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临床试验/NCT04948879
NCT04948879Unknown不适用

A Review of Surgical Outcomes for Patients Undergoing En-bloc Vascular Resection and Reconstruction as Part of Exenteration for Advanced Pelvic Malignancy

St Vincent's University Hospital, Ireland0 个研究点目标入组 100 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Morbidity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Morbidity

时间窗: July 2016 - July 2021

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

次要结局

  • Blood loss(July 2016 - July 2021)
  • Length of stay(July 2016 - July 2021)
  • Mortality(July 2016 - July 2021)
  • Graft patency/function(July 2016 - July 2021)
  • Resection status(July 2016 - July 2021)

研究者

发起方
St Vincent's University Hospital, Ireland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Des Winter

Professor Des C Winter

St Vincent's University Hospital, Ireland

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