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)
R0 resection rate (clear margin > 1 mm) — day of surgery Proportion of randomized patients with R0 margins. R0 defined as clear margin \> 1 mm; R1 as ≤ 1 mm using standardized pathology protocol with central review.
Trial sites (23)
Facility
City
Region
Status
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
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.
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