Minimally invasive oesophageal adenocarcinoma sentinel node biopsy 4.0

ISRCTN	ISRCTN71969151
DOI	https://doi.org/10.1186/ISRCTN71969151
Secondary identifying numbers	11479

Submission date: 05/04/2012
Registration date: 24/07/2012
Last edited: 06/07/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/a-study-looking-finding-first-lymph-nodes-cancer-may-spread-people-having-surgery-cancer-food-pipe

Contact information

Mr Shajahan Wahed
Scientific

Northern Oesophago-Gastric Cancer Unit
Newcastle upon Tyne Hospitals NHS Foundation Trust
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom

Email	shajahan.wahed@nuth.nhs.uk

Study information

Study design	Observational trial
Primary study design	Observational
Secondary study design	Other
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A prospective, observational study evaluating a minimally invasive technique of identifying the sentinel lymph nodes in patients undergoing surgery for oesophageal adenocarcinoma
Study objectives	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(s)	NRES Committee North EastCounty Durham & Tees Valley, First MREC 04/10/2011, ref: 11/NE/0262
Health condition(s) or problem(s) studied	Upper Gastro-Intestinal Cancer
Intervention	Laparoscopic gamma probe identification of abdominal sentinel lymph nodes following endoscopic peritumoural technetium injection.
Intervention type	Other
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 study start date	20/02/2012
Completion date	01/10/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 40; UK Sample Size: 40
Key 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
Key exclusion criteria	1. Incurable disease 2. Not suitable for laparoscopy
Date of first enrolment	20/02/2012
Date of final enrolment	01/10/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Royal Victoria Infirmary

Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Royal Victoria Infirmary
Leazes Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom

Website	http://www.newcastle-hospitals.org.uk/
"ROR"	https://ror.org/05p40t847

Funders

Funder type

University/education

Bupa Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)

Location: United Kingdom

Royal College of Surgeons of England
Private sector organisation / Associations and societies (private and public)

Alternative name(s): RCS
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	results	16/09/2016		No	No

Editorial Notes

06/07/2018: Publication reference added.
11/04/2016: No publications found, verifying study status with principal investigator