Gastric Emptying After Sleeve Gastrectomy (EMRISS)

Gastric Emptying Measured With MRI and Scintigraphy in Patients With Successful Versus Unsuccessful Weight Loss After Sleeve Gastrectomy

Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss [TWL] > 35%) and insufficient weight loss (TWL < 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI.

Study Overview

• Status: Recruiting
• Conditions: Gastric Emptying; Bariatric Surgery
• Intervention / Treatment: Other: MRI and scintigraphy

Detailed Description

Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. Patients' weight loss response on SG varies widely and is difficult to predict. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss [TWL] > 35%) and insufficient weight loss (TWL < 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI. MRI is a non-invasive imaging method which provides more detailed images of the SG compared to the conventionally used scintigraphy scans.

• Study Type: Observational
• Enrollment (Estimated): 6

Contacts and Locations

• Study Contact: Name: Veerbeek; Phone Number: +31 880052115; Email: tveerbeek@rijnstate.nl

Study Locations

• Netherlands
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815AD
      • Recruiting
      • Rijnstate Hospital
      • Contact: Veerbeek; Phone Number: +31 880052115; Email: tveerbeek@rijnstate.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Women after sleeve gastrectomy with either good or poor weight loss

Description

Inclusion Criteria:

• Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with either TWL < 25% or TWL > 35%.
• Patients who had a follow-up period of 2-3 years after sleeve gastrectomy

Exclusion Criteria:

• Maximum BMI >50 kg/m2
• Patients with a disease known to affect appetite, gastric emptying or gastrointestinal motility
• Patients who are unable to stop medications that affect gastric emptying and/or motility prior to measurements. It is depending on t1/2 for how long they need to stop medication
• Patients who started menopause
• Patients with gastrointestinal problems or, gastric or intestinal diseases
• Patients with a drug or alcohol addiction
• Patients who are unable to stop smoking for 24h
• Patients who are pregnant or lactating
• Patients who have an intolerance or allergy for one of the components of the test product
• Patients who have a contra-indication to MRI scanning

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Poor weight loss group; Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL < 25%	Other: MRI and scintigraphy; Gastric emptying measured with MRI and scintigraphy
Successful weight loss group; Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL > 35%	Other: MRI and scintigraphy; Gastric emptying measured with MRI and scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastric emptying compared between patients with poor and successful weight loss	Gastric emptying (T1/2 [min] and retention [%/min])	2-3 years
Gastric emptying compared between measured with MRI and scintigraphy	Gastric emptying (T1/2 [min] and retention [%/min])	2-3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss	Volume (sleeve size [mL] and gastric acid [mL])	2-3 years
to assess the association between gastric emptying rate and gastric sleeve characteristics in each group	association between outcome 1, 2 and 3	2-3 years
to compare subjective ratings of gastric fullness and wellbeing between patients with successful and unsuccessful weight loss	questionnaires (VAS-scale, MAIA, HADS, EBBS, Power of food scale, and Food tolerance test)	2-3 years

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: Wageningen University and Research

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: MRI; Gastric emptying; Scintigraphy; Gastric sleeve
• Other Study ID Numbers: 2020-1690

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No