Transpyloric Stenting for Gastroparesis

Overseen By Kevin Liu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: GI surgeries, Malignancy, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for people with gastroparesis that hasn't improved with usual care, such as diet changes or medications. The study aims to determine if a transpyloric stent (a small tube placed in the stomach) can predict the effectiveness of another procedure, called GPOEM, for these patients. Participants will receive either the stent or a sham (placebo) procedure and will remain unaware of which one they received for a month. It is best suited for those with a confirmed diagnosis of gastroparesis who haven't found success with standard treatments. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for gastroparesis.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It focuses on patients whose gastroparesis is not responding to standard treatments, so you might continue your current meds unless told otherwise by the trial team.

What prior data suggests that transpyloric stenting is safe for gastroparesis?

Research has shown that transpyloric stents are generally safe for treating gastroparesis, a condition where the stomach empties too slowly. In one study, patients with diabetic gastroparesis experienced significant symptom relief after receiving a transpyloric stent. Another study involving 30 patients found that placing the stents was mostly successful, although some stents shifted out of place. Using stitches to secure the stents helped reduce this issue. Overall, the treatment appears well-tolerated, with some challenges in maintaining stent position. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the transpyloric stent for gastroparesis because it offers a novel approach by physically opening the pylorus, the gateway between the stomach and the small intestine, potentially improving gastric emptying more directly compared to medications that modify stomach motility. Unlike standard treatments that rely on drugs or dietary changes, the stent acts as a mechanical solution to alleviate symptoms by keeping the passage open without altering the body's chemistry. This minimally invasive option could provide faster relief from symptoms like nausea and vomiting, common in gastroparesis, and may have fewer side effects than drug therapies. The excitement comes from the possibility of providing a new, effective option for patients whose symptoms have been resistant to existing treatments.

What evidence suggests that transpyloric stenting is effective for refractory gastroparesis?

In this trial, participants will be randomized to receive either a transpyloric stent or a sham procedure for treating refractory gastroparesis. Research has shown that placing a stent through the pylorus (the opening from the stomach to the small intestine) can help treat stubborn cases of gastroparesis, a condition where the stomach can't empty properly. One study found that symptoms improved significantly after the stent was placed, especially in individuals with gastroparesis caused by diabetes. If symptoms improve with the stent, it might also indicate that another procedure called GPOEM could be effective. The stent procedure succeeds 98% of the time, although the stent can sometimes move from its original position. This occurs less often when the stents are secured in place. Overall, these findings suggest that this stent procedure can help relieve symptoms for people with difficult-to-treat gastroparesis. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with gastroparesis that hasn't improved with standard treatments or those who can't take them due to allergies. It's open to patients with diabetic, idiopathic, or post-surgical forms of the condition confirmed by a gastric emptying study. People can't join if they've had certain GI surgeries, cancer in the stomach area, are unstable for endoscopy procedures, have liver cirrhosis, are pregnant/breastfeeding, or have significant blood clotting issues.

Inclusion Criteria

I have gastroparesis due to diabetes, surgery, or an unknown cause.

I have been diagnosed with gastroparesis through a gastric emptying study.

Exclusion Criteria

I have cirrhosis.

I have cancer in my stomach or esophagus.

I have had stomach or intestine surgery that involved the pylorus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a transpyloric stent or sham procedure for treatment of refractory gastroparesis

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for clinical response and adverse events using GCSI scores and other measures

1-2 years

What Are the Treatments Tested in This Trial?

Interventions

• Transpyloric stent

Trial Overview

The study is testing whether placing a transpyloric stent (a type of tube) across the pylorus (the stomach's exit) predicts success for a later procedure called G-POEM in treating severe gastroparesis. Participants will be randomly assigned to receive either the actual stenting procedure or a sham (fake) procedure as part of this forward-looking research.

How Is the Trial Designed?

Group I: Transpyloric stent Active Control 1 Intervention

In this group, patient's will be randomized to receive a transpyloric stent for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.

Group II: Sham Placebo Group 1 Intervention

In this group, patient's will be randomized to sham for treatment of refractory gastroparesis. They will be blinded for one month after stent placement as to whether they received a stent or sham.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A case study demonstrated that a temporary self-expanding metallic stent (SEMC) significantly improved symptoms of refractory gastroparesis in a patient who had not responded to other treatments, indicating its efficacy.

After the stent was removed, the patient remained symptom-free for at least one year, suggesting that the SEMC provides a safe and effective long-term solution for managing post-surgical gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effect of a temporary transpyloric stent in refractory post-surgical gastroparesis: a case report. Liang, GG., Zhang, QK., Zhang, GX., et al.[2020]

Transpyloric stent (TPS) placement is a promising endoscopic treatment for patients with refractory gastroparesis, showing a clinical response in 75% of patients, particularly benefiting those with predominant symptoms of nausea and vomiting.

The procedure achieved a high technical success rate of 98%, and stent migration was less common (48%) when stents were anchored with sutures, indicating a feasible approach to improve symptoms and gastric emptying in difficult cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refractory gastroparesis can be successfully managed with endoscopic transpyloric stent placement and fixation (with video). Khashab, MA., Besharati, S., Ngamruengphong, S., et al.[2015]

In a study involving 156 attempts at feeding tube placement using a magnet-tipped device, only 60% achieved the transpyloric position, which is lower than previously reported success rates of 88%.

Despite the overall low success rate, the technique may still offer benefits by potentially reducing the need for more invasive procedures like endoscopy for feeding tube placement in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter, prospective study of the placement of transpyloric feeding tubes with assistance of a magnetic device. The Magnet-Guided Enteral Feeding Tube Study Group. Boivin, M., Levy, H., Hayes, J.[2017]

There are currently limited effective treatments for gastroparesis, a condition that causes delayed stomach emptying and can lead to significant health issues for patients.

Recent innovations in minimally invasive endoscopic therapies, such as botulinum toxin injections and gastric electrical stimulation, show promise in managing gastroparesis and may improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Approaches to Gastroparesis. Liu, K., Enke, T., Aadam, A.[2021]

In a study of 20 patients with gastroparesis, intrapyloric injection of botulinum toxin significantly improved the gastric emptying of solid foods, reducing the time it took for solids to leave the stomach from 204 minutes to 132 minutes.

The treatment also led to a notable decrease in meal-related symptoms, such as fullness and nausea, indicating that botulinum toxin can effectively alleviate discomfort associated with gastroparesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of intrapyloric botulinum toxin injection on gastric emptying and meal-related symptoms in gastroparesis patients. Arts, J., van Gool, S., Caenepeel, P., et al.[2010]

Prokinetic medications are the first-line treatment for gastroparesis, but some patients do not respond and may require endoscopic or surgical options, which can have unpredictable outcomes.

Disrupting the pylorus, particularly through procedures like transpyloric stenting, has shown to improve symptoms in patients with pylorospasm-related gastroparesis, helping to assess their response before considering more definitive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stent Placement for the Treatment of Gastroparesis. Brewer Gutierrez, OI., Khashab, MA.[2019]

Gastroparesis is a chronic condition that often requires interventions beyond conservative management, with options ranging from feeding tubes to major surgeries like pyloromyotomy and gastrectomy.

Current treatment algorithms and outcomes data suggest that while conservative measures are important, a significant number of patients may benefit from more invasive procedures to improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Management for Gastroparesis. Zihni, AM., Dunst, CM., Swanström, LL.[2019]

In a study of 39 critically ill patients, the combination of erythromycin infusion and electromyogram (EMG) guidance achieved an 80% initial success rate for transpyloric tube placement, significantly improving the process compared to traditional methods.

The average time for successful tube placement was only 7.8 minutes, demonstrating that this method is not only effective but also efficient for critically ill patients who often require rapid nutritional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transpyloric feeding tube placement in critically ill patients using electromyogram and erythromycin infusion. Levy, H., Hayes, J., Boivin, M., et al.[2019]

A new fluoroscopic technique for nonsurgical transpyloric tube feeding placement in dogs has been developed, allowing for effective nutritional support without the need for invasive surgery.

This method has been successfully used in both anesthetized and awake dogs with various health conditions, although it does carry some risks, such as bile leakage and potential tube movement complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nonsurgical Method for the Placement of Transpyloric (Nasoenteric) Feeding Tubes Using Fluoroscopic Guidance in Dogs. Wohl, JS., Hudson, JA., Larocca, TJ.[2019]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6391776/

Therapeutic effect of a temporary transpyloric stent in ...

It was reported that the symptoms of diabetic gastroparesis had been greatly improved by transpyloric stent placement. However, the use of ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0016510719313562

Tu2021 TRANSPYLORIC STENTING FOR REFRACTORY ...

Clinical improvement after transpyloric stenting may predict response to G-POEM for refractory gastroparesis, despite the high rate of stent migration.

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giejournal.org

giejournal.org/article/S0016-5107(20)32030-7/fulltext

Sa2015 TRANSPYLORIC STENTING IN REFRACTORY ...

Twenty-four patients underwent TPS prior to GPOEM, 15 (63%) with LAMS and 9 (37%) with SEMS. TPS was technically successful without any intra-procedural AEs.

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centerwatch.com

centerwatch.com/clinical-trials/listings/NCT04287647/transpyloric-stenting-as-a-predictor-for-g-poem-for-refractory-gastroparesis

Transpyloric Stenting As a Predictor for G-POEM ...

A subsequent study of 30 patients with refractory gastroparesis who underwent transpyloric stenting demonstrated high technical success of stent ...

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withpower.com

withpower.com/trial/phase-gastroparesis-4-2019-c4dbf

Transpyloric Stenting for Gastroparesis

The procedure achieved a high technical success rate of 98%, and stent migration was less common (48%) when stents were anchored with sutures, indicating a ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2949708623000821

Long-term outcomes (≥3 years) after gastric peroral ...

In conclusion, our meta-analysis found that G-POEM is a safe and clinically effective long-term treatment modality in patients with refractory gastroparesis.