AXIOS™ Stent for Gastric Outlet Obstruction

Recruiting at 13 trial locations

Overseen By Evelyne Ho, MPH, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must not be taking: Anticoagulants

Disqualifiers: Gastric cancer, Pregnancy, Ascites, others

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

Compensation: Varies

Number of Visits: 5

Duration: During the procedure

67 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the AXIOS™ Stent for treating gastric outlet obstruction?

Research shows that metal stents, like the AXIOS™ Stent, are effective in treating gastric outlet obstruction by helping to open blocked areas in the stomach. These stents have been used successfully in both benign and malignant cases, improving the ability to eat and digest food. ^{1 2 3 4 5}

Is the AXIOS Stent safe for use in humans?

The Hot AXIOS system, which includes a cautery-enhanced stent, has been studied for safety in procedures like draining pancreatic fluid collections and gallbladder issues. Research indicates it is generally safe for these uses, suggesting it may be safe for other conditions as well. ^{1 3 6 7 8}

How is the AXIOS™ Stent treatment different from other treatments for gastric outlet obstruction?

The AXIOS™ Stent with electrocautery-enhanced delivery is unique because it allows for a minimally invasive procedure using endoscopic ultrasound to create a bypass for obstructions, which can be particularly beneficial for patients who are not suitable for surgery. This approach contrasts with traditional surgical methods and other stent placements that may not use electrocautery or endoscopic ultrasound guidance. ^{1 4 5 9 10}

What is the purpose of this trial?

To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.

Research Team

Shayan Irani, MBBS, MD

Principal Investigator

Virginia Mason Medical Center

Eligibility Criteria

This trial is for individuals with gastric outlet obstruction or pyloric stenosis, which are conditions that block food from leaving the stomach. Participants must have symptoms due to a malignant tumor that cannot be removed by surgery.

Inclusion Criteria

GOOS of 0 or 1 (0 - no oral intake, 1 - liquids only)

Willing and able to comply with the study procedures or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study

The distance between the gastric lumen and jejunal lumen must be no more than 1.0 cm

Exclusion Criteria

Vessels located within 3.5-4 cm of the pathway from the device insertion location on the gastric wall to the device insertion location of the small bowel wall

Allergic to any of the device materials

Contraindications to use of electrical devices

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EUS-guided gastroenterostomy using the AXIOS lumen-apposing Metal Stent

During the procedure

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and technical success, including serious adverse events and stent patency

4 weeks

1 visit (in-person)

Extended Follow-up

Participants are monitored for clinical success and device deficiencies over time

12 months

3 visits (in-person) at 3, 6, and 12 months

Treatment Details

Interventions

• AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

Trial Overview The trial is testing the AXIOS(TM) Stent and Electrocautery Enhanced Delivery System. It aims to see if this method is safe and successful in creating a new pathway for food to bypass the blocked area in patients' stomachs.

Participant Groups

Group I: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System Experimental Treatment 1 Intervention

Patients who meet all the inclusion criteria and none of the exclusion criteria will have a EUS-guided gastroenterostomy (EUS-GE) using the AXIOS(TM) lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Findings from Research

Electrocautery lumen-apposing metal stents, like the bi-flanged SpaxusTM stent, represent a novel and effective treatment for gastric outlet obstruction, which can occur due to various benign or malignant conditions.

This case report highlights the successful use of endoscopic ultrasound-guided gastroenterostomy with the SpaxusTM stent, demonstrating its potential as a minimally invasive option for improving gastric emptying in patients with obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Ultrasound Gastro-Enteroanastomosis for Benign Gastric Outlet Obstruction due to Large Duodenal Diverticula. Auriemma, F., De Marco, A., Repici, A., et al.[2023]

Endoscopic self-expanded metal stents have a high success rate of 98.2% in treating gastric outlet obstruction, allowing most patients to resume eating liquid and normal foods within days after the procedure.

The procedure is considered safe, with a low complication rate (14.5% experiencing pain and 25.5% with bleeding), and it provides a mean survival time of approximately 139 days for patients, making it an effective micro-invasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Endoscopic self-expanded metal stent for gastric outlet obstruction:a ten-year experience]. Zhong, YS., Yao, LQ., Xu, MD., et al.[2019]

In a study involving 9 patients with malignant gastric outlet obstruction, metallic stent placement was successful on the first attempt for all patients, demonstrating high efficacy in alleviating obstructive symptoms.

The mean stent patency was 53.4 days, with no instances of stent migration or occlusion during a 3-month follow-up, indicating that metallic stents are a reliable option for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Malignant Gastric Outlet Obstruction with Expandable Metallic Stent Placement. Wang, ZY., Sun, LW., Wu, JL., et al.[2020]

Self-expanding metal stents (SEMS) were successfully inserted in 22 out of 23 patients with gastric outlet obstruction, with 45% of patients able to return to a normal diet, indicating their effectiveness in palliating this condition.

The study found no immediate complications from the stent insertion, although 27% of patients required reintervention due to issues like inadequate stent expansion and tumor ingrowth, highlighting the need for careful monitoring after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expandable metal stents for the palliation of malignant gastroduodenal obstruction. Razzaq, R., Laasch, HU., England, R., et al.[2019]

In a study of 29 patients with unresectable malignant gastric outlet obstruction, the use of a long delivery system for a self-expanding coil stent was successful in 89.7% of cases, demonstrating its efficacy in palliative care.

After stent insertion, 96.3% of patients experienced symptomatic improvement, particularly in food ingestion and vomiting, indicating a significant enhancement in quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-expanding coil stent with a long delivery system for palliation of unresectable malignant gastric outlet obstruction: a prospective study. Kim, JH., Yoo, BM., Lee, KJ., et al.[2004]

In a study of 260 patients with malignant gastric outlet obstruction, secondary gastroduodenal stent placement was found to be effective, achieving a technical success rate of 100% and a clinical success rate of 86.2%.

However, the procedure carries risks, with gastrointestinal perforation being the most significant complication, occurring in 13.8% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of secondary gastroduodenal self-expandable metallic stent placement by stent-in-stent technique for malignant gastric outlet obstruction. Sasaki, T., Isayama, H., Nakai, Y., et al.[2016]

The Hot AXIOS™ system for EUS-guided drainage showed a high technical success rate of 97.7% in 45 patients, indicating its effectiveness for managing pancreatic fluid collections, gallbladder drainage, and biliary drainage.

Clinical success was achieved in 86.4% of cases, with a relatively low adverse event rate of 11.4%, suggesting that this new lumen-apposing metal stent (LAMS) system is both safe and effective when used by experienced endoscopists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided transmural drainage by cautery-tipped lumen-apposing metal stent: exploring the possible indications. Anderloni, A., Leo, MD., Carrara, S., et al.[2022]

The Hot AXIOS system for EUS-guided drainage of pancreatic fluid collections (PFCs) demonstrated a high technical success rate of 100% and a clinical success rate of 93.3% in a study of 30 patients, indicating its efficacy in treating conditions like pancreatic pseudocysts and walled-off necrosis.

While the procedure was generally safe, with most complications being manageable, 46.7% of patients experienced PFC-associated infections, and the likelihood of achieving complete remission of PFCs within one month was significantly higher in patients with a history of pancreatitis more than six months prior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Chinese prospective multicenter cohort study evaluating EUS-guided drainage of pancreatic fluid collections using the Hot AXIOS system. Li, P., Zhang, Z., Wang, S., et al.[2023]

The AXIOS stent and electrocautery-enhanced delivery system can effectively create an enterocolostomy to bypass small bowel obstructions in patients with recurrent malignant bowel obstruction, providing a less invasive alternative to surgery.

In a case involving a 72-year-old patient unfit for surgery, this novel approach successfully resolved the obstruction, highlighting its potential as a safe and effective intervention for managing distressing symptoms in end-stage cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided creation of an enterocolostomy to relieve malignant bowel obstruction. Mir, A., Parekh, PJ., Shakhatreh, M., et al.[2020]

Fluoroscopically guided placement of uncovered metal stents for treating gastric outlet and duodenal obstructions was found to be 100% technically successful, with 12 out of 14 patients able to maintain oral intake for periods ranging from 7 to 270 days.

The procedure was deemed safe, with no immediate complications reported, although careful patient selection is necessary as some may not benefit from the stenting, particularly in benign cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of gastric outlet and duodenal obstructions with uncovered expandable metal stents. Huang, Q., Dai, DK., Qian, XJ., et al.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Endoscopic Ultrasound Gastro-Enteroanastomosis for Benign Gastric Outlet Obstruction due to Large Duodenal Diverticula. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[Endoscopic self-expanded metal stent for gastric outlet obstruction:a ten-year experience]. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

Management of Malignant Gastric Outlet Obstruction with Expandable Metallic Stent Placement. [2020]

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

Expandable metal stents for the palliation of malignant gastroduodenal obstruction. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Self-expanding coil stent with a long delivery system for palliation of unresectable malignant gastric outlet obstruction: a prospective study. [2004]

6. Australia pubmed.ncbi.nlm.nih.gov

Clinical outcomes of secondary gastroduodenal self-expandable metallic stent placement by stent-in-stent technique for malignant gastric outlet obstruction. [2016]

7. Greece pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided transmural drainage by cautery-tipped lumen-apposing metal stent: exploring the possible indications. [2022]

8. China pubmed.ncbi.nlm.nih.gov

A Chinese prospective multicenter cohort study evaluating EUS-guided drainage of pancreatic fluid collections using the Hot AXIOS system. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasound-guided creation of an enterocolostomy to relieve malignant bowel obstruction. [2020]

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

Treatment of gastric outlet and duodenal obstructions with uncovered expandable metal stents. [2019]