Minimally invasive oesophageal adenocarcinoma sentinel node biopsy 4.0
ISRCTN | ISRCTN71969151 |
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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
Contact information
Mr Shajahan Wahed
Scientific
Scientific
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 |
Study information
Study design | Observational trial |
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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 |
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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
NE1 4LP
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
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/ |
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https://ror.org/05p40t847 |
Funders
Funder type
University/education
Bupa Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
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)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- RCS
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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