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

NCT ID: NCT06673719

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-03-15

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.

Conditions

Healthy Volunteers; Functional Dyspepsia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

SPECT/CT or HRM-NDT

Group Type: EXPERIMENTAL

99mTc-pertechnetate SPECT/CT

Intervention Type: 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

Intervention Type: PROCEDURE

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

Interventions

99mTc-pertechnetate SPECT/CT

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

Intervention Type: RADIATION

Combined High-Resolution Manometry-Nutrient Drink Test

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Nashrulhaq Tagiling, MSc

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yeong Yeh Lee, MD, PhD

Role: STUDY_DIRECTOR

Universiti Sains Malaysia

Locations

Universiti Sains Malaysia

Kota Bharu, Kelantan, Malaysia

Countries

Malaysia

Other Identifiers

USM/JEPeM/19040249

Identifier Type: -

Identifier Source: org_study_id