The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

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Abstract

Background

There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer.

Methods/Design

A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff.

Discussion

The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer.

Trial registration

The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of the study protocol.

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Most cited references 32

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Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial.

Surya S A Y Biere, Mark I van Berge Henegouwen, Kirsten W. Maas … (2012)

Surgical resection is regarded as the only curative option for resectable oesophageal cancer, but pulmonary complications occurring in more than half of patients after open oesophagectomy are a great concern. We assessed whether minimally invasive oesophagectomy reduces morbidity compared with open oesophagectomy. We did a multicentre, open-label, randomised controlled trial at five study centres in three countries between June 1, 2009, and March 31, 2011. Patients aged 18-75 years with resectable cancer of the oesophagus or gastro-oesophageal junction were randomly assigned via a computer-generated randomisation sequence to receive either open transthoracic or minimally invasive transthoracic oesophagectomy. Randomisation was stratified by centre. Patients, and investigators undertaking interventions, assessing outcomes, and analysing data, were not masked to group assignment. The primary outcome was pulmonary infection within the first 2 weeks after surgery and during the whole stay in hospital. Analysis was by intention to treat. This trial is registered with the Netherlands Trial Register, NTR TC 2452. We randomly assigned 56 patients to the open oesophagectomy group and 59 to the minimally invasive oesophagectomy group. 16 (29%) patients in the open oesophagectomy group had pulmonary infection in the first 2 weeks compared with five (9%) in the minimally invasive group (relative risk [RR] 0·30, 95% CI 0·12-0·76; p=0·005). 19 (34%) patients in the open oesophagectomy group had pulmonary infection in-hospital compared with seven (12%) in the minimally invasive group (0·35, 0·16-0·78; p=0·005). For in-hospital mortality, one patient in the open oesophagectomy group died from anastomotic leakage and two in the minimally invasive group from aspiration and mediastinitis after anastomotic leakage. These findings provide evidence for the short-term benefits of minimally invasive oesophagectomy for patients with resectable oesophageal cancer. Digestive Surgery Foundation of the Unit of Digestive Surgery of the VU University Medical Centre. Copyright © 2012 Elsevier Ltd. All rights reserved.

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Extended transthoracic resection compared with limited transhiatal resection for adenocarcinoma of the esophagus.

Jan B. F. Hulscher, Johanna W van Sandick, Angela G. E. M. de Boer … (2002)

Controversy exists about the best surgical treatment for esophageal carcinoma. We randomly assigned 220 patients with adenocarcinoma of the mid-to-distal esophagus or adenocarcinoma of the gastric cardia involving the distal esophagus either to transhiatal esophagectomy or to transthoracic esophagectomy with extended en bloc lymphadenectomy. Principal end points were overall survival and disease-free survival. Early morbidity and mortality, the number of quality-adjusted life-years gained, and cost effectiveness were also determined. A total of 106 patients were assigned to undergo transhiatal esophagectomy, and 114 to undergo transthoracic esophagectomy. Demographic characteristics and characteristics of the tumor were similar in the two groups. Perioperative morbidity was higher after transthoracic esophagectomy, but there was no significant difference in in-hospital mortality (P=0.45). After a median follow-up of 4.7 years, 142 patients had died--74 (70 percent) after transhiatal resection and 68 (60 percent) after transthoracic resection (P=0.12). Although the difference in survival was not statistically significant, there was a trend toward a survival benefit with the extended approach at five years: disease-free survival was 27 percent in the transhiatal-esophagectomy group, as compared with 39 percent in the transthoracic-esophagectomy group (95 percent confidence interval for the difference, -1 to 24 percent [the negative value indicates better survival with transhiatal resection]), whereas overall survival was 29 percent as compared with 39 percent (95 percent confidence interval for the difference, -3 to 23 percent). Transhiatal esophagectomy was associated with lower morbidity than transthoracic esophagectomy with extended en bloc lymphadenectomy. Although median overall, disease-free, and quality-adjusted survival did not differ statistically between the groups, there was a trend toward improved long-term survival at five years with the extended transthoracic approach. Copyright 2002 Massachusetts Medical Society

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Minimally invasive esophagectomy: outcomes in 222 patients.

James D Luketich, Miguel Alvelo-Rivera, Percival Buenaventura … (2003)

To assess our outcomes after minimally invasive esophagectomy (MIE). Esophagectomy has traditionally been performed by open methods. Results from most series include mortality rates in excess of 5% and hospital stays frequently greater than 10 days. MIE has the potential to improve these results, but only a few small series have been reported. This report summarizes our experience of 222 cases. From 1996 to 2002, MIE was performed in 222 patients. Indications for operation included high-grade dysplasia (n = 47) and cancer (n = 175). Neoadjuvant chemotherapy was used in 78 (35.1%) and radiation in 36 (16.2%). Initially, a laparoscopic transhiatal approach was used (n = 8), but subsequently our approach evolved to include thoracoscopic mobilization (n = 214). There were 186 men and 36 women. Median age was 66.5 years (range, 39-89). Nonemergent conversion to open procedure was required in 16 patients (7.2%). MIE was successfully completed in 206 (92.8%) patients. The median intensive care unit stay was 1 day (range, 1-30); hospital stay was 7 days (range, 3-75). Operative mortality was 1.4% (n = 3). Anastomotic leak rate was 11.7% (n = 26). At a mean follow-up of 19 months (range, 1-68), quality of life scores were similar to preoperative values and population norms. Stage specific survival was similar to open series. MIE offers results as good as or better than open operation in our center with extensive minimally invasive and open experience. In this single institution experience, we observed a lower mortality rate (1.4%) and shorter hospital stay (7 days) than most open series. Given these results, we are now developing an intergroup trial (ECOG 2202) to assess MIE in a multicenter setting.

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Author and article information

Contributors

Kerry NL Avery

Chris Metcalfe

Richard Berrisford

C Paul Barham

Jenny L Donovan

Jackie Elliott

Stephen J Falk

Rob Goldin

George Hanna

Andrew A Hollowood

Richard Krysztopik

Sian Noble

Grant Sanders

Christopher G Streets

Dan R Titcomb

Tim Wheatley

Jane M Blazeby

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central

ISSN (Electronic): 1745-6215

Publication date Collection: 2014

Publication date (Electronic): 2 June 2014

Volume: 15

Page: 200

Affiliations

[1 ]School of Social and Community Medicine, University of Bristol, 39 Whatley Road, BS8 2PS, Clifton Bristol, UK

[2 ]Department of Upper Gastrointestinal Surgery, Derriford Hospital, Derriford Road, PL6 8DH Plymouth, UK

[3 ]Division of Surgery, Head and Neck, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Marlborough Street, BS1 3NU Bristol, UK

[4 ]Gastro-Oesophageal Support and Help Group, 15 Honey Hill Road, BS15 4HG Kingswood, South Gloucestershire, UK

[5 ]Bristol Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Horfield Road, BS2 8ED Bristol, UK

[6 ]Centre for Pathology, 4th Floor Clarence Wing, St. Mary’s Hospital, Praed Street, W2 1NY London, UK

[7 ]Department of Bio-Surgery & Surgical Technology, Imperial College NHS Trust, Academic Surgical Unit, 10th Floor, QEQM Building, St. Mary’s Hospital, Praed Street, W2 1NY London, UK

[8 ]Gastroenterology & Surgical Department B57, Royal United Hospital Bath NHS Trust, Combe Park, BA1 3NG Bath, UK

Article

Publisher ID: 1745-6215-15-200

DOI: 10.1186/1745-6215-15-200

PMC ID: 4084574

PubMed ID: 24888266

SO-VID: a6be873f-633b-4abc-8d90-b3f522b843fa

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

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Abstract

Background

Methods/Design

Discussion

Trial registration

Related collections

Point-of-Care Testing for Infectious Diseases Super Collection

Most cited references 32

Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial.

Extended transthoracic resection compared with limited transhiatal resection for adenocarcinoma of the esophagus.

Minimally invasive esophagectomy: outcomes in 222 patients.

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