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Completed

NCT Number: NCT06673719

Comparing Pertechnetate SPECT/CT and Intragastric Pressure During Nutrient Drink for Gastric Accommodation

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Sains Malaysia

Kota Bharu, Kelantan, 16150, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Healthy volunteers

Inclusion criteria

  • Patient is above 18 years-old.
  • No current gastrointestinal symptoms
  • No previous gastrointestinal illness such as peptic ulcer disease or gastritis
  • No chronic medical illness such as chronic neurological, cardiovascular, pulmonary, endocrine and hematological disorders
  • Does not fulfill Rome IV criteria for functional dyspepsia

Exclusion criteria

  • • Had undergone any abdominal surgery except appendicectomy, tubal ligation or Caesarean section
  • Use of medications such as metoclopramide, domperidone, erythromycin and itopride that may alter gastrointestinal function and motility
  • Pregnant woman

Treatment and study plan

99mTc-pertechnetate SPECT/CT

Radiation

This procedure is similar to standard Meckel's diverticulum scan, with the addition of SPECT/CT acquisition to measure gastric volume.

Combined High-Resolution Manometry-Nutrient Drink Test

Procedure

Proximal gastric high-resolution manometry was done concurrently with nutrient drink test to measure proximal gastric function.

Primary outcomes

  1. 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)

    • Feasibility assessed as technical success (number of participants completing each procedure).
  2. Duration (time) of each procedural session

    Time frame: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)

    • Feasibility assessed as procedural duration (time taken to complete one procedure)
  3. Incidence of adverse event

    Time frame: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)

    • Tolerability assessed as incidence of adverse event over study period using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Secondary outcomes

  1. Gastric volume measured using SPECT/CT

    Time frame: During the procedure, 1 day

    • 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.
  2. Proximal gastric pressure measured using high-resolution manometry

    Time frame: During the procedure, 1 day

    • 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.
  3. Nutrient drink tolerance

    Time frame: During the procedure, 1 day

    • Maximum tolerated volume (in mL): Number of drink volume required to achieve satiety
  4. Dyspeptic symptoms measured using numerical rating scales

    Time frame: During the procedure, 1 day

    • 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.
  5. Satiation score measured using numerical rating scales

    Time frame: During the procedure, 1 day

    • Satiation (presented as satiation-unit): Numerical rating scale with verbal descriptors (from 0 to 5: 0 means "not full", 5 means "maximum fullness")

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

Comparative Validity of 99mTc-pertechnetate SPECT/CT and Mean Intragastric Pressure During Nutrient Drink in the Measurement of Gastric Accommodation

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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