Intraoperative Endoscopic Ultrasound for Pancreatic Cancer (NCT04899739) | Clinical Trial Compass
CompletedNot Applicable
Intraoperative Endoscopic Ultrasound for Pancreatic Cancer
France33 participantsStarted 2021-12-05
Plain-language summary
Nowadays pancreatic cancer is one of the deadliest oncological pathologies. The only effective curative tool is the surgery. Before the intervention, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. In this study, the echoendoscopie will be extended to lymph node staging away from the surgical field in order to implement a simple classification of lymph nodes, based on non-invasive ultrasound criteria. This would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient over 18 years old
. Patient with a solid or degenerated cystic tumor of the pancreas requiring curative surgery
. Patient with a complete clinical examination performed
. Patient with no contraindication to anesthesia, upper digestive endoscopy and pancreatic surgery
. Patient able to receive and understand information relating to the study and give informed written consent
. Patient affiliated to the French social security system
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity)
Timeframe: 1 month
2
Rate of lymph nodes wrongly categorised by ultrasound endoscopy. (Specificity)
. Patient presenting with bleeding disease with disorder hemostasis and coagulation (PT \<60%, TCA\> 40 s and platelets \<60,000 / mm3)
. Patient on anticoagulant or antiaggregant treatment that cannot be temporarily interrupted
. Patient carrying a right-left shunt, a severe pulmonary arterial hypertension (high blood pressure pulmonary\> 90 mm Hg), uncontrolled systemic hypertension or suffering from respiratory distress syndrome.
. Pregnant or breastfeeding patient
. Patient in exclusion period (determined by a previous study or in progress)