Clinical trial NCT06673719: Comparing Pertechnetate SPECT/CT and Intragastric Pressure During Nutrient Drink for Gastric Accommodation
Official title: Comparative Validity of 99mTc-pertechnetate SPECT/CT and Mean Intragastric Pressure During Nutrient Drink in the Measurement of Gastric Accommodation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Functional Dyspepsia
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Monocentric, non-randomized sequence, pilot and feasibility study
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants completing each procedure
timeFrame: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
measure: Duration (time) of each procedural session
timeFrame: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
measure: Incidence of adverse event
timeFrame: From the initiation of the first study procedure until the completion of the second procedures (up to 30 days)
Secondary outcomes:
measure: Gastric volume measured using SPECT/CT
timeFrame: During the procedure, 1 day
measure: Proximal gastric pressure measured using high-resolution manometry
timeFrame: During the procedure, 1 day
measure: Nutrient drink tolerance
timeFrame: During the procedure, 1 day
measure: Dyspeptic symptoms measured using numerical rating scales
timeFrame: During the procedure, 1 day
measure: Satiation score measured using numerical rating scales
timeFrame: During the procedure, 1 day
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Universiti Sains Malaysia
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: Yeong Yeh Lee, MD, PhD
role: STUDY_DIRECTOR
References: