Intraoperative Endoscopic Ultrasound for Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Prospective Study of Preoperative Diagnostic Endoscopy for the Diagnosis of Occult Metastatic Lesions of Operable Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Diagnostic Test: Echoendoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripancreatic and distant lymph node assessment<br>All patients programmed for an endoscopic ultrasound in the context of a pancreatic cancer | Diagnostic Test: Echoendoscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month | 
| Location of hidden lymph node metastases | Description of the location of hidden lymph node metastases identified by endoscopic ultrasound | 1 day | 
| Number of distant nodes detected during the endoscopic ultrasound | Number of distant nodes detected during the preoperative endoscopic ultrasound | 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 | 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. | 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 | 1 day | 
| Measurement of the operating time required to perform preoperative elastography | Measurement of the operating time (in minutes) required to perform preoperative elastography. | 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 | 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). | 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 | 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 | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS, Endoscopic Ultrasound, Biopsy, Pancreatic surgery, Pancreatic Cancer, Artificial intelligence