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
- Diseases
- Pancreatic cancer
- 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
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
| CHU Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Hôpital Haut Lévêque Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Hôpital Estaing Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Hôpital François Mitterrand Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CHU Lille - Hôpital Claude Huriez Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hopital Claude Huriez Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| CHU Dupuytren 1 Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital de la Croix Rousse Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital Saint Eloi Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Hôpitaux de Brabois Coordinator of this site? Confirm its status | Nancy | France | Unknown status |
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Hôpital Beaujon Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Cochin Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Ambroise Paré Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital de la Pitié-Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Charles Nicolle Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| CHU Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| Hopital Rangueil Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| Hôpital Paul-Brousse Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.