## Protocol Section
### Identification Module
**NCT ID:** NCT04948879

**Brief Title:** 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

#### Organization Study ID Info
**ID:** PelvEx 6
#### Organization
**Class:** OTHER
**Full Name:** St Vincent's University Hospital, Ireland
### Status Module
#### Completion Date
**Date:** 2022-01-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2021-07-21

**Type:** ACTUAL

**Last Update Submit Date:** 2021-07-20

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-11-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-08-01

**Type:** ESTIMATED

**Status Verified Date:** 2021-07

#### Study First Post Date
**Date:** 2021-07-02
**Type:** ACTUAL
**Study First Submit Date:** 2021-06-24
**Study First Submit QC Date:** 2021-06-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** St Vincent's University Hospital, Ireland

#### Responsible Party

**Investigator Affiliation:** St Vincent's University Hospital, Ireland

**Investigator Full Name:** Professor Des Winter

**Investigator Title:** Professor Des C Winter

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Vascular Reconstruction in Pelvic Exenterative Surgery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: Vascular resection/reconstruction

**Label:** Vascular reconstruction

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Vascular reconstruction

**Description:** The resection of a major blood vessel with or without reconstruction

**Name:** Vascular resection/reconstruction

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Post-operative complications (\<30 days), as measured by the Clavien-Dindo scale

**Measure:** Morbidity

**Time Frame:** July 2016 - July 2021

#### Secondary Outcomes

**Description:** Blood loss (mL)

**Measure:** Blood loss

**Time Frame:** July 2016 - July 2021

**Description:** Duration of stay in hospital post-procedure

**Measure:** Length of stay

**Time Frame:** July 2016 - July 2021

**Description:** Whether or not the reconstruction is functioning

**Measure:** Graft patency/function

**Time Frame:** July 2016 - July 2021

**Description:** Resection margins (R0, R1 or R2)

**Measure:** Resection status

**Time Frame:** July 2016 - July 2021

**Description:** Proportion of patients who die within 30 days of the procedure

**Measure:** Mortality

**Time Frame:** July 2016 - July 2021

### Eligibility Module

**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 Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mfahy94@gmail.com

**Name:** Matthew Fahy, MB

**Phone:** 00353874510237

**Role:** CONTACT

**Contact 2:**

**Email:** kellym11@tcd.ie

**Name:** Michael Kelly, MD

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** St. Vincent's Healthcare Group

**Name:** Desmond Winter, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Description:** Patient data will be anonymised by participating PelvEx centres and then shared with the collaborative.

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
