RecruitingACTRN12623000966695

Delineating gastric emptying after major gastro-oesophageal surgery using real time MRI


Sponsor

Alfred Health

Enrollment

36 participants

Start Date

Aug 2, 2021

Study Type

Interventional

Conditions

Summary

Background:: Optimising gastric conduit emptying post oesophagectomy is key to improving morbidity outcomes in a cohort of patients with increasingly long survivorship. It is thought that peristaltic function and resultant emptying of the gastric conduit improves over time. However, the relationship between peristalsis and conduit emptying has not been precisely delineated, nor has the presumed recovery. Aims:: In this study, we aim to investigate dynamic MRI as a technique to measure gastric conduit peristalsis in the mediastinum. We will use it to quantify the degree of peristalsis in the established gastric conduit and assess its correlation with emptying. We will also use quality of life and adverse symptom questionnaires to look for a relationship between peristalsis and gastrointestinal quality of life. Hypothesis: Dynamic MRI is an accurate way to measure gastric conduit peristalsis and conduit emptying. Peristaltic activity recovers post oesophagectomy and is more effective in narrower conduits. Brief Methods: Post oesophagectomy patients will be recruited greater than 2 years post oesophagectomy. Dynamic MRI will be performed, and questionnaires and demographic data collected Patients greater than 2 years post oesophagectomy and gastric conduit reconstruction will be prospectively recruited. Static and Dynamic MRIs will be performed in the supine position post consumption of a semisolid meal. Speed, length, and amplitude of peristaltic waves will be measured at 4 time points over a 20-minute period. Gastric Motility Index mm2/s (GMI) will be calculated (velocity x amplitude of peristaltic wave). Gastric conduit volumes will be calculated at the start and end of each MRI.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

When a person has oesophageal cancer and undergoes oesophagectomy — surgery to remove the oesophagus — surgeons reconstruct the digestive tract by pulling the stomach up into the chest to act as a replacement tube (called a gastric conduit). This conduit needs to empty properly to prevent problems like reflux, regurgitation, and nutritional difficulties. It was previously thought that the conduit's ability to empty improves over time, but this has never been precisely measured. This study is using dynamic MRI scans — taken while a participant eats a semisolid meal — to measure peristalsis (the wave-like muscular contractions that push food along) and emptying of the gastric conduit in patients who had oesophagectomy more than 2 years ago. The results will be compared with a control group of people with normal digestive anatomy. The study will also collect quality of life and symptom questionnaires. You may be eligible if you are at least 2 years post-oesophagectomy and gastric conduit reconstruction. A separate control group of adults with normal digestive anatomy is also being recruited. The study excludes people with other gastrointestinal conditions or medications known to affect stomach movement. The study is based at Alfred Health in Melbourne and has an age range of 18 to 80.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Each participant (with a previous oesophagectomy) will present to the MRI department fasted for 8 hours. The MRI will take approximately 30 minutes. Immediately prior to the MRI, the participant wil

Each participant (with a previous oesophagectomy) will present to the MRI department fasted for 8 hours. The MRI will take approximately 30 minutes. Immediately prior to the MRI, the participant will consume a semi solid porridge meal, consisting of 34 grams of oats, sugar, honey, and milk powder. An MRI will be performed by a specialised MRI radiographer, and the following sequences will be attained: T2 Volume acquisition, followed by T2 weighted true fast imaging with steady state free precession (TRUFI) free breathing sequence for 4 minutes. This block will be repeated 4 times. Then a final volume acquisition T2 Volume sequence will be completed. A specialised radiologist or surgeon investigator will be present for the scan to ensure all sequences are adequately completed. No IV contrast will be used. No further follow-up scans are required.


Locations(1)

VIC, Australia

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