Intraoperative Endoscopic Ultrasound for Pancreatic Cancer

NCT04899739 | Completed

• 1 other identifier: 18-007
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Nowadays pancreatic cancer is one of the deadliest oncological pathologies. The only effective curative tool is the surgery. Before the intervention, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. In this study, the echoendoscopie will be extended to lymph node staging away from the surgical field in order to implement a simple classification of lymph nodes, based on non-invasive ultrasound criteria. This would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.

Conditions

Pancreatic Cancer

Keywords

EUS; Endoscopic Ultrasound; Biopsy; Pancreatic surgery; Pancreatic Cancer; Artificial intelligence

Outcome Measures

Primary Outcomes (2)

• Rate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity)

  Number of lymph nodes correctly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).

  1 month

• Rate of lymph nodes wrongly categorised by ultrasound endoscopy. (Specificity)

  Number of lymph nodes wrongly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).

  1 month

Secondary Outcomes (11)

• Rate of metastases actually diagnosed

  1 month

• Location of hidden lymph node metastases

  1 day

• Number of distant nodes detected during the endoscopic ultrasound

  1 day

• Number of distant malignant lymph nodes

  1 month

• Rate of patients for whom contraindications for surgery has been detected during the endoscopic ultrasound

  1 day

Study Arms (1)

Peripancreatic and distant lymph node assessment

EXPERIMENTAL

All patients programmed for an endoscopic ultrasound in the context of a pancreatic cancer

Diagnostic Test: Echoendoscopy

Interventions

Echoendoscopy DIAGNOSTIC_TEST

Peripancreatic lymph nodes and at a distance from the pancreas assessment by endoscopic ultrasound, elastography an doppler to record their anatomical location and characteristics. All lymph nodes suspected of metastatic disease will be marked with sterile black ink.

Peripancreatic and distant lymph node assessment

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years old
• Patient with a solid or degenerated cystic tumor of the pancreas requiring curative surgery
• Patient with a complete clinical examination performed
• Patient with no contraindication to anesthesia, upper digestive endoscopy and pancreatic surgery
• Patient able to receive and understand information relating to the study and give informed written consent
• Patient affiliated to the French social security system

You may not qualify if:

• Patient presenting with bleeding disease with disorder hemostasis and coagulation (PT \<60%, TCA\> 40 s and platelets \<60,000 / mm3)
• Patient on anticoagulant or antiaggregant treatment that cannot be temporarily interrupted
• Patient carrying a right-left shunt, a severe pulmonary arterial hypertension (high blood pressure pulmonary\> 90 mm Hg), uncontrolled systemic hypertension or suffering from respiratory distress syndrome.
• Pregnant or breastfeeding patient
• Patient under legal protection
• Patient under guardianship or trusteeship

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne

Strasbourg, 67000, France

Location

Related Publications (10)

• Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.

  PMID: 23335087 BACKGROUND

• Kleeff J, Reiser C, Hinz U, Bachmann J, Debus J, Jaeger D, Friess H, Buchler MW. Surgery for recurrent pancreatic ductal adenocarcinoma. Ann Surg. 2007 Apr;245(4):566-72. doi: 10.1097/01.sla.0000245845.06772.7d.

  PMID: 17414605 BACKGROUND

• Poruk KE, Firpo MA, Adler DG, Mulvihill SJ. Screening for pancreatic cancer: why, how, and who? Ann Surg. 2013 Jan;257(1):17-26. doi: 10.1097/SLA.0b013e31825ffbfb.

  PMID: 22895395 BACKGROUND

• Butturini G, Stocken DD, Wente MN, Jeekel H, Klinkenbijl JH, Bakkevold KE, Takada T, Amano H, Dervenis C, Bassi C, Buchler MW, Neoptolemos JP; Pancreatic Cancer Meta-Analysis Group. Influence of resection margins and treatment on survival in patients with pancreatic cancer: meta-analysis of randomized controlled trials. Arch Surg. 2008 Jan;143(1):75-83; discussion 83. doi: 10.1001/archsurg.2007.17.

  PMID: 18209156 BACKGROUND

• Galasso D, Carnuccio A, Larghi A. Pancreatic cancer: diagnosis and endoscopic staging. Eur Rev Med Pharmacol Sci. 2010 Apr;14(4):375-85.

  PMID: 20496552 BACKGROUND

• Al-Haddad M, Wallace MB, Woodward TA, Gross SA, Hodgens CM, Toton RD, Raimondo M. The safety of fine-needle aspiration guided by endoscopic ultrasound: a prospective study. Endoscopy. 2008 Mar;40(3):204-8. doi: 10.1055/s-2007-995336. Epub 2007 Dec 4.

  PMID: 18058615 BACKGROUND

• Bhutani MS, Hawes RH, Hoffman BJ. A comparison of the accuracy of echo features during endoscopic ultrasound (EUS) and EUS-guided fine-needle aspiration for diagnosis of malignant lymph node invasion. Gastrointest Endosc. 1997 Jun;45(6):474-9. doi: 10.1016/s0016-5107(97)70176-7.

  PMID: 9199903 BACKGROUND

• Kanamori A, Hirooka Y, Itoh A, Hashimoto S, Kawashima H, Hara K, Uchida H, Goto J, Ohmiya N, Niwa Y, Goto H. Usefulness of contrast-enhanced endoscopic ultrasonography in the differentiation between malignant and benign lymphadenopathy. Am J Gastroenterol. 2006 Jan;101(1):45-51. doi: 10.1111/j.1572-0241.2006.00394.x.

  PMID: 16405532 BACKGROUND

• Giovannini M, Thomas B, Erwan B, Christian P, Fabrice C, Benjamin E, Genevieve M, Paolo A, Pierre D, Robert Y, Walter S, Hanz S, Carl S, Christoph D, Pierre E, Jean-Luc VL, Jacques D, Peter V, Andrian S. Endoscopic ultrasound elastography for evaluation of lymph nodes and pancreatic masses: a multicenter study. World J Gastroenterol. 2009 Apr 7;15(13):1587-93. doi: 10.3748/wjg.15.1587.

  PMID: 19340900 BACKGROUND

• Nawaz H, Fan CY, Kloke J, Khalid A, McGrath K, Landsittel D, Papachristou GI. Performance characteristics of endoscopic ultrasound in the staging of pancreatic cancer: a meta-analysis. JOP. 2013 Sep 10;14(5):484-97. doi: 10.6092/1590-8577/1512.

  PMID: 24018593 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Patrick Pessaux, MD

  Unité de Chirurgie Hépato-biliaire et Pancréatique, NHC Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 24, 2021
• Study Start: December 5, 2021
• Primary Completion: June 4, 2025
• Study Completion: November 12, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)