Superior Mesenteric Artery First Versus Standard Approach in Pancreaticoduodenectomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
"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 criteria
Qualifiers
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)
Disqualifiers
Pancreatic adenocarcinoma defined as "borderline" with arterial contact, locally advanced, non-resectable, or metastatic.
Major non-controlled infection
Major comorbidity that may preclude the surgery
Severe liver failure
Trial design
Treatments tested in this trial
- 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov