Intraoperative Endoscopic Ultrasound for Pancreatic Cancer

NCT ID: NCT04899739

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-05
• Study Completion Date: 2025-12-31

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).

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Peripancreatic and distant lymph node assessment

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

Group Type: EXPERIMENTAL

Echoendoscopy

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Echoendoscopy

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IHU Strasbourg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Pessaux, MD

Role: PRINCIPAL_INVESTIGATOR

Unité de Chirurgie Hépato-biliaire et Pancréatique, NHC Strasbourg

Locations

Service de Chirurgie Digestive et Endocrinienne

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Armelle TAKEDA, PhD

Role: CONTACT

armelle.takeda@ihu-strasbourg.eu

0390413608

Facility Contacts

Patrick PESSAUX, MD

Role: primary

patrick.pessaux@chru-strasbourg.fr

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Other Identifiers

18-007

Identifier Type: -

Identifier Source: org_study_id