Superior Mesenteric Artery First Versus Standard Approach in Pancreaticoduodenectomy

Korábbi kezelés

• Major comorbidity that may preclude the surgery
• Participation in other interventional research type 1, clinical investigation or clinical trial during the study
  • Secondary exclusion criterion (during surgery):
• For fertile women: serological pregnancy test positive before surgery

Más betegség

• Major non-controlled infection
• Severe liver failure
• Anasthaesiologic complication (induction allergy or unprevisible heart disease at induction)

Laborértékek

• 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

Életkor

• Pregnant or breastfeeding women and women of childbearing age not using effective means of contraception

Egyéb

• Pancreatic adenocarcinoma defined as "borderline" with arterial contact, locally advanced, non-resectable, or metastatic.
• 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
• Curatorship or guardianship or patient placed under judicial protection
• Evaluation of abdominal cavity, presenting infra-radiologic metastasis
• Positive tumoral invasion at frozen section after picking on the inter-aortic lymph nodes performed before any irrevocable organ section.

• 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.
• CT-scan of the thorax and abdomen confirming non-metastatic PAC at least 45 days before inclusion
• MRI of the liver without metastasis performed maximum one month before inclusion
• CA 19.9 (carbohydrate antigen) level ≤ 500 U/mL at the time of inclusion (in absence of cholestasis or biliary drainage)
• Age 18 or over
• Grade 0 or 1 Performans Status (ECOG)
• 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%)
• Absolute neutrophil count > 1,500/mm3, platelet count > 100,000/mm3, haemoglobin level > 10 g/dl (transfusions are authorized) at time of inclusion
• Adequate contraception on fertile women
• "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."
• Patient who provides a signed written informed consent form
• Patient having the rights to French social insurance