Clinical trial NCT04948879: The Role of Vascular Reconstruction in the Setting of Pelvic Exenteration
Official title: A Review of Surgical Outcomes for Patients Undergoing En-bloc Vascular Resection and Reconstruction as Part of Exenteration for Advanced Pelvic Malignancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vascular Reconstruction in Pelvic Exenterative Surgery
Lead sponsor: St Vincent's University Hospital, Ireland
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Morbidity
timeFrame: July 2016 - July 2021
Secondary outcomes:
measure: Blood loss
timeFrame: July 2016 - July 2021
measure: Length of stay
timeFrame: July 2016 - July 2021
measure: Graft patency/function
timeFrame: July 2016 - July 2021
measure: Resection status
timeFrame: July 2016 - July 2021
measure: Mortality
timeFrame: July 2016 - July 2021
Other outcomes:
Locations:
Study officials:
affiliation: St. Vincent's Healthcare Group
name: Desmond Winter, MD
role: STUDY_CHAIR
References: