EUS-Guided Gastroenterostomy for Gastrointestinal Cancer

(INTERCEPT Trial)

Recruiting at 4 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

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled trial is to investigate the effectiveness and safety of Prophylactic EUS-gastroenterostomy (ProEUS-GE) as a preventative approach for malignant gastric outlet obstruction (MGOO) in men and women aged 18 years or older diagnosed with periampullary cancer. The main question this study aims to answer is can ProEUS-GE effectively prevent the occurrence of MGOO in patients with periampullary cancer? Patients will be randomly assigned to one of two groups: Group 1 (ERCP alone) or Group 2 (ERCP + ProEUS-GE). The study will compare the outcomes between these groups to determine the effectiveness of ProEUS-GE in preventing MGOO. Researchers will compare Group 1 (ERCP alone) with Group 2 (ERCP + ProEUS-GE) to see if the addition of ProEUS-GE leads to a reduced occurrence of MGOO in patients with periampullary cancer. The primary endpoint is the rate of malignant gastric outlet obstruction.

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 data supports the effectiveness of the treatment Prophylactic 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 stomach's exit. Studies indicate that EUS-GE can reduce the need for additional procedures compared to traditional stenting methods. ^{1 2 3 4 5}

Is EUS-guided gastroenterostomy safe for humans?

EUS-guided gastroenterostomy (EUS-GE) is generally considered safe, with serious side effects occurring in about 5.61% of cases. These side effects can include peritonitis (inflammation of the abdominal lining), perforation (a hole in the stomach or intestines), bleeding, and abdominal pain. ^{1 3 4 6 7}

How is the treatment EUS-guided gastroenterostomy different from other treatments for gastrointestinal cancer?

EUS-guided gastroenterostomy is a novel treatment that uses endoscopic ultrasonography (a type of imaging using sound waves) to create a new connection between the stomach and the small intestine, helping to relieve blockages caused by cancer. This approach is unique because it is minimally invasive and can be an alternative to traditional surgical methods or stent placements, potentially reducing the need for further interventions. ^{1 2 3 4 8}

Eligibility Criteria

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.

I am younger than 18 or older than 85.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

EUS-guided gastroenterostomy: Initial experience in a brazilian tertiary center. [2020]

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

EUS-guided gastroenterostomy versus enteral stent placement for palliation of malignant gastric outlet obstruction. [2020]

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

EUS-guided gastroenterostomy: a multicenter study comparing the direct and balloon-assisted techniques. [2018]

4. Netherlands 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. [2023]

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

Optimizing outcomes for EUS-guided gastroenterostomy: results of a Standardized Clinical Assessment and Management Plan (with video). [2022]

6. Germany 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. [2020]

7. England pubmed.ncbi.nlm.nih.gov

EUS-guided gastroenterostomy for gastric outlet obstruction: a comprehensive meta-analysis. [2023]

8. United States 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. [2023]