EUS-Guided Gastroenterostomy for Gastrointestinal Cancer

(INTERCEPT Trial)

Recruiting at 5 trial locations

Overseen By Myriam Martel, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: MGOO, Gastroparesis, Coagulopathy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to prevent malignant gastric outlet obstruction (MGOO) in individuals with periampullary cancer, which affects areas near the pancreas. Researchers aim to determine if adding Prophylactic EUS-gastroenterostomy (ProEUS-GE) to standard ERCP treatment can prevent MGOO. Participants will be divided into two groups: one receiving only ERCP and the other receiving both ERCP and ProEUS-GE. The trial seeks participants with advanced periampullary cancer that cannot be treated with surgery, who require ERCP due to liver issues but do not already have MGOO. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future treatment options.

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 ProEUS-GE is safe for preventing MGOO?

Research has shown that EUS-guided gastroenterostomy (EUS-GE) is a promising method for treating gastric outlet obstruction (GOO), a blockage that prevents food from leaving the stomach. Studies have found that EUS-GE is generally well-tolerated, with most patients not experiencing serious side effects.

Although some studies have reported complications, these are usually rare and manageable. The main risks of EUS-GE are similar to those of other scope-based procedures, such as infections or bleeding, but these are uncommon.

Overall, early findings suggest that EUS-GE is safe for patients. However, more research is needed to confirm these results and ensure the procedure's long-term safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EUS-guided gastroenterostomy technique because it offers a proactive approach for managing malignant gastric outlet obstruction (MGOO) in gastrointestinal cancer patients. Unlike the traditional "wait-and-see" approach, which involves reactive endoscopic interventions only after obstruction is diagnosed, this method acts as a preventative measure. By creating a bypass before symptoms develop, it has the potential to reduce complications and improve patient quality of life.

What evidence suggests that ProEUS-GE is effective for preventing MGOO in periampullary cancer?

Research has shown that EUS-guided gastroenterostomy (EUS-GE) effectively treats blockages in the stomach area caused by tumors. This trial will compare two approaches: one group will receive ERCP with prophylactic EUS-GE, while the other will undergo ERCP alone. Studies indicate that EUS-GE is a promising method for managing these obstructions. Known for its safety, the treatment has yielded good results for patients. Although more research is needed, EUS-GE is considered a reliable option and could help prevent blockages in patients with certain types of cancer near the pancreas. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Adults with advanced periampullary cancer not eligible for immediate surgery due to the tumor stage. Participants must have abnormal liver tests needing ERCP but no current gastric outlet obstruction or severe gastroparesis, be in good physical condition (ECOG 0 or 1), and give informed consent.

Inclusion Criteria

ASA<4

My cancer near the bile duct area cannot be surgically removed due to its advanced stage.

Provision of informed consent

Exclusion Criteria

I have severe stomach paralysis symptoms.

I have had surgery on my upper digestive system.

My cancer has spread to the lining of my abdomen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ERCP with or without prophylactic EUS-guided gastroenterostomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and occurrence of gastric outlet obstruction

18 months

Regular follow-up visits as per study protocol

Long-term follow-up

Participants' nutritional status, adverse events, and quality of life are assessed

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Prophylactic EUS-guided Gastroenterostomy

Trial Overview

The trial is testing if adding Prophylactic EUS-gastroenterostomy (ProEUS-GE) to standard ERCP treatment can prevent malignant gastric outlet obstruction in patients with advanced periampullary cancer. It's a randomized study comparing two groups: one receiving just ERCP and the other both treatments.

How Is the Trial Designed?

Group I: ERCP + ProEUS-GE Experimental Treatment 1 Intervention

ERCP with prophylactic eus-guided gastroenterostomy

Group II: ERCP alone Active Control 1 Intervention

ERCP procedure alone and management of MGOO will be on a wait-and-see approach, using endoscopic interventions performed only if obstruction is clinically diagnosed

Prophylactic EUS-guided Gastroenterostomy is already approved in United States, European Union for the following indications:

Approved in United States as EUS-guided Gastroenterostomy for:

• Malignant gastric outlet obstruction (MGOO) in patients with periampullary cancer

Approved in European Union as EUS-guided Gastroenterostomy for:

• Palliation of malignant gastric outlet obstruction (MGOO)

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

Jewish General Hospital

Collaborator

Trials

144

Recruited

283,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Published Research Related to This Trial

EUS-guided gastroenterostomy (EUS-GE) is a safe and effective treatment for gastric outlet obstruction (GOO), achieving a high technical success rate of 94.2% with the direct technique and 90.9% with the balloon-assisted technique among 74 patients studied.

The direct technique for EUS-GE is preferred due to its significantly shorter procedure time (about 36 minutes) compared to the balloon-assisted method (about 90 minutes), while maintaining similar clinical success rates and adverse event rates between the two approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUS-guided gastroenterostomy: a multicenter study comparing the direct and balloon-assisted techniques. Chen, YI., Kunda, R., Storm, AC., et al.[2018]

Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) demonstrated a high immediate technical success rate of 92.9% and a clinical success rate of 90.1% in treating gastric outlet obstruction in a study of 199 patients.

The procedure was found to be relatively safe, with serious adverse events occurring in only 5.6% of cases, indicating that EUS-GE is a promising minimally invasive option for both benign and malignant gastric outlet obstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of EUS-guided gastroenterostomy for benign and malignant gastric outlet obstruction: a systematic review and meta-analysis. McCarty, TR., Garg, R., Thompson, CC., et al.[2020]

Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) shows a high technical success rate of 94.0% and a clinical success rate of 89.9% in treating gastric outlet obstruction, based on a meta-analysis of 26 studies involving 1493 patients.

EUS-GE has a lower rate of adverse events (13.1%) compared to surgical gastroenterostomy, making it a safer and effective minimally invasive option for patients with both benign and malignant gastric outlet obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUS-guided gastroenterostomy for gastric outlet obstruction: a comprehensive meta-analysis. Li, JS., Lin, K., Tang, J., et al.[2023]

In a study of 50 patients undergoing EUS-guided gastroenterostomy (EUS-GE) for malignant gastric outlet obstruction, the standardized clinical management plan resulted in a 100% technical success rate and a 92% clinical success rate, indicating high efficacy of the procedure.

The study reported low adverse events (4%) and an estimated mean obstruction-free survival of 217 days, suggesting that the standardized approach not only enhances safety but also improves patient outcomes in managing gastric outlet obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing outcomes for EUS-guided gastroenterostomy: results of a Standardized Clinical Assessment and Management Plan (with video). Abbas, A., Dolan, RD., Thompson, CC.[2022]

EUS-guided gastroenterostomy (EUS-GE) demonstrated a significantly lower rate of stent failure requiring repeat intervention (8.3%) compared to enteral stent placement (32.0%) in a study of 100 patients with malignant gastric outlet obstruction.

EUS-GE also achieved a higher initial clinical success rate (95.8%) compared to enteral stent placement (76.3%), suggesting it may be a more effective option for palliation in selected patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUS-guided gastroenterostomy versus enteral stent placement for palliation of malignant gastric outlet obstruction. Ge, PS., Young, JY., Dong, W., et al.[2020]

EUS-guided gastroenterostomy (EUS-GE) significantly improves quality of life (QoL) in patients with unresectable malignant gastric outlet obstruction, with a notable increase of 21.6 points in global health status scores after 30 days.

The procedure allows for rapid resumption of oral intake in 95.3% of patients within 48 hours and has a high clinical success rate of 83.3%, demonstrating its efficacy in alleviating symptoms and facilitating quicker hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective multicenter assessment of the impact of EUS-guided gastroenterostomy on patient quality of life in unresectable malignant gastric outlet obstruction. Garcia-Alonso, FJ., Chavarria, C., Subtil, JC., et al.[2023]

In a small study of 3 patients with malignant gastric outlet obstruction, EUS-guided gastroenterostomy (EUS-GE) achieved both technical and clinical success, allowing all patients to tolerate a soft diet after the procedure.

There were no adverse events reported, suggesting that EUS-GE is a safe and effective option for palliating gastric outlet obstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EUS-guided gastroenterostomy: Initial experience in a brazilian tertiary center. Oliveira, JF., Cordero, MAC., Lima, GRA., et al.[2020]

In a study involving 97 patients with malignant gastric outlet obstruction, endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) significantly reduced the need for reintervention within 6 months (4% in EUS-GE group vs. 29% in duodenal stent group), indicating its superior efficacy.

EUS-GE also resulted in longer stent patency and better patient-reported eating habits compared to duodenal stenting, suggesting it may be a preferred treatment option when available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic ultrasonography-guided gastroenterostomy versus uncovered duodenal metal stenting for unresectable malignant gastric outlet obstruction (DRA-GOO): a multicentre randomised controlled trial. Teoh, AYB., Lakhtakia, S., Tarantino, I., et al.[2023]

Citations

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withpower.com

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EUS-Guided Gastroenterostomy for Gastrointestinal Cancer

Research shows that EUS-guided gastroenterostomy (EUS-GE) is effective in managing malignant gastric outlet obstruction, a condition where a tumor blocks the ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11811553/

Endoscopic ultrasound-guided gastroenterostomy: a review

EUS-GE is a promising evolving technique for treating GOO, and ongoing studies are necessary to validate its use in both benign and malignant GOO.

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annalsgastro.gr

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Conclusion EUS-GE appears to be a viable approach for the treatment of GOO patients, for both malignant and benign diseases, with favorable ...

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Long-Term Outcomes of EUS-Guided Gastroenterostomy

Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is effective and safe in benign and malignant indications. However, there is a paucity of literature ...

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thelancet.com

thelancet.com/journals/langas/article/PIIS2468-1253(25)00209-2/abstract

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Endoscopic ultrasound-guided gastroenterostomy versus open surgical gastrojejunostomy: clinical outcomes and cost effectiveness analysis.

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The goal of this randomized controlled trial is to investigate the effectiveness and safety of Prophylactic EUS-gastroenterostomy (ProEUS-GE) as a ...

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sciencedirect.com/science/article/abs/pii/S0016510723024586

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Endoscopic or surgical gastroenterostomy for ... - Gut

Panel A shows the endoscopic ultrasound-guided gastroenterostomy approach, in which a lumen-apposing metal stent is placed into the jejunum from the gastric ...