Intraoperative Endoscopic Ultrasound for Pancreatic Cancer (EchoSurg)

  • STATUS
    Recruiting
  • End date
    Dec 20, 2024
  • participants needed
    45
  • sponsor
    IHU Strasbourg
Updated on 20 April 2022
endoscopic ultrasound
pancreatic neoplasm

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.

Description

Nowadays pancreatic cancer is one of the deadliest oncological pathologies today. Even after curative surgery, considered the only effective curative tool, 5-years survival does not exceed 5%. Before surgery, an endoscopic ultrasound is performed on the patient to carry out the biopsy of the main tumor. However, the evaluation being devoted to the pancreas, this study wishes to extend echoendoscopie to lymph node staging away from the surgical field. The proposed study is based on the hypothesis that the implementation of a simple classification of lymph nodes, based on non-invasive ultrasound criteria, would facilitate the location and qualification of peripancreatic lymph nodes and distant from the tumor, and therefore the staging of the tumor.

At the same time, the video data obtained will be collected in a computer database in order to create an artificial intelligence lesion detection and qualification tool.

This study plans to recruit 45 adult patients, male or female, with a solid or cystic pancreatic tumor and for whom a surgical resection (first line and after neoadjuvant treatment) is planned. The main objective is to estimate the sensitivity and specificity of a simple classification "benign / malignant" of the nodes, established by the endoscopist using endoscopic ultrasound criteria's, compared to the gold standard (anatomopathology).

Details
Condition Pancreatic Cancer
Treatment Echoendoscopy
Clinical Study IdentifierNCT04899739
SponsorIHU Strasbourg
Last Modified on20 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 in exclusion period (determined by a previous study or in progress)
Patient under legal protection
Patient under guardianship or trusteeship
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