"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."
"Pancreatic ductal adenocarcinoma (PDAC) is projected to become the second leading cause of cancer death in the United States and Europe by 2030. It remains the worst prognostic gastrointestinal cancer, with a 7-9% five-year overall survival (OS) rate. The majority of patients are diagnosed at an advanced stage, i.e., locally advanced (30%) or metastatic (50%), and more than 60% of the operated patients relapse within 3 years after surgery. Pancreaticoduodenectomy: standard approach Pancreaticoduodenectomy (PD) is the only potentially curative technique for PDAC of the pancreatic head. The procedure, commonly named the Whipple procedure, was described in 1935 when O.Whipple reported the previously modified technique by A.Codinivillan and W.Keusch. In its current form, the Whipple procedure owes its evolution to many physicians and surgeons' groundbreaking and innovative work. The procedure is now performed with an acceptable mortality rate of \< 4% in expert centers and and nevertheless 30% morbidity. Pancreaticoduodenectomy: SMA first approach, peri-adventitial dissection Whipple procedure with mesenteric first approach is a technique described and validated in surgery for pancreatic adenocarcinoma. This technique, which involves dissecting the peri-adventitial tissues of the superior mesenteric artery, has been reported mainly in borderline or locally advanced tumors of the head of the pancreas, to control the artery and improve the quality of the resection. This technique allows exposure of the right hemicircumference of the artery and clearance of the origin of the celiac trunk before sectioning the key elements of the duodenopancreatectomy cephalic. Six surgical approaches that can be considered as "artery first" have been reported by Sanjay et al. Two approaches to avoid technical biases in SMA dissection and arterial margins will be considered: the right posterior approach and the anterior approach. Although PD is mature, the low R0 resection rate remains a major issue, and most patients will develop a local recurrence, as demonstrated by autopsy studies. The investigators hypothesise that the SMA first approach (SMA-PD) improves R0 resection margins compared to the standard procedure (ST-PD) during PD in patients with pancreatic head adenocarcinoma."
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
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.
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
...and 13 more locations
R0 resection rate (clear margin > 1 mm)
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.
Time frame: day of surgery
Disease-free survival (DFS)
Disease-free survival will be evaluated using CT scans performed during follow-up
Time frame: Up to 48 months after randomization
Overall survival (OS)
Death from any cause or last follow-up, whichever occurs first.
Time frame: Up to 48 months after randomization
Operative Blood Loss
Intraoperative blood loss measured in milliliters and perioperative transfusion requirements.
Time frame: During surgery
Operative Time
Duration of surgical procedure measured in minutes from incision to skin closure.
Time frame: During surgery
Postoperative Complications
Postoperative complications assessed using Clavien-Dindo classification and Comprehensive Complication Index (CCI).
Time frame: Up to 3 months after surgery
Postoperative Morbidity
Morbidity will be assessed by comparing the percentage distribution of postoperative complications between the two groups
Time frame: Up to 3 months after surgery
Health related quality of Life
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the Pancreatic Cancer Module 26 (QLQ-PAN26)
Time frame: At inclusion and 6 months after surgery
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