Reference Values for Gastric Emptying Scintigraphy After Bariatric Surgery

Bariatric Surgery Clinical Trial

— SCATTER  

Official title:

Reference Values for Gastric Emptying Scintigraphy After Bariatric Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06391255
• Other study ID #: 2023-2345
• Status: Not yet recruiting
• Start date: May 15, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2024
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Gastric Emptying

Intervention

Other:
• scintigraphy
oesophageal and gastric emptying

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	to describe SPECT/CT images and determine its benefit for anatomical correlation in asymptomatic (reference) and symptomatic population.		2-3 years
Primary	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	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