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

Not Applicable

Completed

• Conditions: Healthy Volunteers; Functional Dyspepsia

• Registration Number: NCT06673719
• Lead Sponsor: Universiti Sains Malaysia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-02-27
• Study Completion: 2020-03-15
• Status Verified: 2024-10
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-11-01
• Last Update Submitted: 2024-11-01
• Study First Posted: 2024-11-05
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of adverse event	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.
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)	• Feasibility assessed as technical success (number of participants completing each procedure).
Duration (time) of each procedural session	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)

Secondary Outcome Measures

Name	Time	Method
Gastric volume measured using SPECT/CT	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.
Proximal gastric pressure measured using high-resolution manometry	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.
Nutrient drink tolerance	During the procedure, 1 day	• Maximum tolerated volume (in mL): Number of drink volume required to achieve satiety
Dyspeptic symptoms measured using numerical rating scales	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.
Satiation score measured using numerical rating scales	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")

Trial Locations

Locations (1)

Universiti Sains Malaysia; 🇲🇾 Kota Bharu, Kelantan, Malaysia