Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Pancreatic duodenectomy is one of the treatments offered to patients with neoplastic disease of the pancreas. In France, in 2018, 14,000 duodeno-pancreatectomies were performed, including 140 at the Hautepierre hospital at the Strasbourg University Hospital. Pancreaticoduodenectomy is a major surgery, causing significant postoperative pain that should be minimized through multimodal analgesia involving in particular locoregional anesthesia. Since 2019, the recommendations of the ERAS company concerning ERAS (Improved Rehabilitation After Surgery) after pancreaticoduodenectomy recommend the establishment of thoracic epidural analgesia in order to limit postoperative pain. When there is a contraindication to the placement of a thoracic epidural, in particular due to arterial and/or venous vascular reconstructions requiring potential perioperative curative anticoagulation, the administration of local anesthetic by pericatricial catheter is recommended. recommended. The Transversus Abdominis Plane (TAP) block has proven analgesic efficacy, safety and harmlessness in colorectal surgery.

Efficacy of the Transversus Abdominis Plane Block on Analgesia After Cephalic Duodeno-pancreatectomy

Efficacy of the Transversus Abdominis Plane Block (TAP-Block) on Analgesia After Cephalic Duodeno-pancreatectomy

University Hospital, Strasbourg, France

Symptoms and General Pathology

Cysts

Precancerous Conditions

Pancreatic Cyst

Pathological Conditions, Anatomical

patients referred to Johns Hopkins Hospital for evaluation and or treatment for 1 or more pancreatic cysts

Anne Marie O'Broin-Lennon, MD

The aim is to propose and prospectively validate a diagnostic approach and model for prediction of mucinous versus non-mucinous, and malignant versus non-malignant pancreatic cysts using a combination of clinical, radiologic, and biomarker characteristics.

This combined cross-sectional and prospective single center clinical and translational study involves a collaborative multidisciplinary team composed of gastroenterologists, surgeons, radiologists, and basic scientists. Eligible patients with solitary or multiple pancreatic cysts referred for diagnostic evaluation and/or surgical treatment will undergo initial radiographic imaging with high-resolution CT, MRI/MRCP, and EUS/FNA as part of standard medical care at Johns Hopkins Hospital. This is a three-phase study.

In Phase I, eligible patients with pancreatic cysts will undergo initial radiographic imaging (high-resolution CT, MRI/MRCP, endoscopic ultrasonography (EUS) with fine needle aspiration (FNA)) as part of standard care at the Johns Hopkins Hospital. Patients will be categorized according to the presence of symptoms referable to the cyst or imaging features concerning for malignancy based on the initial radiographic assessment. Symptomatic patients, or those with concerning features, will be referred for surgical resection. The pathologic features and final diagnosis of resected pancreatic cysts will be compared with preoperative clinical, radiologic, and cyst fluid test results.

Asymptomatic patients with low-risk features at baseline radiographic and endoscopic imaging will enter Phase II. Patients will be followed on a prospective periodic surveillance schedule according the consensus clinical guidelines with either CT or MRI to monitor for new or metachronous cystic neoplasms. Those who develop symptoms or concerning features will have a repeat EUS/FNA as well as imaging with the opposite axial imaging modality, and will be referred for surgery if a suspicious lesion is detected.

Patients who have surgery either during Phase I or Phase II, will enter post-surgical surveillance (Phase III). Patients will be followed using a prospective periodic surveillance schedule according the consensus clinical guidelines with either CT or MRI to monitor for new or metachronous cystic neoplasms. Those who undergo surgery after surveillance in Phase II will continue with the imaging modality they were originally evaluated with prior to surgery.. Patients who develop symptoms or high-risk features on imaging will have a repeat EUS/FNA as well as imaging with the opposite axial imaging modality and will be referred for surgery if a suspicious lesion is detected. Samples will be collected prospectively for biomarker analysis. Cyst fluid, pancreatic juice and blood will be collected during EUS and blood will be collected yearly during the outpatient clinic visit. Patients will be followed for three years.

The Clinical,Radiologic,Pathologic and Molecular Marker Characteristics of Pancreatic Cysts Study

The Clinical,Radiologic, Pathologic and Molecular Marker Characteristics of Premalignant and Malignant Pancreatic Cysts Study

1)to determine the prevalence and incidence of malignancy in pancreatic cysts according to cyst size and concerning features

To collect tissue samples (cyst fluid and blood) for research on molecular markers in pancreatic cysts

To develop a panel of candidate biomarkers in pancreatic juice and serum as indicators of prevalent and incident malignancy in patients with surgically-proven neoplastic pancreatic cysts compared to non-neoplastic cysts (pseudocysts, lymphoepithelial cysts, congenital cysts)

to determine the sensitivity, specificity, and overall accuracy of pancreatic protocol CT, EUS, and/or MRCP in patients with pancreatic cysts, using surgical pathology as the reference standard

to calculate difference in diagnostic accuracy and clinical impact (change in preoperative diagnosis and treatment plan) of additional diagnostic tests (EUS and/or MRCP) over pancreatic protocol CT for the diagnosis of neoplastic/malignant pancreatic cysts.

to determine the factors associated with prevalent and incident malignancy in pancreatic cyst using a multivariate model including clinical, radiologic, and molecular markers

to determine the best model for prediction of malignancy in pancreatic cysts using multiple logistic regression and discriminant function analysis, including clinical, radiologic, and molecular markers

Study title	NCT ID	Conditions	Eligibility	Organization
Efficacy of the Transversus Abdominis Plane Block on Analgesia After Cephalic Duodeno-pancreatectomy	NCT05546970	Pancreatic Neop...	18 Years -	University Hospital, Strasbourg, France
The Clinical,Radiologic,Pathologic and Molecular Marker Characteristics of Pancreatic Cysts Study	NCT01202136	Pancreatic Cyst... Pancreatic Canc...	18 Years -	Johns Hopkins University
The Clinical,Radiologic,Pathologic and Molecular Marker Characteristics of Pancreatic Cysts Study	NCT01202136	Pancreatic Cyst... Pancreatic Canc...	18 Years -	Johns Hopkins University
Efficacy of the Transversus Abdominis Plane Block on Analgesia After Cephalic Duodeno-pancreatectomy	NCT05546970	Pancreatic Neop...	18 Years -	University Hospital, Strasbourg, France

Spots Global Cancer Trial Database for pancreatic neoplasia