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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
45
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.
Service de Chirurgie Digestive et Endocrinienne
Strasbourg, France
RECRUITINGRate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity)
Number of lymph nodes correctly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).
Time frame: 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).
Time frame: 1 month
Rate of metastases actually diagnosed
Comparison between the number of suspected lymph nodes identified during preoperative endoscopic ultrasound and results of the histological analysis of these resected lymph nodes.
Time frame: 1 month
Location of hidden lymph node metastases
Description of the location of hidden lymph node metastases identified by endoscopic ultrasound
Time frame: 1 day
Number of distant nodes detected during the endoscopic ultrasound
Number of distant nodes detected during the preoperative endoscopic ultrasound
Time frame: 1 day
Number of distant malignant lymph nodes
Number of distant lymph nodes detected during the preoperative endoscopic ultrasound and whose malignancy has been confirmed by the gold standard
Time frame: 1 month
Rate of patients for whom contraindications for surgery has been detected during the endoscopic ultrasound
Number of patients for whom a contraindication to surgery has been detected during the endoscopic ultrasound, on the total number of patients included.
Time frame: 1 day
Rate of patients for whom elastography was required to identify lymph node metastases hidden away from the surgical site
Number of patients for whom elastography was required to identify distant hidden lymph node metastases
Time frame: 1 day
Measurement of the operating time required to perform preoperative elastography
Measurement of the operating time (in minutes) required to perform preoperative elastography.
Time frame: 1 day
Measurement of the additional costs generated by materials required for preoperative elastography
Measurement of the additional costs (in euros) generated by materials required for preoperative elastography in resectable pancreas cancer patients
Time frame: 1 day
Impact of sterile black ink marking of distant nodes during the preoperative EA
Analysis of the impact of sterile black ink marking of distant lymph nodes during preoperative ultrasound endoscopy on the surgical procedure by the mean of a questionnaire completed by the surgeon. This questionnaire will be assessed by a score of Likert varying between 1 (not satisfied) and 5 (very satisfied).
Time frame: 1 day
Development of an algorithm capable of detecting lymph nodes metastases by the mean of artificial intelligence
Deep learning-based analysis of video data from the ultrasound endoscopy
Time frame: 1 day
Development of an algorithm capable of characterizing lymph nodes metastases by the mean of artificial intelligence
Deep learning-based analysis of video data from the ultrasound endoscopy
Time frame: 1 day
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