Endoscopic Stenting Techniques for Gastric Outlet Obstruction

Not currently recruiting at 14 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to assist individuals with gastric outlet obstruction (GOO), a condition where cancer blocks food from leaving the stomach and cannot be surgically removed. Researchers compare two less invasive techniques: one uses a lumen-apposing metal stent to create a new pathway between the stomach and small intestine, while the other places a self-expandable metal stent directly in the blocked part of the stomach. This trial suits those with cancer-caused GOO who cannot eat solid food and for whom surgery is not an option. As an unphased trial, it offers patients the chance to explore innovative treatments that might enhance their quality of life.

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.

What prior data suggests that these endoscopic stenting techniques are safe for treating gastric outlet obstruction?

Research shows that both types of stents used in this study are generally well-tolerated by patients with gastric outlet obstruction (GOO).

For the lumen-apposing metal stent (LAMS), studies have found a low risk of complications. Its design ensures it stays securely in place, preventing movement or blockages. Some studies have mentioned minor issues like bleeding, but these are uncommon.

For the self-expandable metal stent (SEMS), research indicates it is safe and effective for treating GOO. Many patients have experienced symptom improvement. Serious problems are rare, although some patients may experience stent blockage over time.

Overall, past studies have shown good safety for both stents, with only a few mild side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these endoscopic stenting techniques for gastric outlet obstruction because they offer innovative ways to bypass a blockage in the stomach. The EUS-guided gastroenterostomy (EUS-GE) creates a direct connection between the stomach and the small intestine using a lumen-apposing metal stent, potentially allowing for more efficient food passage. This technique is unique because it bypasses the obstructed area completely. On the other hand, the Enteral Stenting (ES) technique uses a self-expandable metal stent to open up the blocked pathway, providing an alternative for patients who might not be candidates for surgery. These methods are less invasive than traditional surgical options, potentially offering quicker recovery times and fewer complications.

What evidence suggests that these endoscopic stenting techniques are effective for gastric outlet obstruction?

This trial will compare two stenting techniques for treating gastric outlet obstruction (GOO). One technique uses a lumen-apposing metal stent, which effectively creates a stable, long-lasting connection between the stomach and small intestine, improving food passage. Research indicates that these stents are durable and can significantly relieve symptoms like nausea and vomiting.

The other technique uses a self-expandable metal stent. Evidence supports its effectiveness in opening the blocked area in the stomach, facilitating food passage. Patients have shown improvements in eating and reduced symptoms. Although there is a risk of the stent moving from its original position, it remains a safe and effective option for providing relief in GOO. ^{1 2 6 7 8}

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

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]

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 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 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]

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 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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6102456/

Current uses and outcomes of lumen-apposing metal stents Abstract. The lumen-apposing metal stent (LAMS) is one of the revolutionary devices recently developed for gastrointestinal endoscopy.

2. mdpi.com mdpi.com/2075-4418/13/21/3308

The Role of Luminal Apposing Metal Stents on ... The present paper reviews procedural techniques and clinical outcomes of EUS-GE in the context of both malignant and benign GOOs.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1590865823002220

EUS-guided gastroenterostomy using a novel ... EUS-guided gastroenterostomy using a novel electrocautery lumen apposing metal stent for treatment of gastric outlet obstruction (with video). Author links ...

4. tigejournal.org tigejournal.org/article/S1096-2883(19)30069-5/fulltext

Endoscopic ultrasonography-guided gastroenterostomy ... Durability and long-term outcomes of direct EUS-guided gastroenterostomy using lumen-apposing metal stents for gastric outlet obstruction. Endosc Int Open ...

5. e-ce.org e-ce.org/journal/view.php?number=7141

De-novo Gastrointestinal Anastomosis with Lumen ... Abstract. Gastric outlet obstruction, afferent or efferent limb obstruction, and biliary obstruction among patients with altered anatomy ...

6. gutnliver.org gutnliver.org/journal/view.html?pn=myread&uid=2276&vmd=Full

The Efficacy and Safety of Endoscopic Ultrasound-Guided ... Prospective multicenter international study on the outcomes of a newly developed self-approximating lumen-apposing metallic stent for drainage ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1424390325006258?dgcid=rss_sd_all

Early versus Delayed Removal of Lumen Apposing Metal ... Adverse events such as bleeding, buried stent in the late removal (> 4 weeks after deployment) were compared with those in the early removal ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11466529/

Outcomes of lumen apposing metal stent placement in ... However, data are limited on outcomes following LAMS placement in SAA. ... Use of lumen apposing metal stents in patients with altered gastrointestinal anatomy.