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Official title Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers
ClinicalTrials.gov ID: NCT05994521
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- (all of the following):
- Radiological diagnosis of a periampullary cancer that is precluded from upfront surgical resection of curative intent due to advanced tumor stage...
- Elevated liver function tests requiring ERCP without evidence of MGOO of significant gastroparesis (see exclusion criterion #3 and #4)
- ECOG 0 or 1
- ASA\<4
You likely can't join if
- (any of the following):
- Patient with clinical and radiological evidence of malignant gastric outlet obstruction defined as Gastric Outlet Obstruction Scoring System (GOOSS)...
- Gastroparesis with a Gastroparesis Cardinal Symptom Index (GCSI) of \>2. Gastroparesis is defined as having symptoms of MGOO without radiological...
- Uncorrectable coagulopathy and/or thrombocytopenia
- Age \< 18 or ≥ 85
- Evidence of peritoneal carcinomatosisAscites
See the full eligibility criteria
- (all of the following):
- 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...
- Elevated liver function tests requiring ERCP without evidence of MGOO of significant gastroparesis (see exclusion criterion #3 and #4)
- ECOG 0 or 1
- ASA\<4
- Provision of informed consent
- (any of the following):
- 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...
- 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.
- Uncorrectable coagulopathy and/or thrombocytopenia
- Age \< 18 or ≥ 85
- Evidence of peritoneal carcinomatosisAscites
- Liver metastasis \> 30% of the liver volume
- Portal hypertension with gastroesophageal varices and/or ascites
- Surgically altered upper gastrointestinal anatomy
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Canada
- Toronto, Canada
- Paris, France
- Hyderabad, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Canada; Toronto, Canada; Paris, France; Hyderabad, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.