European Appleby Registry for Pancreatic Cancer

Distal pancreatectomy with celiac axis resection (DP-CAR), also known as the modified Appleby procedure, is a complex pancreatic surgical procedure used in selected patients with locally advanced pancreatic ductal adenocarcinoma involving the pancreatic body and/or tail and the celiac axis. Although DP-CAR may offer a potentially curative treatment option, it is associated with substantial perioperative morbidity and specific risks of hepatic and gastric ischemia. The rarity of the procedure and its concentration in experienced hepato-pancreato-biliary (HPB) centers have limited the availability of high-quality prospective evidence.

The EURO-APPLEBY Registry pretends to be a prospective, multicenter, observational European registry established to systematically collect clinical data from consecutive eligible patients undergoing elective DP-CAR with curative intent for pancreatic ductal adenocarcinoma. The registry aims to describe contemporary European practice, evaluate perioperative safety and long-term oncological outcomes, identify prognostic factors, and assess differences in patient selection, surgical techniques, perioperative management, and outcomes across participating centers.

Eligible patients will be adults aged 18 years or older with pancreatic ductal adenocarcinoma of the pancreatic body and/or tail who undergo elective DP-CAR with curative intent and provide written informed consent when required by applicable regulations. Patients undergoing DP-CAR for other indications, emergency procedures, or additional arterial resections other than celiac axis resection will be excluded, as will patients previously enrolled for the same surgical episode.

The registry will collect data on patient demographics, comorbidities, functional status, nutritional status, tumor characteristics, clinical stage, neoadjuvant treatment, treatment response, preoperative imaging, vascular involvement, collateral circulation, and preoperative arterial embolization. Operative data will include surgical approach, operative time, blood loss, vascular management, intraoperative perfusion assessment, and associated procedures. Pathological data will include tumor stage, differentiation, lymph node involvement, treatment response, and resection margin status.

Postoperative outcomes will include overall complications, major morbidity, postoperative pancreatic fistula, postpancreatectomy hemorrhage, delayed gastric emptying, gastric and hepatic ischemia, reoperation, length of hospital stay, intensive care unit stay, readmission, and 90-day mortality. Long-term follow-up will capture adjuvant treatment, recurrence, disease-free survival, overall survival, and health-related quality of life where available.

The primary outcomes are postoperative morbidity, postoperative mortality, overall survival, and disease-free survival following DP-CAR. Secondary objectives include identifying predictors of gastric and hepatic ischemia, major postoperative complications, and long-term oncological outcomes; evaluating the effects of neoadjuvant therapy and surgical approach; assessing perioperative management and Enhanced Recovery After Surgery practices; and examining inter-center variability and surgeon procedural volume. The registry will also explore the potential role of standardized imaging, three-dimensional vascular reconstruction, and intraoperative perfusion assessment in surgical planning and risk prediction.

Approximately 100 patients are expected to be enrolled across participating European HPB centers during the planned 24-month recruitment period. This is a feasibility-based target, and no formal hypothesis-driven sample size calculation has been performed.

The study is observational and will not assign treatments or alter clinical decision-making. Diagnostic evaluation, neoadjuvant therapy, surgical strategy, perioperative care, and follow-up will be performed according to the standard practice of each participating institution. Data will be collected prospectively using a secure electronic case report form, with pseudonymization, standardized data definitions, data quality checks, and centralized monitoring.

Each participating center will obtain approval from its local ethics committee in accordance with applicable national regulations before enrolling patients. Written informed consent will be obtained when required by local regulations. The registry is intended to generate real-world evidence to support clinical benchmarking, improve the safety and effectiveness of DP-CAR, and inform future European recommendations for patient selection, operative technique, perioperative management, and outcome reporting.