Preventing gastric outlet obstruction in patients with advanced periampullary cancer
Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers: a Multicenter Randomized Controlled Trial
This study is testing if a new procedure called ProEUS-GE can help prevent stomach blockages in people with advanced periampullary cancer compared to just using ERCP alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 5 sites (Montreal and 4 other locations) |
| Trial ID | NCT05994521 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of prophylactic EUS-guided gastroenterostomy (ProEUS-GE) in preventing malignant gastric outlet obstruction (MGOO) in patients diagnosed with advanced periampullary cancer. Participants will be randomly assigned to receive either ERCP alone or ERCP combined with ProEUS-GE. The study aims to determine if the addition of ProEUS-GE reduces the occurrence of MGOO compared to ERCP alone. The primary endpoint is the rate of gastric outlet obstruction, and the trial will be conducted at multiple centers with experienced endoscopists.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a radiological diagnosis of advanced periampullary cancer who are not eligible for surgical resection.
Not a fit: Patients with existing malignant gastric outlet obstruction or significant gastroparesis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of gastric outlet obstruction in patients with advanced periampullary cancer, improving their quality of life.
How similar studies have performed: While the approach of using ProEUS-GE is innovative, similar studies have shown promise in managing gastric outlet obstruction in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (all of the following): 1. Radiological diagnosis of a periampullary cancer that is precluded from upfront surgical resection of curative intent due to advanced tumor stage. These include locally advanced or metastatic cancers of the pancreatic head, distal bile duct, duodenum, or ampulla. cancers. 2. Elevated liver function tests requiring ERCP without evidence of MGOO of significant gastroparesis (see exclusion criterion #3 and #4) 3. ECOG 0 or 1 4. ASA\<4 5. Provision of informed consent Exclusion Criteria (any of the following): 1. Patient with clinical and radiological evidence of malignant gastric outlet obstruction defined as Gastric Outlet Obstruction Scoring System (GOOSS) of \< 3 with radiological and/or endoscopic evidence of a mechanical obstruction from a gastric or duodenal stricture. GOOSS is a validated tool for assessing MGOO and is scored based on the diet tolerated by the patient: 0 for no oral intake, 1 for liquids only, 2 for soft diet, and 3 for low residue or full diet. 2. Gastroparesis with a Gastroparesis Cardinal Symptom Index (GCSI) of \>2. Gastroparesis is defined as having symptoms of MGOO without radiological and/or endoscopic evidence of mechanical obstruction. 3. Uncorrectable coagulopathy and/or thrombocytopenia 4. Age \< 18 or ≥ 85 5. Evidence of peritoneal carcinomatosisAscites 6. Liver metastasis \> 30% of the liver volume 7. Portal hypertension with gastroesophageal varices and/or ascites 8. Surgically altered upper gastrointestinal anatomy
Where this trial is running
Montreal and 4 other locations
- Jewish General Hospital — Montreal, Canada (Not_yet_recruiting)
- McGill University Health Center — Montreal, Canada (Recruiting)
- St-Michael's Hospital (SMH) — Toronto, Canada (Not_yet_recruiting)
- Hôpital Privé des Peupliers — Paris, France (Not_yet_recruiting)
- Asian Institute of Gastroenterology — Hyderabad, India (Not_yet_recruiting)
Study contacts
- Study coordinator: Yen-I Chen, MD
- Email: yen-i.chen@mgcill.com
- Phone: (514) 934-1934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.