Reference Values for Gastric Emptying Scintigraphy After Bariatric Surgery (SCATTER)

Oesophageal and gastric scintigraphy evaluates the function of the gastrointestinal system including variables such as oesophageal transit and gastric emptying (GE). Some variables are known to change after bariatric surgery. In patients that have symptoms of pain or nausea after bariatric surgery, oesophageal and gastric scintigraphy plays an important role in determining the nature of symptoms and is necessary for adequate treatment. However, literature on reference values in the bariatric population are scarce. At this moment, quantitative evaluation of the scintigraphy cannot be performed and conclusions are based on visual interpretation. There is a need for a standardised scintigraphy protocol for the population that underwent bariatric surgery taking into account the changed anatomy and physiology. Then, reference values that describe the oesophageal transit and GE assessed using scintigraphy have to be determined.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Emptying; Bariatric Surgery
• Intervention / Treatment: Other: scintigraphy

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

In this study, we will include 50 patients who underwent bariatric surgery (RYGB and SG), with uncomplicated procedure, postoperative period of two years and "normal" weight loss (25% < TWL < 35%). Participants are required to have an uncomplicated post-operative procedure and "normal" weight loss as GE might be connected to complications and/or weight loss results. Duration of inclusion period will be 2024-2025.

Description

Inclusion Criteria:

• Age between 18 and 65 years;
• RYGB or SG as primary bariatric surgery;
• A 2 year post-operative period without significant peri-operative or postoperative complications that could affect oesophageal transit, GE, or weight loss;
• "Normal" weight loss, according to our expectations (25% < TWL < 35%);
• Participants must be able to adhere to the study visit schedule and protocol requirements;
• Participants must be able to give informed consent (IC) prior to any study procedures;
• Willing to be informed about incidental findings of pathology and approving of reporting this to their general physician.

Exclusion Criteria:

• Pre-existent oesophageal or gastric motility disorders, dysphagia, reflux, dumping syndrome, (postprandial) abdominal pain, neurological or metabolic conditions that significantly affect oesophageal or gastric motility;
• When using proton pump inhibitors (PPI) or H2-antagonists, the inability to stop using them for 3 days;
• Using opioids;
• Previous oesophago-gastric surgery, other than bariatric surgery;
• Unable to stop smoking for 24h;
• Pregnancy or breast-feeding;
• Patients with a drug or alcohol addiction;
• Gluten intolerance;
• Intolerance to tracer ingredients;
• Participating in another scientific study at the same time, if this study interferes with the current study in any way.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal weight loss group; TWL between 25% and 35%	Other: scintigraphy; oesophageal and gastric emptying

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reference values for RYGB and GS patients	gastric emptying (T1/2 [min], retention [%/min], caloric emptying [cal/min], GE curve over time)	2-3 years
to describe SPECT/CT images and determine its benefit for anatomical correlation in asymptomatic (reference) and symptomatic population.		2-3 years
to define reference values for RYGB- and SG-patients for oesophageal scintigraphy after bariatric surgery using an optimised protocol;	transit time [min], emptying rate [%/min]	2-3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
to explore the correlation of GE and oesophageal transit, and weight loss results or symptoms, using prospective data from this study and retrospective data from symptomatic patients and similar studies previously	2-3 years

Collaborators and Investigators

• Sponsor: Rijnstate Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023-2345

Drug and device information, study documents

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