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Comparative Validity of 99mTc-pertechnetate SPECT/CT and Mean Intragastric Pressure During Nutrient Drink in the Measurement of Gastric Accommodation
Sponsor study identifier
interventional
20
1 country
1
Study Start
October 1, 2019
Actual (reported)Primary Completion
February 27, 2020
Actual (reported)Study Completion
March 15, 2020
Actual (reported)Functional dyspepsia (FD) is a common gastrointestinal disorder which can present with early satiety, postprandial fullness, epigastric pain and burning sensation in the absence of underlying disease. The most troubling symptom is weight loss, prevalent in up to 40% of FD patients and is often associated with impaired gastric accommodation. Gastric accommodation by definition is a reflex, mediated vagally which causes reduction in gastric tone, increased in compliance and increment in gastric volume post meal ingestion. It allows large volumes of liquid or solid ingestion without causing postprandial symptoms. Impairment of gastric accommodation has been linked to gastrointestinal symptoms which includes nausea, bloating, early satiety, weight loss and epigastric pain. There are several studies aimed to assess efficacy in the treatment of functional dyspeptic patients. A myriad of tests can measure gastric accommodation such as gastric barostat and single photon emission computed tomography (SPECT). An alternative study known as the nutrient drink test has also been proposed and can be combined with high-resolution manometry. So far, none of the nuclear medicine centers in Malaysia are providing clinical service for radionuclide gastric accommodation study. The gold standard for gastric accommodation assessment is the gastric barostat method. However, the technique is invasive and caused discomfort to patients. Radionuclide gastric accommodation study using 99mTc-pertechnetate with SPECT/CT is a non-invasive method that can be used to assess patient with FD and enables quantitative evaluation of treatment response to medications. Hence, the role of non-invasive gastric volume assessment with 99mTc-pertechenate SPECT/CT in the evaluation of healthy individuals was studied first, and then compared with intragastric pressure measurements from high-resolution manometry and nutrient drink test.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 15, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2019
Actual (reported)February 27, 2020
Actual (reported)March 15, 2020
Actual (reported)October 30, 2024
Actual (reported)November 5, 2024
Actual (reported)Number of participants completing each procedure
• Feasibility assessed as technical success (number of participants completing each procedure).
From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
Duration (time) of each procedural session
• Feasibility assessed as procedural duration (time taken to complete one procedure)
From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
Incidence of adverse event
• Tolerability assessed as incidence of adverse event over study period using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
Gastric volume measured using SPECT/CT
During the procedure, 1 day
Proximal gastric pressure measured using high-resolution manometry
During the procedure, 1 day
Nutrient drink tolerance
During the procedure, 1 day
Dyspeptic symptoms measured using numerical rating scales
During the procedure, 1 day
Satiation score measured using numerical rating scales
During the procedure, 1 day
This procedure is similar to standard Meckel's diverticulum scan, with the addition of SPECT/CT acquisition to measure gastric volume.
Proximal gastric high-resolution manometry was done concurrently with nutrient drink test to measure proximal gastric function.
Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150, Malaysia
Yeong Yeh Lee, MD, PhD
Universiti Sains Malaysia
20 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2024
First Posted
November 5, 2024
Study Start
October 1, 2019
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 27, 2020
Actual (reported)Study Completion
March 15, 2020
Actual (reported)Last Updated
November 5, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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