The Role of Vascular Reconstruction in the Setting of Pelvic Exenteration

NCT ID: NCT04948879

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-01-01

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.

Conditions

Vascular Reconstruction in Pelvic Exenterative Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Vascular resection/reconstruction

Intervention Type: PROCEDURE

The resection of a major blood vessel with or without reconstruction

Interventions

Vascular resection/reconstruction

The resection of a major blood vessel with or without reconstruction

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Vincent's University Hospital, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Professor Des Winter

Professor Des C Winter

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Desmond Winter, MD

Role: STUDY_CHAIR

St. Vincent's Healthcare Group

Central Contacts

Matthew Fahy, MB

Role: CONTACT

mfahy94@gmail.com

00353874510237

Michael Kelly, MD

Role: CONTACT

kellym11@tcd.ie

Other Identifiers

PelvEx 6

Identifier Type: -

Identifier Source: org_study_id