Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Mr Shajahan Wahed
ORCID ID
Contact details
Northern Oesophago-Gastric Cancer Unit
Newcastle upon Tyne Hospitals NHS Foundation Trust
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
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shajahan.wahed@nuth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11479
Study information
Scientific title
A prospective, observational study evaluating a minimally invasive technique of identifying the sentinel lymph nodes in patients undergoing surgery for oesophageal adenocarcinoma
Acronym
Study hypothesis
Oesophagectomy for cancer carries some of the highest morbidity and mortality risks of any elective surgical procedure. The incidence of oesophageal adenocarcinoma in the Western world is increasing dramatically and shows no signs of slowing down. Endoscopic surveillance of Barretts oesophagus is also anticipated to increase numbers of patients with high-grade dysplasia of the oesophagus who may require resectional surgery. Studies indicate that the routinely performed extended lymphadenectomy contributes significantly to the risks of surgery. However, determining which patients do not require a radical lymphadenectomy is limited by the relatively low sensitivity and specificity of pre-operative staging investigations. Minimally invasive techniques such as laparoscopic gastric mobilisation and thoracoscopic oesophageal mobilisation have been developed to reduce surgical trauma. These techniques need to be equally as radical in terms of the lymphadenectomy although this can be difficult in some cases. The sentinel lymph node (SLN) concept is that if the first draining lymph node in proximity to a cancer is clear of cancer cells then no other nodes should be involved.
A minimally invasive resection technique coupled to a sensitive minimally invasive SLN assessment could potentially reduce surgical morbidity by identifying patients who could have less extensive surgery without compromising oncological clearance. The SLN status might be the determining factor in deciding whether a patient is indeed suitable for minimally invasive surgery. Furthermore, the technique could also be applied to tailor surgery for those patients having open resections and determine the lymph node status for patients having endoscopic mucosal and submucosal resections for very superficial adenocarcinoma.
Ethics approval
NRES Committee North EastCounty Durham & Tees Valley, First MREC 04/10/2011, ref: 11/NE/0262
Study design
Observational trial
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Upper Gastro-Intestinal Cancer
Intervention
Laparoscopic gamma probe identification of abdominal sentinel lymph nodes following endoscopic peritumoural technetium injection.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Sentinel lymph node identification
2. Numbers of patients in whom the abdominal sentinel lymph node is identified after study completion
Secondary outcome measures
No secondary outcome measures
Overall trial start date
20/02/2012
Overall trial end date
01/10/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All patients with potentially curable lower third oesophageal adenocarcinoma or oesophagogastric junction adenocarcinoma planned to undergo curative twostage oesophagectomy
2. Male and female participants
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 40; UK Sample Size: 40
Participant exclusion criteria
1. Incurable disease
2. Not suitable for laparoscopy
Recruitment start date
20/02/2012
Recruitment end date
01/10/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
Royal Victoria Infirmary
Leazes Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Bupa Foundation
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Funder name
Royal College of Surgeons of England
Alternative name(s)
RCS
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in https://onlinelibrary.wiley.com/doi/epdf/10.1002/bjs.9938