Idiopathic GastroparesisNCT01916460
Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients
A study testing Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) in people with Idiopathic Gastroparesis and Diabetic Gastroparesis, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
Trial summary
Patients who empty their stomach slowly may have what we call "Slow gastric emptying" or "gastroparesis". These patients can have some changes in the thickness of their stomach wall. In addition, they may have loss of some important nerve cells in their stomach muscles. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Gastroparesis, Diabetic Gastroparesis
- What is being tested?
- Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (age 18 to 80) with objective evidence of gastroparesis who will undergo surgical placement of gastric pacemaker and full thickness gastric wall biopsy. Objective evidence of gastroparesis include the following:
- Documented symptoms of gastroparesis for longer than 6 months.
- More than 7 episodes of vomiting per week
- Refractoriness or intolerance to antiemetics and prokinetic medications
- Delayed gastric emptying of solid meal (>60% gastric retention at 2 hours and >10% at 4 hours postprandial) using a standard 4-hour scintigraphic method
Who cannot join
- Patients with documented organic or intestinal pseudo-obstruction , primary eating or swallowing disorders, rumination syndrome, psychogenic vomiting, cyclic vomiting syndrome, systemic sclerosis, thyroid and adrenal disease, chemical dependency, cancer, peritoneal dialysis, pregnancy.Also, patients with history of gastric surgery such as partial gastric resection or vagatomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University HSC at El Paso
El Paso, Texas, 79912
About this study
Patients who empty their stomach slowly may have what we call "Slow gastric emptying" or "gastroparesis". These patients can have some changes in the thickness of their stomach wall. In addition, they may have loss of some important nerve cells in their stomach muscles. The loss of these cells can cause slow emptying of the stomach. Obtaining a sample from the stomach wall to examine the loss of these cells can help in diagnosing gastroparesis. Up to now, the only way to obtain a tissue sample from the stomach muscle was to undergo an operation in the surgery suite and be hospitalized for several days after the procedure. Usually, we obtain this sample while these patients are having a surgery for another purpose such as placement of a gastric stimulator (a machine which is inserted in the stomach wall to control the stomach rhythm and thus help the stomach to empty faster). Endoscopic ultrasound is an endoscope (a tube with a source of light and ultrasound installed in the tip of the tube) that can measure how thick the stomach wall is and can provide sample "biopsies" of the stomach wall which can be studied for the loss of these specialized muscles and cells.
We are proposing that samples obtained by the endoscopic ultrasound can be sufficient to diagnose "gastroparesis" and can replace the need for obtaining samples by surgery. Endoscopic ultrasound is an outpatient procedure which is not as invasive as surgery.
Read the detailed description
EUS Fine Needle Aspiration (FNA) Biopsies of the Muscularis Propria (MP) of the gastric wall in patients with gastroparesis (GP) could replace the routine use of surgical full thickness biopsies (FTB) for assessing loss of Interstitial Cell of Cajal (ICC) and cellular infiltrates in the myenteric plexus. The principal investigator investigated the efficacy and safety of EUS Fine Needle Aspiration biopsies of the Muscularis Propria of the stomach antrum in gastroparesis and compared the tissue to a surgically obtained full thickness biopsies in the same patient.
This was a prospective, nonrandomized, feasibility trial. Patients with gastroparesis who were undergoing gastric neurostimulator placement were enrolled. Patients had a gastric wall measurement by radial EUS in the body and antrum of the stomach followed by linear EUS examination and FNA of the muscularis propria in the antrum by using a 19-gauge core needle. Within 24 hours, a full-thickness biopsy specimen of the antrum was obtained surgically during neurostimulator placement. Endoscopic and surgical specimens were compared for tissue morphology, number of ICCs (c-kit stain) and enteric neurons (S-100 stain), and fibrosis (trichome) for each patient. The correlation coefficient of the ICC count per high-power field was used to compare both specimens. Continuous data were compared by using a t test.
- Conditions
- Idiopathic Gastroparesis, Diabetic Gastroparesis
- Being tested
- Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)
- Keywords
- Gastroparesis, Endoscopic ultrasound, Interstitial cell of Cajal
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)Procedure or surgery
After the subjects meet the criteria for enrollment in the study, gastroparetic patients will undergo linear EUS examination of the stomach wall one day prior to their surgery to obtain single or multiple core biopsies of the stomach body wall using the 19-gauge core biopsy needle under EUS guidance. The pathologist will be in the room to assess the adequacy of the sample after each pass. Once the pathologist deemed that the obtained sample is sufficient, the procedure will be terminated
| Study group | Role | What they receive |
|---|---|---|
| Gastroparetic patient 19G | Experimental | Endoscopic Ultrasound Fine Needle Aspiration of the gastric wall prior to surgical placement of gastric neurostimulator with 19-gauge fine core needle used for aspiration Receives: Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of EUS FNA needle to obtain gastric smooth muscle tissue
Wither FNA needle can obtain sufficient muscularis propria tissue from the gastric wall to perform histological staining for the interstitial cell of Cajal and smooth muscles markers. The specimen from the FNA needle will be compared to the standard full thickness gastric biopsy which is routinely obtained in our institution during the surgical placement of the gastric stimulator.
Measured: During the procedure ( 45 minutes)
Secondary outcomes (1)
Safety of EUS FNA of gastric wall ( wither perforation or tear developed after the procedure)
The site of EUS FNA in the stomach wall will be examined surgically for perforations and tear during surgical placement of gastric neurostimulator
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University Health Sciences Center, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed O Othman, MD, Principal investigator, Texas Tech University Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916460
- Sponsor's protocol ID
- E13052
- Status last verified
- May 2021
- First submitted
- 23 Jun 2013
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Othman MO, Davis B, Saroseik I, Torabi A, McCallum RW. EUS-guided FNA biopsy of the muscularis propria of the antrum in patients with gastroparesis is feasible and safe. Gastrointest Endosc. 2016 Feb;83(2):327-33. doi: 10.1016/j.gie.2015.06.056. Epub 2015 Aug 28.
PubMed 26318833
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraluminal Endosonography for Examination of the Structural Changes of the Stomach in Gastroparetic Patients
- ClinicalTrials.gov ID
- NCT01916460
- Acronym / sponsor ID
- E13052
- Conditions
- Idiopathic Gastroparesis, Diabetic Gastroparesis
- Keywords
- Gastroparesis, Endoscopic ultrasound, Interstitial cell of Cajal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Texas Tech University Health Sciences Center, El PasoUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who empty their stomach slowly may have what we call "Slow gastric emptying" or "gastroparesis". These patients can have some changes in the thickness of their stomach wall. In addition, they may have loss of some important nerve cells in their stomach muscles. The loss of these cells can cause slow emptying of the stomach. Obtaining a sample from the stomach wall to examine the loss of these cells can help in diagnosing gastroparesis. Up to now, the only way to obtain a tissue sample from the stomach muscle was to undergo an operation in the surgery suite and be hospitalized for several days after the procedure. Usually, we obtain this sample while these patients are having a surgery for another purpose such as placement of a gastric stimulator (a machine which is inserted in the stomach wall to control the stomach rhythm and thus help the stomach to empty faster). Endoscopic ultrasound is an endoscope (a tube with a source of light and ultrasound installed in the tip of the tube) that can measure how thick the stomach wall is and can provide sample "biopsies" of the stomach wall which can be studied for the loss of these specialized muscles and cells.
We are proposing that samples obtained by the endoscopic ultrasound can be sufficient to diagnose "gastroparesis" and can replace the need for obtaining samples by surgery. Endoscopic ultrasound is an outpatient procedure which is not as invasive as surgery.
Detailed description
EUS Fine Needle Aspiration (FNA) Biopsies of the Muscularis Propria (MP) of the gastric wall in patients with gastroparesis (GP) could replace the routine use of surgical full thickness biopsies (FTB) for assessing loss of Interstitial Cell of Cajal (ICC) and cellular infiltrates in the myenteric plexus. The principal investigator investigated the efficacy and safety of EUS Fine Needle Aspiration biopsies of the Muscularis Propria of the stomach antrum in gastroparesis and compared the tissue to a surgically obtained full thickness biopsies in the same patient.
This was a prospective, nonrandomized, feasibility trial. Patients with gastroparesis who were undergoing gastric neurostimulator placement were enrolled. Patients had a gastric wall measurement by radial EUS in the body and antrum of the stomach followed by linear EUS examination and FNA of the muscularis propria in the antrum by using a 19-gauge core needle. Within 24 hours, a full-thickness biopsy specimen of the antrum was obtained surgically during neurostimulator placement. Endoscopic and surgical specimens were compared for tissue morphology, number of ICCs (c-kit stain) and enteric neurons (S-100 stain), and fibrosis (trichome) for each patient. The correlation coefficient of the ICC count per high-power field was used to compare both specimens. Continuous data were compared by using a t test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastroparetic patient 19G | Experimental | Procedure: Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)Endoscopic Ultrasound Fine Needle Aspiration of the gastric wall prior to surgical placement of gastric neurostimulator with 19-gauge fine core needle used for aspiration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients (age 18 to 80) with objective evidence of gastroparesis who will undergo surgical placement of gastric pacemaker and full thickness gastric wall biopsy. Objective evidence of gastroparesis include the following:
Key exclusion criteria (1 listed)
- Patients with documented organic or intestinal pseudo-obstruction , primary eating or swallowing disorders, rumination syndrome, psychogenic vomiting, cyclic vomiting syndrome, systemic sclerosis, thyroid and adrenal disease, chemical dependency, cancer, peritoneal dialysis, pregnancy.Also, patients with history of gastric surgery such as partial gastric resection or vagatomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)After the subjects meet the criteria for enrollment in the study, gastroparetic patients will undergo linear EUS examination of the stomach wall one day prior to their surgery to obtain single or multiple core biopsies of the stomach body wall using the 19-gauge core biopsy needle under EUS guidance. The pathologist will be in the room to assess the adequacy of the sample after each pass. Once the pathologist deemed that the obtained sample is sufficient, the procedure will be terminated | Procedure or surgery | Gastroparetic patient 19G |
Primary outcome
The ability of EUS FNA needle to obtain gastric smooth muscle tissue
Time frame: During the procedure ( 45 minutes)
Wither FNA needle can obtain sufficient muscularis propria tissue from the gastric wall to perform histological staining for the interstitial cell of Cajal and smooth muscles markers. The specimen from the FNA needle will be compared to the standard full thickness gastric biopsy which is routinely obtained in our institution during the surgical placement of the gastric stimulator.
1 secondary outcome
Safety of EUS FNA of gastric wall ( wither perforation or tear developed after the procedure)
Time frame: within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Derived from this study: PubMed 26318833Othman MO, Davis B, Saroseik I, Torabi A, McCallum RW. EUS-guided FNA biopsy of the muscularis propria of the antrum in patients with gastroparesis is feasible and safe. Gastrointest Endosc. 2016 Feb;83(2):327-33. doi: 10.1016/j.gie.2015.06.056. Epub 2015 Aug 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed O Othman, MD principal investigator
Texas Tech University Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA) in people with Idiopathic Gastroparesis and Diabetic Gastroparesis, run by Texas Tech University Health Sciences Center, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability of EUS FNA needle to obtain gastric smooth muscle tissue (time frame: During the procedure ( 45 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916460, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.