Study Protocol of the ESAP Study: Endoscopic Papillectomy vs. Surgical Ampullectomy vs. Pancreaticoduodenectomy for Ampullary Neoplasm—A Pancreas2000/EPC Study

Abstract

Background: Lesions of the Ampulla of Vater are a rare condition and represent <10% of peri-ampullary neoplasms. Nevertheless, ampullary adenomas have the potential for malignant transformation to ampullary carcinomas by an adenoma-to-carcinoma sequence. Thus, adequate patient selection and complete resection (R0) of non-invasive ampullary lesions either by endoscopic papillectomy (EP), surgical ampullectomy (SA), or pancreaticoduodenectomy (PD) is essential. Although PD was traditionally performed, recent studies reported considerable efficacy and fewer complications following EP and SA. Since consistent comparative data are lacking, the Endoscopic Papillectomy vs. Surgical Ampullectomy vs. Pancreaticoduodectomy (ESAP) study will provide evidence for a therapeutic standard and post procedure morbidity in ampullary lesions. Methods: International multicenter retrospective study. Adult patients (>18 years of age) who underwent SA or PD for ampullary neoplasm between 2004 and 2018 or EP between 2007 and 2018 will be evaluated. Main inclusion criteria are ampullary lesions strictly located to the ampulla. This includes adenoma, adenocarcinoma (T 1 and T 2), neuroendocrine tumors, gastrointestinal stroma tumors and other rare conditions. Exclusion criteria are peri-ampullary lesions, e.g., from the duodenal wall or the head of the pancreas, and interventions for tumor stages higher than T 2. The main objective of this study is to analyze rates of complete resection (R0), recurrence and necessity for complementary interventions following EP, SA, and PD. Treatment-quality for each procedure will be defined by morbidity, mortality and complication rates and will be compared between EP, SA, and PD. Secondary objectives include outcome for patients with incomplete resection or initially understated tumors, lesions of the minor papilla, Hollenbach et al. ESAP hereditary syndromes, neuroendocrine tumors, mesenchymal lesions, and other rare conditions. Additionally, we will analyze therapy by argon plasma coagulation and radiofrequency ablation. Furthermore, outcome in curative and palliative interventions can be distinguished. Conclusion: The ESAP study will provide evidence for therapeutic algorithms and data for the implementation of guidelines in the treatment of different types of ampullary tumors, including recurrent, or incomplete resected lesions.

A nomogram diagnostic prediction model of pancreatic metastases of small cell lung carcinoma based on clinical characteristics, radiological features and biomarkers

“…Pancreatic metastasis of lung cancer is rare, accounting for less than 2% of all pancreatic malignancies ( 24 , 29 ), the majority being small-cell lung carcinoma (SCLC) ( 25 ). In previous studies on the differential diagnosis of PM from PDAC ( 18 , 26 ), in addition to small cell lung cancer, the primary tumors of these metastases also included non-small cell lung cancer, renal carcinoma, breast cancer, melanoma, gastrointestinal cancer, sarcoma ( 28 ).…”

“…The variables of CT imaging were as follows: tumor size (maximum diameter on axial images, the unit is mm), number (one, two, equal to or more than three lesions in the pancreas), location (head, neck, body or tail), tumor shape (round, lobulated or irregular), necrosis (presence or absence), margin (well-defined or ill-defined), parenchymal atrophy (presence or absence), retention cyst (presence or absence), peripancreatic fluid (presence or absence), vascular involvement [presence or absence), common bile duct dilatation (> 8 mm ( 25 )], pancreatic duct through (presence or absence), pancreatic duct dilatation (≥ 3 mm ( 26 )), pushed pancreatic duct (presence or absence), coeliac enlarged lymph nodes [short-axis diameter was larger than 10 mm or included necrosis of any size ( 27 , 28 )], peritumoral lymph nodes (none, 0<SD<8mm, SD≥8mm), relative density (low density, iso density, high density), blood supply (poor, rich), enhancement pattern (homogeneous, heterogeneous), enhancement degree (none, mild, moderate, strong), enhancement type (gradual, fast forward and backward, other), enhancement type1 (circular, overall, partial).…”

Duodenaladenome und -karzinome: chirurgische Therapiekonzepte

“…Bessere Daten hinsichtlich der tatsächlichen onkologischen Vergleichbarkeit könnte hierbei die aktuelle ESAP-Studie erbringen, welche die endoskopische Papillektomie mit der chirurgischen Ampullektomie bzw. der Pankreatikoduodenektomie bei ampullären Neoplasien untersucht 35 .…”

Surgical ampullectomy: A comprehensive review

“…Furthermore, the available evidence strongly suggests that randomization would be unethical. However, the ESAP study is a planned international multicentre retrospective cohort study which aims to compare EP, SA and PD for ampullary neoplasms[ 80 ]. Its methodology includes propensity score matching to account for differences in baseline characteristics of the cohorts.…”