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 designObservational trial
Primary study designObservational
Secondary study designOther
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA prospective, observational study evaluating a minimally invasive technique of identifying the sentinel lymph nodes in patients undergoing surgery for oesophageal adenocarcinoma
Study objectivesOesophagectomy 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 Barrett’s 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 East—County Durham & Tees Valley, First MREC 04/10/2011, ref: 11/NE/0262
Health condition(s) or problem(s) studiedUpper Gastro-Intestinal Cancer
InterventionLaparoscopic gamma probe identification of abdominal sentinel lymph nodes following endoscopic peritumoural technetium injection.
Intervention typeOther
Primary outcome measure1. Sentinel lymph node identification
2. Numbers of patients in whom the abdominal sentinel lymph node is identified after study completion
Secondary outcome measuresNo secondary outcome measures
Overall study start date20/02/2012
Completion date01/10/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 40; UK Sample Size: 40
Key inclusion criteria1. 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 criteria1. Incurable disease
2. Not suitable for laparoscopy
Date of first enrolment20/02/2012
Date of final enrolment01/10/2013

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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