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2021-12-05
2025-06
2025-12
45
NCT04899739
IHU Strasbourg
IHU Strasbourg
INTERVENTIONAL
Intraoperative Endoscopic Ultrasound for Pancreatic Cancer
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 ⊾nign / malignant" of the nodes, established by the endoscopist using endoscopic ultrasound criteria's, compared to the gold standard (anatomopathology).
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-05-21 | N/A | 2025-04-29 |
2021-05-21 | N/A | 2025-05-01 |
2021-05-24 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Peripancreatic and distant lymph node assessment All patients programmed for an endoscopic ultrasound in the context of a pancreatic cancer | DIAGNOSTIC_TEST: Echoendoscopy
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Armelle TAKEDA, PhD Phone Number: 0390413608 Email: armelle.takeda@ihu-strasbourg.eu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
