Clinical trial NCT04899739: Intraoperative Endoscopic Ultrasound for Pancreatic Cancer
Official title: Prospective Study of Preoperative Diagnostic Endoscopy for the Diagnosis of Occult Metastatic Lesions of Operable Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Keywords: EUS
Endoscopic Ultrasound
Biopsy
Pancreatic surgery
Pancreatic Cancer
Artificial intelligence
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity)
timeFrame: 1 month
measure: Rate of lymph nodes wrongly categorised by ultrasound endoscopy. (Specificity)
timeFrame: 1 month
Secondary outcomes:
measure: Rate of metastases actually diagnosed
timeFrame: 1 month
measure: Location of hidden lymph node metastases
timeFrame: 1 day
measure: Number of distant nodes detected during the endoscopic ultrasound
timeFrame: 1 day
measure: Number of distant malignant lymph nodes
timeFrame: 1 month
measure: Rate of patients for whom contraindications for surgery has been detected during the endoscopic ultrasound
timeFrame: 1 day
measure: Rate of patients for whom elastography was required to identify lymph node metastases hidden away from the surgical site
timeFrame: 1 day
measure: Measurement of the operating time required to perform preoperative elastography
timeFrame: 1 day
measure: Measurement of the additional costs generated by materials required for preoperative elastography
timeFrame: 1 day
measure: Impact of sterile black ink marking of distant nodes during the preoperative EA
timeFrame: 1 day
measure: Development of an algorithm capable of detecting lymph nodes metastases by the mean of artificial intelligence
timeFrame: 1 day
measure: Development of an algorithm capable of characterizing lymph nodes metastases by the mean of artificial intelligence
timeFrame: 1 day
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne
Study officials:
affiliation: Unité de Chirurgie Hépato-biliaire et Pancréatique, NHC Strasbourg
name: Patrick Pessaux, MD
role: PRINCIPAL_INVESTIGATOR
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