Fact CheckerSign in

NCT07547033Not yet recruiting

Superior Mesenteric Artery First Versus Standard Approach in Pancreaticoduodenectomy

Source: ClinicalTrials.gov · Last updated 23 Apr 2026

Brief summary (registry, in English)

"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."

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
26 Feb 2026
Start date
1 Sept 2026
Primary completion date
1 Sept 2030
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT07547033

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From 1 Sept 2026 to the primary completion date, 1 Sept 2030
  • 23 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

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

Lab values

  • 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

Age

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

Other

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Amiens
Coordinator of this site? Confirm its status
AmiensFranceUnknown status
CHU Angers
Coordinator of this site? Confirm its status
AngersFranceUnknown status
CHU Besançon
Coordinator of this site? Confirm its status
BesançonFranceUnknown status
Hôpital Haut Lévêque
Coordinator of this site? Confirm its status
BordeauxFranceUnknown status
Hôpital Estaing
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status
Hôpital François Mitterrand
Coordinator of this site? Confirm its status
DijonFranceUnknown status
CHU Lille - Hôpital Claude Huriez
Coordinator of this site? Confirm its status
LilleFranceUnknown status
Hopital Claude Huriez
Coordinator of this site? Confirm its status
LilleFranceUnknown status
CHU Dupuytren 1
Coordinator of this site? Confirm its status
LimogesFranceUnknown status
Centre Leon Berard
Coordinator of this site? Confirm its status
LyonFranceUnknown status
Hôpital de la Croix Rousse
Coordinator of this site? Confirm its status
LyonFranceUnknown status
Hôpital Saint Eloi
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
Hôpitaux de Brabois
Coordinator of this site? Confirm its status
NancyFranceUnknown status
CHU Nantes
Coordinator of this site? Confirm its status
NantesFranceUnknown status
Hôpital Beaujon
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Hôpital Cochin
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Hôpital Ambroise Paré
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Hôpital de la Pitié-Salpêtrière
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Hôpital Charles Nicolle
Coordinator of this site? Confirm its status
RouenFranceUnknown status
CHU Strasbourg
Coordinator of this site? Confirm its status
StrasbourgFranceUnknown status
Hopital Rangueil
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
Hôpital Paul-Brousse
Coordinator of this site? Confirm its status
VillejuifFranceUnknown status
Institut Gustave Roussy
Coordinator of this site? Confirm its status
VillejuifFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.