An interventional study of 99mTc-pertechnetate SPECT/CT and Combined High-Resolution Manometry-Nutrient Drink Test in Healthy Volunteers and Functional Dyspepsia, sponsored by Universiti Sains Malaysia. Completed at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by Universiti Sains Malaysia · Not applicable, Interventional, and Basic science
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.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 20 is below the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Universiti Sains Malaysia is the lead sponsor of 171 studies on the registry; 48 are open to participants now.
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Healthy volunteers
Inclusion Criteria:
Exclusion Criteria:
Had undergone any abdominal surgery except appendicectomy, tubal ligation or Caesarean section
Radiation: 99mTc-pertechnetate SPECT/CT · Procedure: Combined High-Resolution Manometry-Nutrient Drink Test
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.
Number of participants completing each procedure
• Feasibility assessed as technical success (number of participants completing each procedure).
Time frame: 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)
Time frame: 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.
Time frame: 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
• Gastric volume (in mL): Fasting state, postprandial state (after single-serving of 250 mL nutrient drink). All are to be measured in one session and as one outcome.
Time frame: During the procedure, 1 day
Proximal gastric pressure measured using high-resolution manometry
• Proximal gastric pressure (in mmHg): baseline (fasting) pressure recording, prandial pressure recording, postprandial pressure recording. All are to be measured in one session and as one outcome.
Time frame: During the procedure, 1 day
Nutrient drink tolerance
• Maximum tolerated volume (in mL): Number of drink volume required to achieve satiety
Time frame: During the procedure, 1 day
Dyspeptic symptoms measured using numerical rating scales
• Dyspeptic symptom responses: Numerical rating scale with verbal descriptors on 4 symptoms i.e., epigastric pain, bloating, fullness, nausea (from 0 to 3: 0 means "no symptoms", 3 means "severe"). All are to be measured in one session using one instrument and as one outcome.
Time frame: During the procedure, 1 day
Satiation score measured using numerical rating scales
• Satiation (presented as satiation-unit): Numerical rating scale with verbal descriptors (from 0 to 5: 0 means "not full", 5 means "maximum fullness")
Time frame: During the procedure, 1 day
Plan to share: Undecided
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Universiti Sains Malaysia