Gastric EmptyingSCATTERNCT06391255
Reference Values for Gastric Emptying Scintigraphy After Bariatric Surgery
An observational study of Gastric Emptying and Bariatric Surgery, run by Rijnstate Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Emptying, Bariatric Surgery
- What is being tested?
- scintigraphy
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 May 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Gastric Emptying, Bariatric Surgery
- Being tested
- scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scintigraphyOther
oesophageal and gastric emptying
| Study group | Role | What they receive |
|---|---|---|
| Normal weight loss group | TWL between 25% and 35% Receives: Other: scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
reference values for RYGB and GS patients
gastric emptying (T1/2 [min], retention [%/min], caloric emptying [cal/min], GE curve over time)
Measured: 2-3 years
to describe SPECT/CT images and determine its benefit for anatomical correlation in asymptomatic (reference) and symptomatic population.
Measured: 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]
Measured: 2-3 years
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
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start29 May 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric EmptyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06391255
- Sponsor's protocol ID
- 2023-2345
- Acronym
- SCATTER
- Status last verified
- Mar 2025
- First submitted
- 25 Apr 2024
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values for Gastric Emptying Scintigraphy After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06391255
- Acronym / sponsor ID
- SCATTER / 2023-2345
- Conditions
- Gastric Emptying, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal weight loss group | – | Other: scintigraphyTWL between 25% and 35% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scintigraphyoesophageal and gastric emptying | Other | Normal weight loss group |
Primary outcome
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)
to describe SPECT/CT images and determine its benefit for anatomical correlation in asymptomatic (reference) and symptomatic population.
Time frame: 2-3 years
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]
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Emptying and Bariatric Surgery, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reference values for RYGB and GS patients (time frame: 2-3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.