Using endoscopic ultrasound to improve pancreatic cancer staging
Prospective Study of Preoperative Diagnostic Endoscopy for the Diagnosis of Occult Metastatic Lesions of Operable Pancreatic Cancer
This study is testing if using endoscopic ultrasound can help better determine the stage of pancreatic cancer by checking lymph nodes in patients who need surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | IHU Strasbourg Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT04899739 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the staging of pancreatic cancer by extending the use of endoscopic ultrasound (EUS) to evaluate lymph nodes beyond the surgical field. Patients with solid or cystic pancreatic tumors requiring surgery will undergo EUS to biopsy the main tumor and classify lymph nodes as benign or malignant based on ultrasound criteria. The study will also collect video data to develop an artificial intelligence tool for lesion detection. The goal is to improve the accuracy of lymph node staging, which is crucial for treatment planning.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with solid or cystic pancreatic tumors who are scheduled for curative surgery.
Not a fit: Patients with bleeding disorders, severe pulmonary conditions, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate staging of pancreatic cancer, potentially improving surgical outcomes and patient survival rates.
How similar studies have performed: While the use of EUS in pancreatic cancer is established, this specific approach to lymph node staging is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient over 18 years old 2. Patient with a solid or degenerated cystic tumor of the pancreas requiring curative surgery 3. Patient with a complete clinical examination performed 4. Patient with no contraindication to anesthesia, upper digestive endoscopy and pancreatic surgery 5. Patient able to receive and understand information relating to the study and give informed written consent 6. Patient affiliated to the French social security system Exclusion Criteria: 1. Patient presenting with bleeding disease with disorder hemostasis and coagulation (PT \<60%, TCA\> 40 s and platelets \<60,000 / mm3) 2. Patient on anticoagulant or antiaggregant treatment that cannot be temporarily interrupted 3. 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. 4. Pregnant or breastfeeding patient 5. Patient in exclusion period (determined by a previous study or in progress) 6. Patient under legal protection 7. Patient under guardianship or trusteeship
Where this trial is running
Strasbourg
- Service de Chirurgie Digestive et Endocrinienne — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Patrick Pessaux, MD — Unité de Chirurgie Hépato-biliaire et Pancréatique, NHC Strasbourg
- Study coordinator: Armelle TAKEDA, PhD
- Email: armelle.takeda@ihu-strasbourg.eu
- Phone: 0390413608
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.