the indications for, techniques used and surgical outcomes of vascular reconstruction in the setting of pelvic exenterative surgery.
Read the detailed description
The role of pelvic exenteration in the management of locally advanced and recurrent pelvic malignancies is ever evolving, with technical advancements enabling surgeons to perform more radical resections, offering a potential cure to many patients who would have once been deemed inoperable. As surgical oncology has shifted towards higher-volume, specialist centres in a bid to improve outcomes, surgeons have used greater experience to re-evaluate what can be considered as resectable disease. This is best exemplified by a trend towards en bloc vascular excision and reconstruction where tumours abut or focally invade adjacent vasculature. Whereas involvement of a major vascular structure remains a relative contraindication to surgery in some units (1), certain specialist centres around the world are increasingly reporting on the feasibility of this approach.
It is accepted that achieving an R0 resection is the most significant prognostic factor for overall survival (OS) in exenterative surgery. Conversely, involvement of the lateral compartment is a poor prognostic variable, in large part due to the difficulty obtaining a negative resection margin without compromising neurovascular structures(2). Improvements in pre-operative radiological assessment, particularly with respect to angiography, have facilitated appropriate patient and treatment selection, while advancements in the field of vascular surgery have made the procedure technically feasible.
However, there is no clear consensus on the role of vascular reconstruction in curative treatment of advanced pelvic malignancy, owing to a paucity of published data. Initial reports and series have shown promising results, but these are almost exclusively single-surgeon experiences with small numbers and heterogenous populations. Therefore, there is a need for collaborative data to assess the impact and success of such surgical strategies.
The aim of this retrospective review is to examine the indications for, techniques used and surgical outcomes of vascular reconstruction in the setting of pelvic exenterative surgery at a multicentre level in order to inform future practice, with a particular focus on whether or not it significantly increases the morbidity in the short-term.
- Being tested
- Vascular resection/reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular resection/reconstructionProcedure or surgery
The resection of a major blood vessel with or without reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Vascular reconstruction | Patients who have undergone resection with or without reconstruction of a major blood vessel in the context of surgery for a locally advanced pelvic malignancy. This will mostly refer to patients who have had resection/reconstruction of their internal iliac vessels, or less likely common iliacs. Receives: Procedure: Vascular resection/reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Post-operative complications (<30 days), as measured by the Clavien-Dindo scale
Measured: July 2016 - July 2021
Secondary outcomes (5)
Blood loss
Blood loss (mL)
Measured: July 2016 - July 2021
Length of stay
Duration of stay in hospital post-procedure
Measured: July 2016 - July 2021
Graft patency/function
Whether or not the reconstruction is functioning
Measured: July 2016 - July 2021
Resection status
Resection margins (R0, R1 or R2)
Measured: July 2016 - July 2021
Mortality
Proportion of patients who die within 30 days of the procedure
Measured: July 2016 - July 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Reconstruction in Pelvic Exenterative SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Vincent's University Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Des Winter, St Vincent's University Hospital, Ireland
- Investigators
- Desmond Winter, MD, Study chair, St. Vincent's Healthcare Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948879
- Sponsor's protocol ID
- PelvEx 6
- Status last verified
- Jul 2021
- First submitted
- 24 Jun 2021
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be anonymised by participating PelvEx centres and then shared with the collaborative.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Review of Surgical Outcomes for Patients Undergoing En-bloc Vascular Resection and Reconstruction as Part of Exenteration for Advanced Pelvic Malignancy
- ClinicalTrials.gov ID
- NCT04948879
- Acronym / sponsor ID
- PelvEx 6
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St Vincent's University Hospital, IrelandUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 2 Jul 2021 (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.
Local invasion or abutment of a major vascular structure was once a major deterrent to planned oncological resection. Improvements in radiological assessment and vascular surgical techniques have enabled resection of major blood vessels where focally involved. However, most of this has been conducted in the context of cancers of sarcomatous, hepaticopancreaticobilary or otolaryngological origin, with little evidence detailing the experience in the context of pelvic malignancy. The aim of this retrospective review is to examine the indications for, techniques used and surgical outcomes of vascular reconstruction in the setting of pelvic exenterative surgery.
Detailed description
The role of pelvic exenteration in the management of locally advanced and recurrent pelvic malignancies is ever evolving, with technical advancements enabling surgeons to perform more radical resections, offering a potential cure to many patients who would have once been deemed inoperable. As surgical oncology has shifted towards higher-volume, specialist centres in a bid to improve outcomes, surgeons have used greater experience to re-evaluate what can be considered as resectable disease. This is best exemplified by a trend towards en bloc vascular excision and reconstruction where tumours abut or focally invade adjacent vasculature. Whereas involvement of a major vascular structure remains a relative contraindication to surgery in some units (1), certain specialist centres around the world are increasingly reporting on the feasibility of this approach.
It is accepted that achieving an R0 resection is the most significant prognostic factor for overall survival (OS) in exenterative surgery. Conversely, involvement of the lateral compartment is a poor prognostic variable, in large part due to the difficulty obtaining a negative resection margin without compromising neurovascular structures(2). Improvements in pre-operative radiological assessment, particularly with respect to angiography, have facilitated appropriate patient and treatment selection, while advancements in the field of vascular surgery have made the procedure technically feasible.
However, there is no clear consensus on the role of vascular reconstruction in curative treatment of advanced pelvic malignancy, owing to a paucity of published data. Initial reports and series have shown promising results, but these are almost exclusively single-surgeon experiences with small numbers and heterogenous populations. Therefore, there is a need for collaborative data to assess the impact and success of such surgical strategies.
The aim of this retrospective review is to examine the indications for, techniques used and surgical outcomes of vascular reconstruction in the setting of pelvic exenterative surgery at a multicentre level in order to inform future practice, with a particular focus on whether or not it significantly increases the morbidity in the short-term.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular reconstruction | – | Procedure: Vascular resection/reconstructionPatients who have undergone resection with or without reconstruction of a major blood vessel in the context of surgery for a locally advanced pelvic malignancy. This will mostly refer to patients who have had resection/reconstruction of their internal iliac vessels, or less likely common iliacs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 years who undergo resection/reconstruction of a major blood vessel as part of pelvic exenteration for a locally advanced or recurrent pelvic (rectal, urological, gynaecological, sarcomatous) malignancy.
Key inclusion criteria (4 listed)
- Histologically proven locally advanced or recurrent pelvic cancer (all subtypes, RECTAL, UROLOGICAL, GYNAE, SARCOMA)
- Aged over 18 years
- Undergoing a multi-visceral extended pelvic resection
- Requiring a vascular resection with or without the need for reconstruction as part of pelvic exenteration
Key exclusion criteria (4 listed)
- Strong evidence of metastatic or peritoneal disease
- No histological evidence of vascular structures resected at time of operation
- Insufficient patient follow-up (Minimum of 30 days)
- Insufficient information on post-operative follow-up of graft patency/function
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 |
|---|---|---|
| Vascular resection/reconstructionThe resection of a major blood vessel with or without reconstruction | Procedure or surgery | Vascular reconstruction |
Primary outcome
Morbidity
Time frame: July 2016 - July 2021
Post-operative complications (<30 days), as measured by the Clavien-Dindo scale
5 secondary outcomes
Blood loss
Time frame: July 2016 - July 2021
Length of stay
Time frame: July 2016 - July 2021
Graft patency/function
Time frame: July 2016 - July 2021
Resection status
Time frame: July 2016 - July 2021
Mortality
Time frame: July 2016 - July 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No. Patient data will be anonymised by participating PelvEx centres and then shared with the collaborative.
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.
Michael Kelly, MD contact
Desmond Winter, MD study chair
St. Vincent's Healthcare Group
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Reconstruction in Pelvic Exenterative Surgery, run by St Vincent's University Hospital, Ireland.
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 4 inclusion and 4 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 21 Jul 2021. 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 Matthew Fahy, MB (00353874510237, mfahy94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity (time frame: July 2016 - July 2021). 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 21 Jul 2021.