Clinical trial · Interventional
Intraoperative Endoscopic Ultrasound for Pancreatic Cancer
Prospective Study of Preoperative Diagnostic Endoscopy for the Diagnosis of Occult Metastatic Lesions of Operable Pancreatic Cancer
NCT04899739CI-TRIAL-00108691EchoSurgcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Echoendoscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Peripancreatic and distant lymph node assessment
- description
- All patients programmed for an endoscopic ultrasound in the context of a pancreatic cancer
- interventionNames
- Diagnostic Test: Echoendoscopy
Primary outcomes (2)
- measure
- Rate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity)
- timeFrame
- 1 month
- description
- Number of lymph nodes correctly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).
- measure
- Rate of lymph nodes wrongly categorised by ultrasound endoscopy. (Specificity)
- timeFrame
- 1 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient over 18 years old 2. Patient with a solid or degenerated cystic tumor of the pancreas requiring curative surgery 3. Patient with a complete clinical examination performed 4. Patient with no contraindication to anesthesia, upper digestive endoscopy and pancreatic surgery 5. Patient able to receive and understand information relating to the study and give informed written consent 6. Patient affiliated to the French social security system Exclusion Criteria: 1. Patient presenting with bleeding disease with disorder hemostasis and coagulation (PT \<60%, TCA\> 40 s and platelets \<60,000 / mm3) 2. Patient on anticoagulant or antiaggregant treatment that cannot be temporarily interrupted 3. 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. 4. Pregnant or breastfeeding patient 5. Patient in exclusion period (determined by a previous study or in progress) 6. Patient under legal protection 7. Patient under guardianship or trusteeship
References
Publications (10)
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- BACKGROUNDKleeff 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
- BACKGROUNDPoruk 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
- BACKGROUNDButturini 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
- BACKGROUNDGalasso D, Carnuccio A, Larghi A. Pancreatic cancer: diagnosis and endoscopic staging. Eur Rev Med Pharmacol Sci. 2010 Apr;14(4):375-85. PMID 20496552
- BACKGROUNDAl-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
- BACKGROUNDBhutani 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.