AzTrials
AzTrials

Pancreatic AdenocarcinomaEQUINOXENCT07547033

Superior Mesenteric Artery First Versus Standard Approach in Pancreaticoduodenectomy

A study testing SMA-first pancreaticoduodenectomy using either right posterior or anterior approach. SMA identified and isolated with peri-adventitial dissection before any irreversible section. and Conventional pancreaticoduodenectomy without prior isolation of the SMA; antero-posterior approach of the uncinate process after pancreatic section. in people with Pancreatic Adenocarcinoma and Pancreatic Head Cancer, run by Assistance Publique - Hôpitaux de Paris at 23 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

"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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SMA-first pancreaticoduodenectomy using either right posterior or anterior approach. SMA identified and isolated with peri-adventitial dissection before any irreversible section. and Conventional pancreaticoduodenectomy without prior isolation of the SMA; antero-posterior approach of the uncinate process after pancreatic section.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
23 sitesFrance
Study dates
1 Sep 2026to 1 Sep 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • Pancreatic adenocarcinoma defined as "borderline" with arterial contact, locally advanced, non-resectable, or metastatic.
  • 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
  • Major non-controlled infection
  • Major comorbidity that may preclude the surgery
  • Severe liver failure
Show all 15Show fewer
  • 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
  • Pregnant or breastfeeding women and women of childbearing age not using effective means of contraception
  • Curatorship or guardianship or patient placed under judicial protection
  • Participation in other interventional research type 1, clinical investigation or clinical trial during the study
  • Secondary exclusion criterion (during surgery):
  • 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.
  • Anasthaesiologic complication (induction allergy or unprevisible heart disease at induction)
  • For fertile women: serological pregnancy test positive before surgery

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel Pietrasz, Medical Doctor contact

+33 45 49 66 92

daniel.pietrasz@aphp.fr

Antonhio Sa Cunha, MD PHD contact

+33 1 45 59 39 13

antonio.sacunha@aphp.fr

23 sites in 1 country

France23 sites

  • CHU Amiens

    Amiens

    Jean-Marc REGIMBEAU, MD PHD, regimbeau.jean-marc@chu-amiens.fr

  • CHU Angers

    Angers

    Emilie LERMITE, MD PHD, emlermite@chu-angers.fr

  • CHU Besançon

    Besançon

    Alexandre DOUSSOT, MD, adoussot@chu-besancon.fr

  • Hôpital Haut Lévêque

    Bordeaux

    Christophe LAURENT, MD PHD, christophe.laurent@chu-bordeaux.fr

  • Hôpital Estaing

    Clermont-Ferrand

    Emmanuel BUC, Professor, ebuc@chu-clermontferrand.fr

  • Hôpital François Mitterrand

    Dijon

    Jean-Baptiste Dr LEQUEU, Dr, jean-baptiste.lequeu@chu-dijon.fr

  • CHU Lille - Hôpital Claude Huriez

    Lille

    Stéphanie TRUANT, MD PHD, stephanie.truant@chu-lille.fr

  • Hôpital Claude Huriez

    Lille

    Julie VEZIANT, MD, Julie.veziant@chu-lille.fr

  • CHU Dupuytren 1

    Limoges

    Abdelkader TAIBI, Dr, abdelkader.taibi@chu-limoges.fr

  • Centre Léon Bérard

    Lyon

    Aurélien DUPRE, MD PHD, aurelien.dupre@lyon.unicancer.fr

  • Hôpital de la Croix-Rousse

    Lyon

    Jean-Yves MABRUT, MD PHD, jean-yves.mabrut@chu-lyon.fr

  • Hôpital Saint Eloi

    Montpellier

    François-Régis SOUCHE, Dr, Fr-souche@chu-montpellier.fr

  • Hôpitaux de Brabois

    Nancy

    Ahmet AYAV, MD PHD, a.ayav@chru-nancy.fr

  • Chu Nantes

    Nantes

    Nicolas REGENET, MD PHD, nicolas.regenet@chu-nantes.fr

  • Hôpital Ambroise Paré

    Paris

    Renato LUPINACI, MD PHD, renato.lupinacci@aphp.fr

  • Hôpital Beaujon

    Paris

    Alain SAUVANET, MD PHD, alain.sauvanet@aphp.fr

  • Hôpital Cochin

    Paris

    Ugo MARCHESE, MD, ugo.marchese@aphp.fr

  • Hôpital de la Pitié Salpêtrière

    Paris

    Gaujoux Sébastien, MD PHD, sebastien.gaujoux@aphp.fr

  • Hôpital Charles-Nicolle

    Rouen

    Lilian SCHWARZ, MD - PHD, lilian.schwarz@chu-rouen.fr

  • CHU Strasbourg

    Strasbourg

    Pietro ADDEO, MD PHD, pietrofrancesco.addeo@chru-strasbourg.fr

  • Hôpital Rangueil

    Toulouse

    Fabrice MUSCARI, MD PHD, muscari.f@chu-toulouse.fr

  • Hôpital Paul Brousse

    Villejuif

    Daniel Pietrasz, MD, +33 1 45 49 66 92, daniel.pietrasz@aphp.fr

  • Institut Gustave Roussy

    Villejuif

    Maximiliano GELLI, MD, maximiliano.gelli@gustaveroussy.fr

Other trials in France

About this study

"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.

Read more

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."

Read the detailed description

"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."

Being tested
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.
Keywords
surgical oncology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SMA-first pancreaticoduodenectomy using either right posterior or anterior approach. SMA identified and isolated with peri-adventitial dissection before any irreversible section.Procedure or surgery

    Also called SMA-PD

    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 or surgery

    Also called pancreaticoduodenectomy as standard of care

    Conventional pancreaticoduodenectomy without prior isolation of the SMA; antero-posterior approach of the uncinate process after pancreatic section.

Study groups in NCT07547033
Study groupRoleWhat they receive
Standard arm (ST-PD)Active comparatorConventional pancreaticoduodenectomy without prior isolation of the SMA; antero-posterior approach of the uncinate process after pancreatic section.
Receives: Procedure: Conventional pancreaticoduodenectomy without prior isolation of the SMA; antero-posterior approach of the uncinate process after pancreatic section.
Experimental arm (SMA-PD)ExperimentalSMA-first pancreaticoduodenectomy using either right posterior or anterior approach. SMA identified and isolated with peri-adventitial dissection before any irreversible section.
Receives: Procedure: SMA-first pancreaticoduodenectomy using either right posterior or anterior approach. SMA identified and isolated with peri-adventitial dissection before any irreversible section.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: day of surgery

Secondary outcomes (7)

  1. Disease-free survival (DFS)

    Disease-free survival will be evaluated using CT scans performed during follow-up

    Measured: Up to 48 months after randomization

  2. Overall survival (OS)

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

    Measured: Up to 48 months after randomization

  3. Operative Blood Loss

    Intraoperative blood loss measured in milliliters and perioperative transfusion requirements.

    Measured: During surgery

  4. Operative Time

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

    Measured: During surgery

  5. Postoperative Complications

    Postoperative complications assessed using Clavien-Dindo classification and Comprehensive Complication Index (CCI).

    Measured: Up to 3 months after surgery

  6. Postoperative Morbidity

    Morbidity will be assessed by comparing the percentage distribution of postoperative complications between the two groups

    Measured: Up to 3 months after surgery

  7. 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)

    Measured: At inclusion and 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2030 (estimated)
  4. Study completion1 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07547033
Sponsor's protocol ID
APHP220920
Other IDs
2024-A02711-46
Acronym
EQUINOXE
Status last verified
Feb 2026
First submitted
26 Feb 2026
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PubMed 15273542

  • Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013 Jul;258(1):1-7. doi: 10.1097/SLA.0b013e318296c732.

    PubMed 23728278

  • Tempero MA, Malafa MP, Al-Hawary M, Behrman SW, Benson AB, Cardin DB, Chiorean EG, Chung V, Czito B, Del Chiaro M, Dillhoff M, Donahue TR, Dotan E, Ferrone CR, Fountzilas C, Hardacre J, Hawkins WG, Klute K, Ko AH, Kunstman JW, LoConte N, Lowy AM, Moravek C, Nakakura EK, Narang AK, Obando J, Polanco PM, Reddy S, Reyngold M, Scaife C, Shen J, Vollmer C, Wolff RA, Wolpin BM, Lynn B, George GV. Pancreatic Adenocarcinoma, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021 Apr 1;19(4):439-457. doi: 10.6004/jnccn.2021.0017.

    PubMed 33845462

  • Jiang X, Yu Z, Ma Z, Deng H, Ren W, Shi W, Jiao Z. Superior mesenteric artery first approach can improve the clinical outcomes of pancreaticoduodenectomy: A meta-analysis. Int J Surg. 2020 Jan;73:14-24. doi: 10.1016/j.ijsu.2019.11.007. Epub 2019 Nov 18.

    PubMed 31751791

  • Kim SY, Choi M, Hwang HK, Rho SY, Lee WJ, Kang CM. Intraoperative Transfusion is Independently Associated with a Worse Prognosis in Resected Pancreatic Cancer-a Retrospective Cohort Analysis. J Clin Med. 2020 Mar 4;9(3):689. doi: 10.3390/jcm9030689.

    PubMed 32143434

  • Kneuertz PJ, Patel SH, Chu CK, Maithel SK, Sarmiento JM, Delman KA, Staley CA 3rd, Kooby DA. Effects of perioperative red blood cell transfusion on disease recurrence and survival after pancreaticoduodenectomy for ductal adenocarcinoma. Ann Surg Oncol. 2011 May;18(5):1327-34. doi: 10.1245/s10434-010-1476-3. Epub 2011 Jan 8.

    PubMed 21369744

  • Ejaz A, Spolverato G, Kim Y, Margonis GA, Gupta R, Amini N, Frank SM, Pawlik TM. Impact of blood transfusions and transfusion practices on long-term outcome following hepatopancreaticobiliary surgery. J Gastrointest Surg. 2015 May;19(5):887-96. doi: 10.1007/s11605-015-2776-5. Epub 2015 Feb 24.

    PubMed 25707813

  • Mavros MN, Xu L, Maqsood H, Gani F, Ejaz A, Spolverato G, Al-Refaie WB, Frank SM, Pawlik TM. Perioperative Blood Transfusion and the Prognosis of Pancreatic Cancer Surgery: Systematic Review and Meta-analysis. Ann Surg Oncol. 2015 Dec;22(13):4382-91. doi: 10.1245/s10434-015-4823-6. Epub 2015 Aug 21.

    PubMed 26293837

  • Cameron JL, He J. Two thousand consecutive pancreaticoduodenectomies. J Am Coll Surg. 2015 Apr;220(4):530-6. doi: 10.1016/j.jamcollsurg.2014.12.031. Epub 2015 Jan 6.

    PubMed 25724606

  • Bassi C, Marchegiani G, Giuliani T, Di Gioia A, Andrianello S, Zingaretti CC, Brentegani G, De Pastena M, Fontana M, Pea A, Paiella S, Malleo G, Tuveri M, Landoni L, Esposito A, Casetti L, Butturini G, Falconi M, Salvia R. Pancreatoduodenectomy at the Verona Pancreas Institute: the Evolution of Indications, Surgical Techniques, and Outcomes: A Retrospective Analysis of 3000 Consecutive Cases. Ann Surg. 2022 Dec 1;276(6):1029-1038. doi: 10.1097/SLA.0000000000004753. Epub 2021 Jan 15.

    PubMed 33630454

  • Amini N, Spolverato G, Kim Y, Pawlik TM. Trends in Hospital Volume and Failure to Rescue for Pancreatic Surgery. J Gastrointest Surg. 2015 Sep;19(9):1581-92. doi: 10.1007/s11605-015-2800-9. Epub 2015 Mar 21.

    PubMed 25794484

  • Delpero JR, Bachellier P, Regenet N, Le Treut YP, Paye F, Carrere N, Sauvanet A, Autret A, Turrini O, Monges-Ranchin G, Boher JM. Pancreaticoduodenectomy for pancreatic ductal adenocarcinoma: a French multicentre prospective evaluation of resection margins in 150 evaluable specimens. HPB (Oxford). 2014 Jan;16(1):20-33. doi: 10.1111/hpb.12061. Epub 2013 Mar 7.

    PubMed 23464850

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

    PubMed 31912902

  • Campbell F, Smith RA, Whelan P, Sutton R, Raraty M, Neoptolemos JP, Ghaneh P. Classification of R1 resections for pancreatic cancer: the prognostic relevance of tumour involvement within 1 mm of a resection margin. Histopathology. 2009 Sep;55(3):277-83. doi: 10.1111/j.1365-2559.2009.03376.x.

    PubMed 19723142

  • Esposito I, Kleeff J, Bergmann F, Reiser C, Herpel E, Friess H, Schirmacher P, Buchler MW. Most pancreatic cancer resections are R1 resections. Ann Surg Oncol. 2008 Jun;15(6):1651-60. doi: 10.1245/s10434-008-9839-8. Epub 2008 Mar 20.

    PubMed 18351300

Questions about this trial

What is this clinical trial studying?

A study testing SMA-first pancreaticoduodenectomy using either right posterior or anterior approach. SMA identified and isolated with peri-adventitial dissection before any irreversible section. and Conventional pancreaticoduodenectomy without prior isolation of the SMA; antero-posterior approach of the uncinate process after pancreatic section. in people with Pancreatic Adenocarcinoma and Pancreatic Head Cancer, run by Assistance Publique - Hôpitaux de Paris at 23 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel Pietrasz, Medical Doctor (+33 45 49 66 92, daniel.pietrasz@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 resection rate (clear margin > 1 mm) (time frame: day of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07547033, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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