Endoscopic Stenting Techniques for Gastric Outlet Obstruction

Recruiting at 13 trial locations

Overseen By Lauren A Richardson, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Other GI strictures, Previous GI surgery, WHO score 4, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two less invasive treatments for patients with a blocked stomach due to cancer. One method uses ultrasound to create a new pathway between the stomach and small intestine, while the other uses a stent to keep the blocked area open. The goal is to see which method is safer and more effective.

Will I have to stop taking my current medications?

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.

Will I have to stop taking my current medications?

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.

Is the use of lumen-apposing metal stents (LAMS) generally safe for humans?

Lumen-apposing metal stents (LAMS) have been used in various procedures, and while they are generally considered safe, there have been reports of adverse events, especially in procedures like gallbladder drainage. It's important to discuss potential risks with your healthcare provider. ^{1 2 3 4 5}

Is the use of lumen-apposing metal stents (LAMS) generally safe for humans?

Lumen-apposing metal stents (LAMS) have been used in various procedures, such as treating benign gastrointestinal tract strictures and draining pancreatic fluid collections. While they are increasingly used, some studies indicate that there is limited data on their safety, especially in procedures like gallbladder drainage, suggesting that more research is needed to fully understand their safety profile. ^{1 2 3 4 6}

How is the treatment with Lumen-apposing metal stent (LAMS) and Self-expandable metal stent (SEMS) unique for gastric outlet obstruction?

The Lumen-apposing metal stent (LAMS) and Self-expandable metal stent (SEMS) are unique because they provide a minimally invasive option to relieve symptoms of gastric outlet obstruction, especially in patients who cannot undergo surgery. These stents expand within the body to open up blocked areas, offering effective palliation for those with inoperable conditions. ^{7 8 9 10 11}

How does the treatment with Lumen-apposing metal stent (LAMS) and Self-expandable metal stent (SEMS) differ from other treatments for gastric outlet obstruction?

The Lumen-apposing metal stent (LAMS) and Self-expandable metal stent (SEMS) are unique because they provide a minimally invasive option to relieve blockages in the stomach caused by cancer, offering effective symptom relief without the need for surgery. These stents expand on their own to open up the blocked area, making them a promising choice for patients who cannot undergo surgery. ^{7 8 9 10 11}

What data supports the effectiveness of the treatment for gastric outlet obstruction?

Research shows that self-expandable metal stents (SEMS) and lumen-apposing metal stents (LAMS) are effective in relieving symptoms of gastric outlet obstruction, especially when caused by cancer. These stents help open up blocked areas, allowing food to pass through more easily, and have shown high technical success in studies. ^{5 7 9 10 12}

What data supports the effectiveness of the treatment for gastric outlet obstruction?

Research shows that self-expandable metal stents (SEMS) and lumen-apposing metal stents (LAMS) are effective in relieving symptoms of gastric outlet obstruction, especially when caused by cancer. These stents help open up blocked areas, allowing food to pass through more easily, and have shown high success rates in studies. ^{5 7 9 10 12}

Who Is on the Research Team?

Mouen A Khashab, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Adults with malignant, unresectable gastric outlet obstruction and a GOOSS score of 0 or 1 can join. They must be able to undergo sedated endoscopy and fill out questionnaires. Excluded are those with severe clotting issues, complete obstruction, critical illness preventing endoscopy, bedridden status (WHO score of 4), resectable tumors, large ascites, pregnancy/breastfeeding, other GI strictures or prior related surgeries.

Inclusion Criteria

I have a cancer-caused blockage in my stomach that cannot be surgically removed.

Gastric outlet obstruction scoring system (GOOSS) score of 0 (no oral intake) or 1 (liquids only)

Exclusion Criteria

I have a large amount of fluid in my abdomen.

My cancer has spread to my stomach, duodenum, or near the ligament of Treitz.

I have had surgery on my stomach or the beginning of my small intestine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either EUS-guided gastroenterostomy or enteral stenting for palliation of malignant gastric outlet obstruction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for recurrence of gastric outlet obstruction and other outcomes

3 months

Multiple visits (in-person and virtual)

Long-term follow-up

Participants' diet toleration and quality of life are assessed using the GOOSS and SF-36 questionnaire

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Lumen-apposing metal stent
• Self-expandable metal stent

Trial Overview The trial compares two less invasive techniques for palliating gastric outlet obstruction: Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) versus enteral stenting (ES). It aims to determine which method is safer and more effective in providing relief from the symptoms caused by this condition.

How Is the Trial Designed?

Group I: EUS-guided gastroenterostomy (EUS-GE) Active Control 1 Intervention

In this technique, the gastric wall and its adjacent small intestine are punctured by a needle to make a connection between the stomach and small intestine. Then a lumen-apposing metal stent is deployed at the puncture site to keep the stomach-small intestine connection open.

Group II: Enteral Stenting (ES) Active Control 1 Intervention

In this technique, under endoscopic visualization, a guidewire will be advanced through the obstructed part of the stomach. Then an enteral self-expandable metal stent will be deployed under direct endoscopic visualization and fluoroscopic guidance.

Lumen-apposing metal stent is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Lumen-apposing metal stent for:

• Gastric outlet obstruction
• Biliary obstruction
• Gastrointestinal fistula

Approved in European Union as LAMS for:

• Gastric outlet obstruction
• Biliary obstruction
• Gastrointestinal fistula
• Walled-off necrosis

Approved in Canada as Lumen-apposing metal stent for:

• Gastric outlet obstruction
• Biliary obstruction

Approved in Japan as LAMS for:

• Gastric outlet obstruction
• Biliary obstruction
• Gastrointestinal fistula

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Boston Scientific Corporation

Industry 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

Published Research Related to This Trial

In a study of 29 patients with non-resectable malignant gastric outlet obstruction, self-expanding metal stents (SEMS) successfully relieved obstruction in all cases, allowing 23 patients to resume an oral diet.

The procedure had a low complication rate, with no procedure-related issues reported, and the median survival time post-stenting was 47 days, indicating that SEMS can provide effective palliative care for patients with advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Self-expanding metal stents as palliative treatment of a malign obstruction in the distal part of the ventricle or duodenum]. Olsen, E., Kiil, J., Petersen, JB.[2016]

Endoscopic placement of self-expandable metallic stents (SEMSs) is an effective method for providing short-term relief from gastric outlet obstruction in patients with recurrent gastric cancer after surgery, achieving a clinical success rate of 90% across 39 stents placed.

Despite a relatively high complication rate of 44%, including issues like perforations and restenoses, the procedure is feasible and offers a median stent patency of 10.7 weeks and median survival of 21.3 weeks, showing its utility in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-expandable metallic stent placement for malignant obstruction in patients with locally recurrent gastric cancer. Kim, J., Choi, IJ., Kim, CG., et al.[2021]

In a study of 35 patients undergoing EUS-guided gastrointestinal anastomosis with lumen-apposing metal stents (LAMS), the technical success rate was 80%, indicating that this technique is generally effective for creating anastomoses, particularly in cases of malignant gastric outlet obstruction.

The distance between the two lumina being connected was a significant predictor of technical success, with shorter distances (median of 9 mm) correlating with better outcomes, highlighting the importance of procedural conditions and the endoscopist's experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic gastrointestinal anastomoses with lumen-apposing metal stents: predictors of technical success. Wannhoff, A., Ruh, N., Meier, B., et al.[2021]

In a study of 62 patients with gastric outlet obstruction due to cancer, the WallFlex enteral stent demonstrated an 85% clinical success rate in alleviating symptoms, allowing for improved oral intake just one day after placement.

The procedure was relatively safe, with a complication rate of 17% within 30 days, indicating that the stent is an effective option for palliative care in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First data on the palliative treatment of patients with malignant gastric outlet obstruction using the WallFlex enteral stent: a retrospective multicenter study. van Hooft, J., Mutignani, M., Repici, A., et al.[2007]

Self-expandable metal stents (SEMS) were successfully placed in 92% of 36 patients with malignant gastric outlet or proximal small bowel obstructions, leading to clinical improvement in 75% of cases.

Despite their effectiveness, SEMS placement is associated with significant complications, including stent dysfunction in 36% of patients and biliary obstruction in 50%, suggesting that this procedure should be performed in experienced centers and on carefully selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliation of gastric outlet obstruction and proximal small bowel obstruction with self-expandable metal stents: a single center series. Mosler, P., Mergener, KD., Brandabur, JJ., et al.[2006]

The study involved 21 patients with benign gastrointestinal strictures, and the lumen-apposing metal stent (LAMS) demonstrated a 100% technical success rate, indicating it can be effectively placed in patients.

Short-term clinical success was achieved in 90.5% of cases, but long-term success was lower at 66.7%, with complications such as stent migration and ulceration occurring, suggesting the need for careful monitoring and further research on its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumen-apposing metal stents for benign gastrointestinal tract strictures: An international multicenter experience. Santos-Fernandez, J., Paiji, C., Shakhatreh, M., et al.[2020]

Lumen-apposing metal stents (LAMSs) are effective devices for endoscopic gastrointestinal interventions, initially designed for draining pancreatic pseudocysts and walled-off necrosis, but now also used for gallbladder drainage and creating gastroenterostomies.

The review highlights the favorable design features of LAMSs, such as their large inner diameter and unique shape, which enhance their effectiveness in forming anastomoses between the gut lumen and adjacent structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumen-apposing metal stents (with videos). Law, RJ., Chandrasekhara, V., Bhatt, A., et al.[2021]

The use of a self-approximating lumen-apposing metallic stent (LAMS) for draining pancreatic fluid collections was found to be 100% technically and clinically successful in a study of 59 patients, indicating its high efficacy.

The stent had a low rate of stent-related adverse events (6.8%), with only a small percentage of patients experiencing complications, demonstrating its safety for use in endoscopic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective multicenter international study on the outcomes of a newly developed self-approximating lumen-apposing metallic stent for drainage of pancreatic fluid collections and endoscopic necrosectomy. Teoh, AYB., Bapaye, A., Lakhtakia, S., et al.[2021]

The use of lumen-apposing metal stents (LAMS) in endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) shows a pooled adverse event (AE) rate of 12.7%, which is comparable to the 17.5% AE rate associated with traditional self-expanding metal stents (SEMSs).

The early adverse event rate for LAMS is 6.5%, while the delayed adverse event rate is 8.3%, indicating that LAMS can be a safe option for gallbladder drainage with minimal heterogeneity in the studies analyzed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events with lumen-apposing metal stents in endoscopic gallbladder drainage: A systematic review and meta-analysis. Mohan, BP., Asokkumar, R., Shakhatreh, M., et al.[2022]

In a study of 224 patients with malignant gastric outlet obstruction, self-expandable metal stents showed a high technical success rate of 99.6% and a clinical success rate of 80.4%, indicating their effectiveness in palliative care without immediate complications.

Combining uncovered stents with follow-up chemotherapy significantly improved stent patency rates, suggesting that this approach enhances the mechanical benefits of the stent while leveraging the therapeutic effects of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the ideal stent as initial intervention for malignant gastric outlet obstruction? Park, CI., Kim, JH., Lee, YC., et al.[2022]

The study involved 100 patients undergoing self-expanding metallic stent (SEMS) insertion for malignant gastric outlet obstruction, with a high technical success rate of 86.4%, indicating that SEMS is an effective palliative treatment option.

Successful stenting significantly improved patients' ability to eat and was associated with increased survival, highlighting the importance of stent placement in enhancing quality of life for patients with limited life expectancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assessment of radiologically inserted transoral and transgastric gastroduodenal stents to treat malignant gastric outlet obstruction. Miller, BHT., Griffiths, EA., Pursnani, KG., et al.[2017]

Citations

1. Denmark pubmed.ncbi.nlm.nih.gov

[Self-expanding metal stents as palliative treatment of a malign obstruction in the distal part of the ventricle or duodenum]. [2016]

2. Germany pubmed.ncbi.nlm.nih.gov

Self-expandable metallic stent placement for malignant obstruction in patients with locally recurrent gastric cancer. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic gastrointestinal anastomoses with lumen-apposing metal stents: predictors of technical success. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

First data on the palliative treatment of patients with malignant gastric outlet obstruction using the WallFlex enteral stent: a retrospective multicenter study. [2007]

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

Palliation of gastric outlet obstruction and proximal small bowel obstruction with self-expandable metal stents: a single center series. [2006]

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

Lumen-apposing metal stents for benign gastrointestinal tract strictures: An international multicenter experience. [2020]

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

Lumen-apposing metal stents (with videos). [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

Prospective multicenter international study on the outcomes of a newly developed self-approximating lumen-apposing metallic stent for drainage of pancreatic fluid collections and endoscopic necrosectomy. [2021]

9. China pubmed.ncbi.nlm.nih.gov

Adverse events with lumen-apposing metal stents in endoscopic gallbladder drainage: A systematic review and meta-analysis. [2022]

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

Use of lumen apposing metal stents in patients with altered gastrointestinal anatomy. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

What is the ideal stent as initial intervention for malignant gastric outlet obstruction? [2022]

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

An assessment of radiologically inserted transoral and transgastric gastroduodenal stents to treat malignant gastric outlet obstruction. [2017]