NCT05994521 Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers
| NCT ID | NCT05994521 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Cancer Gi |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2024-04-09 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05994521 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Cancer Gi. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05994521 currently recruiting?
Yes, NCT05994521 is actively recruiting participants. Contact the research team at yen-i.chen@mgcill.com for enrollment information.
Where is the NCT05994521 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada, Toronto, Canada, Paris, France and 1 additional location.
Who is sponsoring the NCT05994521 clinical trial?
NCT05994521 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The trial plans to enroll 110 participants.
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