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Superior Mesenteric Artery First Versus Standard Approach in Pancreaticoduodenectomy

ConditionsPancreatic AdenocarcinomaPancreatic Head Cancer
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

This trial does not accept healthy volunteers

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

Design model

Parallel

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.

    Procedure/Surgery

    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.

    Procedure/Surgery

    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 groups
Group A: Standard arm (ST-PD)Active comparator 1 intervention
Group B: Experimental arm (SMA-PD)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Overall survival (OS)

Death from any cause or last follow-up, whichever occurs first.

Time frame
Up to 48 months after randomization
3

Operative Blood Loss

Intraoperative blood loss measured in milliliters and perioperative transfusion requirements.

Time frame
During surgery
4

Operative Time

Duration of surgical procedure measured in minutes from incision to skin closure.

Time frame
During surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: