Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Neuroendocrine Tumor

Pancreatic Neuroendocrine Tumor

Neuroepithelioma

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

PNETs ablation by radiofrequency treatment (1 to 3 sessions)

RFA is performed under general anaesthesia, under high endoscopic echo-endoscopy (EEH), in left lateral decubitus position, using the StarMed generator from Taewong®.

Radiofrequency ablation

Dominique GENRE, MD

GENRE Dominique, MD

GOUARNE Caroline, PhD

Fabrice CAILLOL, MD

Pancreatic radiofrequency ablation (RFA) could therefore be an alternative to the monitoring of pancreatic neuroendocrine tumors (PNETs) and more particularly nonfunctioning PNETs (NF-PNETs), which is costly and anxiety-inducing for patients. To date, only a few small studies have evaluated this treatment and the results are encouraging. It appears necessary to consider a large-scale study to ensure the efficacy and low morbidity of pancreatic RFA applied to PNETs.

The primary objective of the study is to evaluate the efficacy of radiofrequency treatment of grade 1 NF-PNETS with a size less than or equal to 2cm.

Patients meeting the selection criteria will be included in the study after signing the consent. They will benefit from a RFA treatment consisting of 1 to 3 sessions depending on their response to the treatment. Patients will then be followed for 5 years in order to evaluate their response to treatment, their clinical evolution, their quality of life and any complications.

Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors

Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size

Complete response rate to radiofrequency treatment defined by the absence of enhancement with the contrast agent and/or the disappearance of the lesion on imaging.

Institut Paoli-Calmettes

Gastrointestinal Agents

Pancrelipase

Pancreatin

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

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.

Echoendoscopy

Armelle TAKEDA, PhD

Patrick PESSAUX, MD

Patrick Pessaux, MD

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 "benign / malignant" of the nodes, established by the endoscopist using endoscopic ultrasound criteria's, compared to the gold standard (anatomopathology).

Intraoperative Endoscopic Ultrasound for Pancreatic Cancer

Prospective Study of Preoperative Diagnostic Endoscopy for the Diagnosis of Occult Metastatic Lesions of Operable Pancreatic Cancer

Number of lymph nodes correctly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).

Number of lymph nodes wrongly categorised by ultrasound endoscopy compared to the gold standard (anatomopathology).

Comparison between the number of suspected lymph nodes identified during preoperative endoscopic ultrasound and results of the histological analysis of these resected lymph nodes.

Description of the location of hidden lymph node metastases identified by endoscopic ultrasound

Number of distant nodes detected during the preoperative endoscopic ultrasound

Number of distant lymph nodes detected during the preoperative endoscopic ultrasound and whose malignancy has been confirmed by the gold standard

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 patients for whom elastography was required to identify distant hidden lymph node metastases

Measurement of the operating time (in minutes) required to perform preoperative elastography.

Measurement of the additional costs (in euros) generated by materials required for preoperative elastography in resectable pancreas cancer patients

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).

Deep learning-based analysis of video data from the ultrasound endoscopy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors	NCT04520932	Neuroendocrine ... Neuroendocrine ...	Radiofrequency ...	18 Years - 80 Years	Institut Paoli-Calmettes
Intraoperative Endoscopic Ultrasound for Pancreatic Cancer	NCT04899739	Pancreatic Canc...	Echoendoscopy	18 Years - 95 Years	IHU Strasbourg

Spots Global Cancer Trial Database for echoendoscopy