Article Text

Download PDFPDF

Protocol
Cytoreductive surgery (CRS) with hyperthermic intraoperative peritoneal chemotherapy (HIPEC) versus standard of care (SoC) in people with peritoneal metastases from colorectal, ovarian or gastric origin: protocol for a systematic review and individual participant data (IPD) meta-analyses of effectiveness and cost-effectiveness
  1. Kurinchi Gurusamy1,
  2. Claire L Vale2,
  3. Elena Pizzo3,
  4. R Bhanot1,
  5. Brian R Davidson1,4,
  6. Tim Mould5,
  7. Muntzer Mughal6,
  8. Mark Saunders7,
  9. Omer Aziz7,
  10. Sarah O'Dwyer7
  1. 1Division of Surgery and Interventional Science, University College London, London, UK
  2. 2Meta-analysis Group, MRC Clinical Trials Unit at UCL, London, UK
  3. 3Department of Applied Health Research, University College London, London, UK
  4. 4Department of HPB Surgery, Royal Free London NHS Foundation Trust, London, UK
  5. 5Gynaecological Oncology, University College London Hospitals NHS Trust, London, UK
  6. 6Surgery, University College London Hospital NHS Foundation Trust, London, UK
  7. 7Colorectal and Peritoneal Oncology Centre, The Christie NHS Foundation Trust, Manchester, UK
  1. Correspondence to Dr Kurinchi Gurusamy; k.gurusamy{at}ucl.ac.uk

Abstract

Introduction There is uncertainty about whether cytoreductive surgery (CRS)+hyperthermic intraoperative peritoneal chemotherapy (HIPEC) improves survival and/or quality of life compared with standard of care (SoC) in people with peritoneal metastases who can withstand major surgery.

Primary objectives To compare the relative benefits and harms of CRS+HIPEC versus SoC in people with peritoneal metastases from colorectal, ovarian or gastric cancers eligible to undergo CRS+HIPEC by a systematic review and individual participant data (IPD) meta-analysis.

Secondary objectives To compare the cost-effectiveness of CRS+HIPEC versus SoC from a National Health Service (NHS) and personal social services perspective using a model-based cost–utility analysis.

Methods and analysis We will perform a systematic review of literature by updating the searches from MEDLINE, Embase, Cochrane library, Science Citation Index as well as trial registers. Two members of our team will independently screen the search results and identify randomised controlled trials comparing CRS+HIPEC versus SoC for inclusion based on full texts for articles shortlisted during screening. We will assess the risk of bias in the trials and obtain data related to baseline prognostic characteristics, details of intervention and control, and outcome data related to overall survival, disease progression, health-related quality of life, treatment related complications and resource utilisation data. Using IPD, we will perform a two-step IPD, that is, calculate the adjusted effect estimate from each included study and then perform a random-effects model meta-analysis. We will perform various subgroup analyses, meta-regression and sensitivity analyses. We will also perform a model-based cost–utility analysis to assess whether CRS+HIPEC is cost-effective in the NHS setting.

Ethics and dissemination This project was approved by the UCL Research Ethics Committee (Ethics number: 16023/001). We aim to present the findings at appropriate international meetings and publish the review, irrespective of the findings, in a peer-reviewed journal.

PROSPERO registration number CRD42019130504.

  • health economics
  • chemotherapy
  • qualitative research
  • oncology
  • surgery
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

Statistics from Altmetric.com

Footnotes

  • Contributors KG and CLV wrote the manuscript. The manuscript was critically revised by EP, RB, BRD, TM, MM, MS, OA, SO. KG is the guarantor of this manuscript.

  • Funding This study is funded by the National Institute for Health Research (NIHR) HTA programme (HTA – Project: 17/135/02). Role of funder: The funder sought independent peer review before funding and approved the protocol. All dissemination must be approved by the funder before dissemination. Sponsor: University College London.

  • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

  • Competing interests The clinical practice of the clinicians in the project: TM, MM, MS, OA and SO may be altered by the findings of the review.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Ethics approval This project was approved by the UCL Research Ethics Committee (Ethics number: 16023/001).

  • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

  • Author note The authorship of the systematic review manuscript will comprise the Project Management Group (the authors of this manuscript), International Advisory Group, representatives from the included trials and patient representatives. We aim to present the findings at appropriate international meetings and publish the review, irrespective of the findings, in a peer-reviewed journal.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.