Reference Values for Gastric Emptying Scintigraphy After... | NCT06391255

Studies
Reference Values for Gastric Emptying Scintigraphy After Bariatric Surgery

NCT06391255

Sponsor

Rijnstate Hospital

Status

Enrolling by invitation

Last Update Posted

Mar 10, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Gastric Emptying
Bariatric Surgery

Interventions

scintigraphy

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2024Actual

Primary Completion Date

May 31, 2025Estimated

Completion Date

May 31, 2025Estimated

First Submitted Date

Apr 25, 2024

First Submission Date that Met QC Criteria

Apr 25, 2024

First Posted Date

Apr 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2025

Last Update Posted Date

Mar 10, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Normal weight loss group		TWL between 25% and 35%	Other: scintigraphy

Name	Type	Description	Arm Group Labels	Other Names
scintigraphy	Other	oesophageal and gastric emptying	Normal weight loss group

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample