Brief 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."

Conditions

• Pancreatic Adenocarcinoma
• Pancreatic Head Cancer

Intervention / Treatment

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

Primary Outcome Measures

• 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.

Countries

France

Locations and Investigators

• CHU Amiens, Amiens, France
  • Jean-Marc REGIMBEAU, MD PHD
• CHU Angers, Angers, France
  • Emilie LERMITE, MD PHD
• CHU Besançon, Besançon, France
  • Alexandre DOUSSOT, MD
• Hôpital Haut Lévêque, Bordeaux, France
  • Christophe LAURENT, MD PHD
• Hôpital Estaing, Clermont-Ferrand, France
  • Emmanuel BUC, Professor
• Hôpital François Mitterrand, Dijon, France
  • Jean-Baptiste Dr LEQUEU, Dr
• CHU Lille - Hôpital Claude Huriez, Lille, France
  • Stéphanie TRUANT, MD PHD
• Hôpital Claude Huriez, Lille, France
  • Julie VEZIANT, MD
• CHU Dupuytren 1, Limoges, France
  • Abdelkader TAIBI, Dr
• Centre Léon Bérard, Lyon, France
  • Aurélien DUPRE, MD PHD
• Hôpital de la Croix-Rousse, Lyon, France
  • Jean-Yves MABRUT, MD PHD
• Hôpital Saint Eloi, Montpellier, France
  • François-Régis SOUCHE, Dr
• Hôpitaux de Brabois, Nancy, France
  • Ahmet AYAV, MD PHD
• Chu Nantes, Nantes, France
  • Nicolas REGENET, MD PHD
• Hôpital Ambroise Paré, Paris, France
  • Renato LUPINACI, MD PHD
• Hôpital Beaujon, Paris, France
  • Alain SAUVANET, MD PHD
• Hôpital Cochin, Paris, France
  • Ugo MARCHESE, MD
• Hôpital de la Pitié Salpêtrière, Paris, France
  • Gaujoux Sébastien, MD PHD
• Hôpital Charles-Nicolle, Rouen, France
  • Lilian SCHWARZ, MD - PHD
• CHU Strasbourg, Strasbourg, France
  • Pietro ADDEO, MD PHD
• Hôpital Rangueil, Toulouse, France
  • Fabrice MUSCARI, MD PHD
• Hôpital Paul Brousse, Villejuif, France
  • Daniel Pietrasz, MD
• Institut Gustave Roussy, Villejuif, France
  • Maximiliano GELLI, MD