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

Not Applicable

Recruiting

• Conditions: Oesophagectomy; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Surgery - Other surgery; Gastric conduit dysmotility; Gastric Conduit Emptying Failure

• Registration Number: ACTRN12623000966695
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-09-06
• Last Update Posted: 12 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Interventional Group:
> 2 years post oesophagectomy

Control Group:
Normal gastrointestinal Anatomy

Exclusion Criteria

Interventional group:
Known gastrointestinal dysmotility
Medications that may affect gastric motility
Recurrence of Cancer
Prior gastrointestinal operations (other than oesopahgectomy) that may affect intestinal transit

Control group:
Known gastrointestinal dysmotility
Medications that may affect gastric motility
Prior gastrointestinal operations (other than oesopahgectomy) that may affect intestinal transit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastric Peristalsis is the primary outcome. To measure this, we will assess each TRUFI (dynamic) phase of the MRI and measure the amplitude and velocity of each peristaltic wave. We will calculate the Gastric Motility Index as a surrogate measure of peristalsis by multiplying the amplitude (mm) by the velocity (mm/sec) of the largest peristaltic wave in each block. [Peristaltic waves will be quantified during each MRI TRUFI (dynamic) block at 5 minutes, 11 minutes, 17 minutes and 23 minutes. ]

Secondary Outcome Measures

Name	Time	Method
Gastric Emptying is a secondary outcome. This will be assess by calculating the conduit volume at the beginning and end of the MRI scanning period, and measuring the % of emptying. [The first and last volume scans will be performed approximately 20 minutes apart. ];Allens Reflux and Regurgitation score [At the time of the MRI, at least 2 years post oesophagectomy ];Dakkak Dysphagia Scores[At the time of the MRI, at least 2 years post oesophagectomy ];Sigstad dumping scores,[At the time of the MRI, at least 2 years post oesophagectomy ];Rand SF-35 Quality of Life scores[At the time of the MRI, at least 2 years post oesophagectomy ]