Intraoperative Endoscopic Ultrasound for Pancreatic Cancer

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Diagnostic Test: Echoendoscopy

• Registration Number: NCT04899739
• Lead Sponsor: IHU Strasbourg

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).

Study Timeline

• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-24
• Study Start: 2021-12-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripancreatic and distant lymph node assessment	Echoendoscopy	All patients programmed for an endoscopic ultrasound in the context of a pancreatic cancer

Primary Outcome Measures

Name	Time	Method
Rate of lymph nodes correctly categorised by ultrasound endoscopy. (Sensitivity)	1 month	Number of lymph nodes correctly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).
Rate of lymph nodes wrongly categorised by ultrasound endoscopy. (Specificity)	1 month	Number of lymph nodes wrongly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).

Secondary Outcome Measures

Name	Time	Method
Location of hidden lymph node metastases	1 day	Description of the location of hidden lymph node metastases identified by endoscopic ultrasound
Number of distant nodes detected during the endoscopic ultrasound	1 day	Number of distant nodes detected during the preoperative endoscopic ultrasound
Rate of metastases actually diagnosed	1 month	Comparison between the number of suspected lymph nodes identified during preoperative endoscopic ultrasound and results of the histological analysis of these resected lymph nodes.
Measurement of the additional costs generated by materials required for preoperative elastography	1 day	Measurement of the additional costs (in euros) generated by materials required for preoperative elastography in resectable pancreas cancer patients
Rate of patients for whom contraindications for surgery has been detected during the endoscopic ultrasound	1 day	Number of patients for whom a contraindication to surgery has been detected during the endoscopic ultrasound, on the total number of patients included.
Number of distant malignant lymph nodes	1 month	Number of distant lymph nodes detected during the preoperative endoscopic ultrasound and whose malignancy has been confirmed by the gold standard
Rate of patients for whom elastography was required to identify lymph node metastases hidden away from the surgical site	1 day	Number of patients for whom elastography was required to identify distant hidden lymph node metastases
Measurement of the operating time required to perform preoperative elastography	1 day	Measurement of the operating time (in minutes) required to perform preoperative elastography.
Impact of sterile black ink marking of distant nodes during the preoperative EA	1 day	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).
Development of an algorithm capable of characterizing lymph nodes metastases by the mean of artificial intelligence	1 day	Deep learning-based analysis of video data from the ultrasound endoscopy
Development of an algorithm capable of detecting lymph nodes metastases by the mean of artificial intelligence	1 day	Deep learning-based analysis of video data from the ultrasound endoscopy

Trial Locations

Locations (1)

Service de Chirurgie Digestive et Endocrinienne; 🇫🇷 Strasbourg, France