Intraoperative Endoscopic Ultrasound for Pancreatic Cancer (EchoSurg)

IHU Strasbourg

Status: Enrolling

Conditions: Pancreatic Cancer

Treatments: Diagnostic Test: Echoendoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04899739

18-007

Details and patient eligibility

About

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.

Full 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).

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Peripancreatic and distant lymph node assessment

Experimental group

Description:

All patients programmed for an endoscopic ultrasound in the context of a pancreatic cancer

Treatment:

Diagnostic Test: Echoendoscopy