The Role of Vascular Reconstruction in the Setting of Pelvic Exenteration

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Reconstruction in Pelvic Exenterative Surgery
• Intervention / Treatment: Procedure: Vascular resection/reconstruction

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Matthew Fahy, MB; Phone Number: 00353874510237; Email: MFahy94@gmail.com
• Study Contact Backup: Name: Michael Kelly, MD; Email: kellym11@tcd.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Vascular resection/reconstruction; The resection of a major blood vessel with or without reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Post-operative complications (<30 days), as measured by the Clavien-Dindo scale	July 2016 - July 2021

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: St Vincent's University Hospital, Ireland
• Investigators: Study Chair: Desmond Winter, MD, St. Vincent's Healthcare Group

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PelvEx 6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Patient data will be anonymised by participating PelvEx centres and then shared with the collaborative.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No