Transpyloric Stenting for Gastroparesis

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Disqualifiers: GI surgeries, Malignancy, Cirrhosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if placing a special device in the stomach can help patients with severe stomach issues who don't respond to usual treatments. The device keeps the stomach opening clear to improve symptoms. If successful, it may indicate that a more permanent procedure could also work.

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 data supports the effectiveness of the treatment Transpyloric stent for gastroparesis?

Research shows that placing a transpyloric stent can help improve symptoms in patients with gastroparesis who do not respond to standard treatments. This approach is part of innovative endoscopic therapies being explored for managing this condition. ^{1 2 3 4 5}

Is transpyloric stenting generally safe for humans?

Transpyloric stenting can improve symptoms in gastroparesis, but it may have risks like stent migration, reflux, perforation, bleeding, and new strictures (narrowing of the passage) due to tissue growth. Temporary stents may reduce these risks, but complications can still occur. ^{1 2 6 7 8}

How does transpyloric stenting differ from other treatments for gastroparesis?

Transpyloric stenting is unique because it involves placing a stent (a small tube) to keep the pylorus (the opening from the stomach to the small intestine) open, which can help improve symptoms in patients who do not respond to standard treatments. This approach is different from medications or surgeries because it directly targets the pylorus to aid in gastric emptying. ^{1 2 3 6 9}

Research Team

Eligibility Criteria

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.

I am over 18 with gastroparesis not improved by standard treatments or cannot use them due to allergies.

Exclusion Criteria

I have cirrhosis.

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

I have cancer in my stomach or esophagus.

Trial Timeline

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

Treatment Details

Interventions

• Transpyloric stent (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.

Participant Groups

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+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Refractory gastroparesis can be successfully managed with endoscopic transpyloric stent placement and fixation (with video). [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Transpyloric feeding tube placement in critically ill patients using electromyogram and erythromycin infusion. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Influence of intrapyloric botulinum toxin injection on gastric emptying and meal-related symptoms in gastroparesis patients. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

Endoscopic Approaches to Gastroparesis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Surgical Management for Gastroparesis. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Therapeutic effect of a temporary transpyloric stent in refractory post-surgical gastroparesis: a case report. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

A Nonsurgical Method for the Placement of Transpyloric (Nasoenteric) Feeding Tubes Using Fluoroscopic Guidance in Dogs. [2019]

8. United States 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. [2017]

9. United States pubmed.ncbi.nlm.nih.gov

Stent Placement for the Treatment of Gastroparesis. [2019]