Superior Mesenteric Artery First Versus Standard Approach in Pancreaticoduodenectomy

NCT07547033 | Not Yet Recruiting DMC

• 2 other identifiers: APHP2209202024-A02711-46
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 23

Brief 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. 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."

Conditions

Pancreatic Adenocarcinoma; Pancreatic Head Cancer

Keywords

surgical oncology

Outcome Measures

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.

  day of surgery

Secondary Outcomes (7)

• Disease-free survival (DFS)

  Up to 48 months after randomization

• Overall survival (OS)

  Up to 48 months after randomization

• Operative Blood Loss

  During surgery

• Operative Time

  During surgery

• Postoperative Complications

  Up to 3 months after surgery

Study Arms (2)

Standard arm (ST-PD)

ACTIVE COMPARATOR

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

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

Experimental arm (SMA-PD)

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: pancreaticoduodenectomy as standard of care

Standard arm (ST-PD)

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

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).

Also known as: SMA-PD

Experimental arm (SMA-PD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age 18 or over
• Grade 0 or 1 Performans Status (ECOG)
• Adequate contraception on fertile women
• Patient who provides a signed written informed consent form
• Patient having the rights to French social insurance

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (23)

CHU Amiens

Amiens, France

Location

CHU Angers

Angers, France

Location

CHU Besançon

Besançon, France

Location

Hôpital Haut Lévêque

Bordeaux, France

Location

Hôpital Estaing

Clermont-Ferrand, France

Location

Hôpital François Mitterrand

Dijon, France

Location

CHU Lille - Hôpital Claude Huriez

Lille, France

Location

Hôpital Claude Huriez

Lille, France

Location

CHU Dupuytren 1

Limoges, France

Location

Centre Léon Bérard

Lyon, France

Location

Hôpital de la Croix-Rousse

Lyon, France

Location

Hôpital Saint Eloi

Montpellier, France

Location

Hôpitaux de Brabois

Nancy, France

Location

Chu Nantes

Nantes, France

Location

Hôpital Ambroise Paré

Paris, France

Location

Hôpital Beaujon

Paris, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital de la Pitié Salpêtrière

Paris, France

Location

Hôpital Charles-Nicolle

Rouen, France

Location

CHU Strasbourg

Strasbourg, France

Location

Hôpital Rangueil

Toulouse, France

Location

Hôpital Paul Brousse

Villejuif, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Related Publications (25)

• 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.

  PMID: 15273542 BACKGROUND

• 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.

  PMID: 23728278 BACKGROUND

• 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.

  PMID: 33845462 BACKGROUND

• 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.

  PMID: 31751791 BACKGROUND

• 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.

  PMID: 32143434 BACKGROUND

• 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.

  PMID: 21369744 BACKGROUND

• 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.

  PMID: 25707813 BACKGROUND

• 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.

  PMID: 26293837 BACKGROUND

• 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.

  PMID: 25724606 BACKGROUND

• 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.

  PMID: 33630454 BACKGROUND

• 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.

  PMID: 25794484 BACKGROUND

• 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.

  PMID: 23464850 BACKGROUND

• 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.

  PMID: 31912902 BACKGROUND

• 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.

  PMID: 19723142 BACKGROUND

• 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.

  PMID: 18351300 BACKGROUND

• Verbeke CS, Leitch D, Menon KV, McMahon MJ, Guillou PJ, Anthoney A. Redefining the R1 resection in pancreatic cancer. Br J Surg. 2006 Oct;93(10):1232-7. doi: 10.1002/bjs.5397.

  PMID: 16804874 BACKGROUND

• Verbeke CS. Resection margins and R1 rates in pancreatic cancer--are we there yet? Histopathology. 2008 Jun;52(7):787-96. doi: 10.1111/j.1365-2559.2007.02935.x. Epub 2007 Dec 13.

  PMID: 18081813 BACKGROUND

• Hishinuma S, Ogata Y, Tomikawa M, Ozawa I, Hirabayashi K, Igarashi S. Patterns of recurrence after curative resection of pancreatic cancer, based on autopsy findings. J Gastrointest Surg. 2006 Apr;10(4):511-8. doi: 10.1016/j.gassur.2005.09.016.

  PMID: 16627216 BACKGROUND

• Pessaux P, Varma D, Arnaud JP. Pancreaticoduodenectomy: superior mesenteric artery first approach. J Gastrointest Surg. 2006 Apr;10(4):607-11. doi: 10.1016/j.gassur.2005.05.001. No abstract available.

  PMID: 16627229 BACKGROUND

• Whipple AO. Pancreaticoduodenectomy for Islet Carcinoma : A Five-Year Follow-Up. Ann Surg. 1945 Jun;121(6):847-52. doi: 10.1097/00000658-194506000-00008. No abstract available.

  PMID: 17858621 BACKGROUND

• Groot VP, Rezaee N, Wu W, Cameron JL, Fishman EK, Hruban RH, Weiss MJ, Zheng L, Wolfgang CL, He J. Patterns, Timing, and Predictors of Recurrence Following Pancreatectomy for Pancreatic Ductal Adenocarcinoma. Ann Surg. 2018 May;267(5):936-945. doi: 10.1097/SLA.0000000000002234.

  PMID: 28338509 BACKGROUND

• Neuzillet C, Tijeras-Raballand A, Bourget P, Cros J, Couvelard A, Sauvanet A, Vullierme MP, Tournigand C, Hammel P. State of the art and future directions of pancreatic ductal adenocarcinoma therapy. Pharmacol Ther. 2015 Nov;155:80-104. doi: 10.1016/j.pharmthera.2015.08.006. Epub 2015 Aug 20.

  PMID: 26299994 BACKGROUND

• Rahib L, Smith BD, Aizenberg R, Rosenzweig AB, Fleshman JM, Matrisian LM. Projecting cancer incidence and deaths to 2030: the unexpected burden of thyroid, liver, and pancreas cancers in the United States. Cancer Res. 2014 Jun 1;74(11):2913-21. doi: 10.1158/0008-5472.CAN-14-0155.

  PMID: 24840647 BACKGROUND

• Ferlay J, Partensky C, Bray F. More deaths from pancreatic cancer than breast cancer in the EU by 2017. Acta Oncol. 2016 Sep-Oct;55(9-10):1158-1160. doi: 10.1080/0284186X.2016.1197419. Epub 2016 Aug 23.

  PMID: 27551890 BACKGROUND

• Khorana AA, McKernin SE, Berlin J, Hong TS, Maitra A, Moravek C, Mumber M, Schulick R, Zeh HJ, Katz MHG. Potentially Curable Pancreatic Adenocarcinoma: ASCO Clinical Practice Guideline Update. J Clin Oncol. 2019 Aug 10;37(23):2082-2088. doi: 10.1200/JCO.19.00946. Epub 2019 Jun 10.

  PMID: 31180816 BACKGROUND

Related Links

• Protocol for the Examination of Specimens From Patients With Carcinoma of the Pancreas

MeSH Terms

Interventions

Pancreaticoduodenectomy; Standard of Care

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: April 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2031
• Last Updated: April 23, 2026

Record last verified: 2026-02

Locations

FR (23)