The Role of Vascular Reconstruction in the Setting of Pelvic Exenteration

• Conditions: Vascular Reconstruction in Pelvic Exenterative Surgery
• Interventions: Procedure: Vascular resection/reconstruction

• Registration Number: NCT04948879
• Lead Sponsor: St Vincent's University Hospital, Ireland

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.

Study Timeline

• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-06-24
• Status Verified: 2021-07
• Study First Posted: 2021-07-02
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21
• Study Start: 2021-08-01
• Primary Completion: 2021-11-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vascular reconstruction	Vascular resection/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.

Primary Outcome Measures

Name	Time	Method
Morbidity	July 2016 - July 2021	Post-operative complications (\<30 days), as measured by the Clavien-Dindo scale

Secondary Outcome Measures

Name	Time	Method
Length of stay	July 2016 - July 2021	Duration of stay in hospital post-procedure
Mortality	July 2016 - July 2021	Proportion of patients who die within 30 days of the procedure
Graft patency/function	July 2016 - July 2021	Whether or not the reconstruction is functioning
Resection status	July 2016 - July 2021	Resection margins (R0, R1 or R2)
Blood loss	July 2016 - July 2021	Blood loss (mL)