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Clinical Trials in France / NCT07547033
Starting soon Not applicable

Superior Mesenteric Artery First Versus Standard Approach in Pancreaticoduodenectomy

NCT07547033 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-04-23

Condition(s) studied

Pancreatic AdenocarcinomaPancreatic Head Cancer

Investigational drug(s) / intervention(s)

SMA-first pancreaticoduodenectomy using either right posterior or anterior approach. SMA identified and isolated with peri-adventitial dissection before any irreversible section.Conventional pancreaticoduodenectomy without prior isolation of the SMA; antero-posterior approach of the uncinate process after pancreatic section.

SMA-first pancreaticoduodenectomy using either right posterior or anterior approach. SMA identified and isolated with peri-adventitial dissection before any irreversible section.: Before any irreversible gesture, the surgeon identifies and isolates the superior mesenteric artery and dissects nerve plexus and nodes on the right side up to the SMA origin (right posterior or anterior approach).

Conventional pancreaticoduodenectomy without prior isolation of the SMA; antero-posterior approach of the uncinate process after pancreatic section.: Conventional pancreaticoduodenectomy without prior isolation of the SMA; antero-posterior approach of the uncinate process after pancreatic section.

Study summary

"Pancreatic cancer, especially pancreatic ductal adenocarcinoma, is one of the most serious and deadly cancers. Its outlook is very poor, with fewer than 10% of patients surviving five years after diagnosis. This is largely because the disease is often discovered at a late stage and because it frequently comes back even after surgery.

When the tumor is located in the head of the pancreas, the only treatment that can potentially cure the disease is a major operation called a pancreaticoduodenectomy, also known as the Whipple procedure. This surgery is now safely performed in specialized hospitals, but it remains complex and carries a high risk of complications. Importantly, even after surgery, cancer cells often remain, leading to a high rate of local recurrence.

A newer surgical technique, known as the "artery-first" approach, changes the order of the operation. By carefully exposing a major blood vessel near the pancreas at the beginning of the surgery, surgeons can better assess whether the tumor can be completely removed and can improve the precision of the operation.

This research protocol aims to compare this artery-first technique with the standard surgical approach. The goal is to determine whether starting the operation by addressing the artery allows for more complete tumor removal and reduces the risk of cancer coming back in patients with pancreatic cancer of the head of the pancreas."

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Primary resectable or borderline with isolated veinous contact pancreatic adenocarcinoma (according to the NCCN classification and international consensual definition of Isaji 2018): resectability is evaluated on arterial-phase and portal-phase IV contrast-enhanced multislice CT scan of the pancreas (slice thickness: 2.5 mm), and assessed in a multidisciplinary staff meeting including at least one radiologist and one expert surgeon. 2. CT-scan of the thorax and abdomen confirming non-metastatic PAC at least 45 days before inclusion 3. MRI of the liver without metastasis performed maximum one month before inclusion 4. CA 19.9 (carbohydrate antigen) level ≤ 500 U/mL at the time of inclusion (in absence of cholestasis or biliary drainage) 5. Age 18 or over 6. Grade 0 or 1 Performans Status (ECOG) 7. Normal renal and liver function at the time of inclusion (According to Cockroft and Gault's equation Glomerular Function Rate \> 50ml/min/m2; Prothrombin Time \> 70%) 8. Absolute neutrophil count \> 1,500/mm3, platelet count \> 100,000/mm3, haemoglobin level \> 10 g/dl (transfusions are authorized) at time of inclusion 9. Adequate contraception on fertile women 10. "Women of childbearing potential (defined as under 50 years of age and without a history of hysterectomy or tubal ligation) must not self-report being pregnant on the day of inclusion." 11. Patient who provides a signed written informed consent form 12. Patient having the rights to French social insurance Exclusion Criteria: 1. Pancreatic adenocarcinoma defined as "borderline" with arterial contact, locally advanced, non-resectable, or metastatic. 2. Surgical or anesthesiologic contra-indications: Non-controlled congestive heart failure - non-treated angina - recent myocardial infarction (in the previous year) - non-controlled AHT (SBP \>160 mm or DBP \> 100 mm, despite optimal drug treatment), long QT 3. Major non-controlled infection 4. Major comorbidity that may preclude the surgery 5. Severe liver failure 6. Any medical, psychological, or social situation that (in the investigator's opinion) could limit (i) the patient's compliance with the protocol or (ii) the ability to obtain or interpret data 7. Pregnant or breastfeeding women and women of childbearing age not using effective means of contraception 8. Curatorship or guardianship or patient placed under judicial protection 9. Participation in other interventional research type 1, clinical investigation or clinical trial during the study Secondary exclusion criterion (during surgery): 1. Evaluation of abdominal cavity, presenting infra-radiologic metastasis 2. Positive tumoral invasion at frozen section after picking on the inter-aortic lymph nodes performed before any irrevocable organ section. 3. Anasthaesiologic complication (induction allergy or unprevisible heart disease at induction) 4. For fertile women: serological pregnancy test positive before surgery

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
CHU Amiens Amiens France
CHU Angers Angers France
CHU Besançon Besançon France
Hôpital Haut Lévêque Bordeaux France
Hôpital Estaing Clermont-Ferrand France
Hôpital François Mitterrand Dijon France
CHU Lille - Hôpital Claude Huriez Lille France
Hôpital Claude Huriez Lille France
CHU Dupuytren 1 Limoges France
Centre Léon Bérard Lyon France
Hôpital de la Croix-Rousse Lyon France
Hôpital Saint Eloi Montpellier France
Hôpitaux de Brabois Nancy France
Chu Nantes Nantes France
Hôpital Ambroise Paré Paris France
Hôpital Beaujon Paris France
Hôpital Cochin Paris France
Hôpital de la Pitié Salpêtrière Paris France
Hôpital Charles-Nicolle Rouen France
CHU Strasbourg Strasbourg France
Hôpital Rangueil Toulouse France
Hôpital Paul Brousse Villejuif France
Institut Gustave Roussy Villejuif France

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07547033 on ClinicalTrials.gov ↗ ← All trials in France