Retroperitoneal NeoplasmsIOVA-rptNCT06803251
The Role of the Vascular Surgeon in Oncologic Surgery of Abdominal and Pelvic Retroperitoneal Masses
An observational study of Retroperitoneal Neoplasms, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Retroperitoneal tumors (RPTs - retroperitoneal tumors) are neoplasms that originate from the soft tissues of the retroperitoneum and in their more invasive forms can involve the retroperitoneal organs and large abdominal and pelvic vascular structures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retroperitoneal Neoplasms
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jul 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 belonging to the UU.OO. General Surgery, Urology and Gynecological Oncology of the IRCCS University Hospital of Bologna, with diagnosis of intra-abdominal or pelvic retroperitoneal mass with involvement of vascular structures and indication for surgical treatment of removal of the mass which requires the presence of a vascular surgeon. This indication is supported by international guidelines and represents normal clinical practice in these patients.
Who may be able to join
- Patient diagnosed with a retroperitoneal mass involving the abdominal and/or pelvic vascular structures and requiring surgical removal
- Planned surgical treatment with intra-operative assistance from the vascular surgeon
- Obtaining informed consent
- Age 18 years
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS AOU di Bologna Policlinico di Sant'Orsola
Bologna, Italia, 40138
Mauro Prof Gargiulo, MD, 0512143288, mauro.gargiulo2@unibo.it
About this study
Official title: Il Ruolo Del Chirurgo Vascolare Nella Chirurgia Oncologica Delle Masse Addominali E Pelviche Retroperitoneali
Retroperitoneal tumors (RPTs - retroperitoneal tumors) are neoplasms that originate from the soft tissues of the retroperitoneum and in their more invasive forms can involve the retroperitoneal organs and large abdominal and pelvic vascular structures. They are divided into benign tumors (20%), of which teratomas and tumors of neurogenic origin are the most frequent, and malignant tumors (80%), of which the most frequent are sarcomas (RPS - retroperitoneal sarcoma)1.
These are often large lesions, which can exceed 15 cm in diameter and which develop asymptomatically until the surrounding structures are involved. The initial symptoms are often represented by lumbar pain and abdominal distension which occur after multiple organ involvement.
Read more
To date, the treatment of choice is surgical excision of the mass with the aim of obtaining a clean resection margin R0 (macroscopically and microscopically free of disease) or R1 (with margin only macroscopically free of disease).
The most recent literature on this topic demonstrates how the treatment of RPS in specialized centers by a multidisciplinary team that works as a team and uses cutting-edge diagnostic and surgical techniques can improve the R0/R1 resection rate and overall survival. (OS)2.
The rate of intra- and post-operative surgical complications increases in direct proportion to the width of the excision; however, major complications are not associated with statistically significant differences in terms of OS, local recurrence (LR) and survival in the absence of distant metastases
Read the detailed description
Very large abdominal and pelvic retroperitoneal masses frequently involve the retroperitoneal vascular structures.
Data from the literature show that after spinal surgery and orthopedic surgery, oncological surgery represents a specialist branch that frequently requires intraoperative vascular surgical assistance (6.7 - 9.6% of requests)5,6
. In these cases, the surgical assistance of the vascular surgeon allows the safe removal of the mass, the possible repair of the vessels damaged during cleavage and isolation of the mass, ligation or complete reconstruction of the vascular segment involved and contributes to reducing intraoperative and postoperative complications.
The clinical relevance of the evaluation of the short- and long-term results of the study lies in the fact that the case study it is expected to obtain greatly exceeds the few already published. Knowledge of outcomes on a larger sample will help shed light on aspects such as the need for more or less extensive surgical resection and on the choice of revascularization technique.
The primary objective of the study is to evaluate the outcomes of musculoskeletal tumor removal procedures in relation to the type of vascular surgical care provided.
- Conditions
- Retroperitoneal Neoplasms
- Medical subject headings
- Retroperitoneal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of vascular issues during the procedure
Numbers of major and minor vascular issues during retroperitoneal procedures.
Measured: From the first patient enrolled to the 70th patient, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start14 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retroperitoneal NeoplasmsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauro Gargiulo, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803251
- Sponsor's protocol ID
- IOVA-rpt
- Acronym
- IOVA-rpt
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Il Ruolo Del Chirurgo Vascolare Nella Chirurgia Oncologica Delle Masse Addominali E Pelviche Retroperitoneali
- ClinicalTrials.gov ID
- NCT06803251
- Acronym / sponsor ID
- IOVA-rpt / IOVA-rpt
- Conditions
- Retroperitoneal Neoplasms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jan 2025 (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.
Retroperitoneal tumors (RPTs - retroperitoneal tumors) are neoplasms that originate from the soft tissues of the retroperitoneum and in their more invasive forms can involve the retroperitoneal organs and large abdominal and pelvic vascular structures. They are divided into benign tumors (20%), of which teratomas and tumors of neurogenic origin are the most frequent, and malignant tumors (80%), of which the most frequent are sarcomas (RPS - retroperitoneal sarcoma)1.
These are often large lesions, which can exceed 15 cm in diameter and which develop asymptomatically until the surrounding structures are involved. The initial symptoms are often represented by lumbar pain and abdominal distension which occur after multiple organ involvement.
To date, the treatment of choice is surgical excision of the mass with the aim of obtaining a clean resection margin R0 (macroscopically and microscopically free of disease) or R1 (with margin only macroscopically free of disease).
The most recent literature on this topic demonstrates how the treatment of RPS in specialized centers by a multidisciplinary team that works as a team and uses cutting-edge diagnostic and surgical techniques can improve the R0/R1 resection rate and overall survival. (OS)2.
The rate of intra- and post-operative surgical complications increases in direct proportion to the width of the excision; however, major complications are not associated with statistically significant differences in terms of OS, local recurrence (LR) and survival in the absence of distant metastases
Detailed description
Very large abdominal and pelvic retroperitoneal masses frequently involve the retroperitoneal vascular structures.
Data from the literature show that after spinal surgery and orthopedic surgery, oncological surgery represents a specialist branch that frequently requires intraoperative vascular surgical assistance (6.7 - 9.6% of requests)5,6
. In these cases, the surgical assistance of the vascular surgeon allows the safe removal of the mass, the possible repair of the vessels damaged during cleavage and isolation of the mass, ligation or complete reconstruction of the vascular segment involved and contributes to reducing intraoperative and postoperative complications.
The clinical relevance of the evaluation of the short- and long-term results of the study lies in the fact that the case study it is expected to obtain greatly exceeds the few already published. Knowledge of outcomes on a larger sample will help shed light on aspects such as the need for more or less extensive surgical resection and on the choice of revascularization technique.
The primary objective of the study is to evaluate the outcomes of musculoskeletal tumor removal procedures in relation to the type of vascular surgical care provided.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients belonging to the UU.OO. General Surgery, Urology and Gynecological Oncology of the IRCCS University Hospital of Bologna, with diagnosis of intra-abdominal or pelvic retroperitoneal mass with involvement of vascular structures and indication for surgical treatment of removal of the mass which requires the presence of a vascular surgeon. This indication is supported by international guidelines and represents normal clinical practice in these patients.
Key inclusion criteria (4 listed)
- Patient diagnosed with a retroperitoneal mass involving the abdominal and/or pelvic vascular structures and requiring surgical removal
- Planned surgical treatment with intra-operative assistance from the vascular surgeon
- Obtaining informed consent
- Age 18 years
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reduction of vascular issues during the procedure
Time frame: From the first patient enrolled to the 70th patient, an average of 3 years
Numbers of major and minor vascular issues during retroperitoneal procedures.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
Related trials for Retroperitoneal Neoplasms
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Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
Retroperitoneal Sarcoma, Liposarcoma
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Patient Reported Outcomes and Different Renal Artery Clamping Techniques During Robot Assisted Kidney Resection
Renal Cell Carcinoma (Kidney Cancer)
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Intestinal & Multivisceral Transplantation for Unresectable Mucinous Carcinoma Peritonei (TRANSCAPE)
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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.
Mauro Gargiulo, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retroperitoneal Neoplasms, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 1 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: looking for participants now, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mauro MG Gargiulo, MD (0512143288 ext. +39, mauro.gargiulo2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of vascular issues during the procedure (time frame: From the first patient enrolled to the 70th patient, an average of 3 years). 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 31 Jan 2025.