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Enrolling by Invitation

NCT Number: NCT06391255

Reference Values for Gastric Emptying Scintigraphy After Bariatric Surgery

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.

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Key information

Conditions

Gastric Emptying Bariatric Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijnstate Hospital

Arnhem, Gelderland, 6815AD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

scintigraphy

Other

oesophageal and gastric emptying

Primary outcomes

  1. reference values for RYGB and GS patients

    Time frame: 2-3 years

    gastric emptying (T1/2 [min], retention [%/min], caloric emptying [cal/min], GE curve over time)

  2. to describe SPECT/CT images and determine its benefit for anatomical correlation in asymptomatic (reference) and symptomatic population.

    Time frame: 2-3 years

  3. to define reference values for RYGB- and SG-patients for oesophageal scintigraphy after bariatric surgery using an optimised protocol;

    Time frame: 2-3 years

    transit time [min], emptying rate [%/min]

Secondary outcomes

  1. 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

    Time frame: 2-3 years

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Acronym: SCATTER

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2024
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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