Actively Recruiting
Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2024-10-01
110
Participants Needed
5
Research Sites
172 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
J
Jewish General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Radiological diagnosis of periampullary cancer that cannot be treated with upfront surgery due to advanced tumor stage
- Elevated liver function tests requiring ERCP without significant gastric outlet obstruction or gastroparesis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- American Society of Anesthesiologists (ASA) classification less than 4
- Provided informed consent to participate in the study
You will not qualify if you...
- Evidence of malignant gastric outlet obstruction with a Gastric Outlet Obstruction Scoring System (GOOSS) score less than 3 and mechanical obstruction from gastric or duodenal stricture
- Gastroparesis with a Gastroparesis Cardinal Symptom Index (GCSI) score greater than 2
- Uncorrectable blood clotting problems or low platelet count
- Age under 18 or 85 years and older
- Presence of peritoneal carcinomatosis or ascites
- Liver metastases involving more than 30% of liver volume
- Portal hypertension with gastroesophageal varices or ascites
- Surgically altered upper gastrointestinal anatomy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Jewish General Hospital
Montreal, Canada
Not Yet Recruiting
2
McGill University Health Center
Montreal, Canada
Actively Recruiting
3
St-Michael's Hospital (SMH)
Toronto, Canada
Not Yet Recruiting
4
Hôpital Privé des Peupliers
Paris, France
Not Yet Recruiting
5
Asian Institute of Gastroenterology
Hyderabad, India
Not Yet Recruiting
Research Team
Y
Yen-I Chen, MD
CONTACT
M
Myriam Martel, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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