Non-invasive detection of electrical signals from the stomach after major pancreas surgery
| ISRCTN | ISRCTN33085217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33085217 |
| IRAS number | 305302 |
| Secondary identifying numbers | 10062, IRAS 305302 |
- Submission date
- 14/09/2023
- Registration date
- 23/04/2024
- Last edited
- 08/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Major pancreas resection surgery (pancreaticoduodenectomy), which is performed in patients with pancreas and duodenal cancer, is complex and has a high rate of complication. A part of this operation involves disconnecting the stomach from its normal position and reconnecting it to the small intestine. This often results in ‘delayed gastric emptying’, where the stomach moves abnormally and is not able to receive and digest food in the normal way. Patients who suffer from this complication are unable to eat or drink for a few weeks after their surgeries, causing prolonged hospital stays and significant patient suffering. The exact mechanism for this complication is not well understood, making it difficult to predict which patients will have delayed gastric emptying after surgery. Different techniques for connecting the stomach to the small intestine have been developed but it is unclear which of these has the greatest potential to prevent this complication. The contracting action of the stomach is coordinated by electrical signals, much like that in the heart. Recently, a new technology termed ‘Body Surface Gastric Mapping’ has been developed to measure these electrical signals non-invasively from the skin, similar to the manner in which an ECG analyses the electrical impulses from the heart. Using this technology, specific patterns have been shown in patients with various disorders of the stomach. This study aims to use this new technology to analyse the pattern of electrical signals from the stomach in patients who have had major pancreas surgery and who may go on to develop delayed gastric emptying. This will help to predict which patients are likely to have this complication and develop better techniques for preventing and treating it in the future.
Who can participate?
Adult patients aged over 18 years old undergoing pancreaticoduodenectomy for malignant or benign disease of the pancreas, distal bile duct or duodenum
What does the study involve?
Body surface gastric mapping will be used to analyse gastric electrical activity in patients before and at multiple time points after pancreaticoduodenectomy. These data will be correlated with patient-reported symptoms of delayed gastric emptying.
What are the possible benefits and risks of participating?
There are no benefits to the participants of the study. There is a theoretical risk of skin allergy to the adhesive used on the electrode array, but this has not occurred in other studies.
Where is the study run from?
University Hospital Coventry And Warwickshire (UK)
When is the study starting and how long is it expected to run for?
May 2021 to July 2025
Who is funding the study?
The study is funded by the Newcastle Hospitals Charity Fund (UK)
Who is the main contact?
Dr Keno Mentor, keno.mentor@nhs.net
Contact information
Public, Scientific, Principal Investigator
Newcastle University
Newcastle
NE1 7RU
United Kingdom
 ORCID ID |
0000-0001-8260-6660 |
|---|---|
| Phone | +44 (0)7534021907 |
| keno.mentor@nhs.net |
Study information
| Study design | Multi-centre prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format |
| Scientific title | Body surface gastric mapping to determine gastric motility patterns associated with delayed gastric emptying after pancreaticoduodenectomy |
| Study acronym | GEMAP |
| Study objectives | Major pancreatic surgery results in electrical aberrations in the stomach which cause delayed gastric emptying |
| Ethics approval(s) |
Approved 08/06/2022, North West - Greater Manchester Central Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, United Kingdom; +44 (0)207 1048 007; gmcentral.rec@hra.nhs.uk), ref: 22/NW/0148 |
| Health condition(s) or problem(s) studied | Delayed gastric emptying in patients who undergo pancreaticoduodenectomy |
| Intervention | Participants will undergo Body Surface Gastric Mapping (BSGM) at multiple points in their patient journey. BSGM involves applying a multi-electrode array to the surface of the abdominal wall, which detects and analyses electrical signals from the stomach. The detector will be left in place for 4 hours and cause the patient no pain and minimal discomfort. During this procedure, the patient will also log their abdominal symptoms (e.g. nausea) using a smartphone application designed specifically for this study. In so doing, the patient’s symptoms will be correlated with the BSGM analysis. This procedure will be carried out at multiple time points: - before surgery - on the fifth day following surgery - once a week until discharge - 3 months after discharge - 6 months following discharge **Please note that the above schedule has been changed in subsequent amendments to: - before surgery - on the 4th day following surgery - on the day of discharge - 6 months following discharge |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gastric Alimetry |
| Primary outcome measure | Wave spectral (frequency and amplitude), spatial (wave directional vector) and stability (rhythm index) parameters measured using gastric Alimetry at the following timepoints: pre-operatively, day 4 postoperatively, at discharge and 6 months postoperatively. |
| Secondary outcome measures | 1. Quality of life measured using the Patient Assessment of upper GastroIntestinal disorders-Quality of Life (PAGI QoL) questionnaire at 6 months 2. Patient satisfaction measured using a bespoke questionnaire designed by the researchers at 6 months |
| Overall study start date | 01/05/2021 |
| Completion date | 31/07/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | Patients undergoing pancreaticoduodenectomy for malignant or benign disease of the pancreas, distal bile duct or duodenum |
| Key exclusion criteria | 1. Under 18 years of age 2. Previous gastric surgery 3. Post-operative complications requiring surgical intervention 4. Major wound sepsis or rash 5. History of skin allergies or extreme sensitivity to cosmetics or lotions 6. Pregnant women 7. Vulnerable groups e.g. cognitive impairment or inability to give consent |
| Date of first enrolment | 01/12/2022 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Sponsor information
Hospital/treatment centre
Newcastle Joint Research Office
Level 1, Regent Point
Newcastle upon Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 (0)191 233 6161 |
|---|---|
| nuth.nuthsponsorship@nhs.net | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Non-identifiable and anonymised data and findings will be published in peer-reviewed journals and presented at national and international conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Keno Mentor (keno.mentor@nhs.net). Patient consent includes granting permission for the dissemination of non-identifiable data. |
Editorial Notes
08/05/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/07/2023 to 31/12/2024.
2. The overall study end date was changed from 31/12/2024 to 31/07/2025.
13/12/2023: Study's existence confirmed by the HRA North West - Greater Manchester Central Research Ethics Committee (UK).
