Study Protocol of the ESAP Study: Endoscopic Papillectomy vs. Surgical Ampullectomy vs. Pancreaticoduodenectomy for Ampullary Neoplasm—A Pancreas2000/EPC Study
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 (T1 and
T2), 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 T2. 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,
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