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Non-invasive detection of electrical signals from the stomach after major pancreas surgery

Body surface gastric mapping to determine gastric motility patterns associated with delayed gastric emptying after pancreaticoduodenectomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN33085217
Enrollment
50
Registered
2024-04-23
Start date
2022-12-01
Completion date
Unknown
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delayed gastric emptying in patients who undergo pancreaticoduodenectomy Digestive System

Interventions

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 de

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients undergoing pancreaticoduodenectomy for malignant or benign disease of the pancreas, distal bile duct or duodenum

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

England, United Kingdom

Contacts

Public ContactKeno Mentor
keno.mentor@nhs.net+44 (0)7534021907

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026