Condition category
Cancer
Date applied
05/04/2012
Date assigned
24/07/2012
Last edited
11/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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
-
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 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

NRES Committee North East—County 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 measures

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

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

http://www.newcastle-hospitals.org.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

11/04/2016: No publications found, verifying study status with principal investigator