Endoscopic Papillectomy Versus Surgery for Ampullary Tumors: A Prospective Multicenter Cohort Study

Patients undergoing EP with or without RFA.

Endoscopic papillectomy (EP); EP combined with intraductal RFA for lesions with intraductal tumor extension.

Patients undergoing surgical treatment.

TSA or PD

Recurrence confirmed by endoscopic biopsy after an interval ≥ 3 months from the end of treatment, assessed at the 12-month follow-up.

Proportion of patients with complete resection achieved at the first endoscopic or surgical intervention and confirmed by histology (negative margins).

Proportion of patients who experienced at least one adverse event attributable to the initial endoscopic or surgical procedure within 30 days after the procedure, irrespective of severity.

Recurrence confirmed by endoscopic biopsy after an interval ≥ 3 months from the end of treatment, assessed at the 6-month follow-up.

Presence of residual adenoma tissue at the next endoscopy after treatment.

Proportion of patients who achieved complete excision of the lesion (regardless of the number of procedures) with no histologically confirmed adenoma regrowth, no evidence of invasive cancer, and without the need for surgical resection, during follow-up up to 5 years after the initial treatment.

Inability to completely resect the lesion endoscopically (regardless of the number of procedures), histopathologically invasive malignancy, or recurrence no longer amenable to endoscopic treatment.

All readmissions due to disease-related symptoms (e.g., cholangitis, pancreatitis, obstructive jaundice) or treatment-related events (e.g., bleeding, perforation, anastomotic problems).

Proportion of patients in whom the planned procedure was completed as intended.

All direct medical costs from admission to 12 months after the initial treatment (including procedure, anesthesia, hospitalization, medication, examinations, and readmission costs).

Number of calendar days from the date of admission for the initial treatment to the date of discharge for the initial treatment,including the day of admission

Total number of calendar days spent in hospital within 12 months after the initial treatment, including the index hospitalization and all readmissions due to disease-related symptoms or treatment-related events.

Defined by two of three criteria: characteristic abdominal pain; amylase or lipase > 3× upper limit of normal; imaging features of pancreatitis; severity graded mild / moderate / severe per protocol.

Proportion of patients with clinically significant post-procedural bleeding within 30 days after the procedure, defined as any of the following after achieving primary haemostasis: overt bleeding symptoms (hematemesis, melena, hematochezia, or blood aspirated via nasogastric tube); haemodynamic instability attributable to bleeding; a decrease in haemoglobin greater than 2 g/dL; or direct endoscopic evidence of bleeding from the papillectomy site.

Direct visualization of a transmural defect during endoscopy, or radiographic evidence of extraluminal free air on abdominal CT or plain radiograph.

New onset temperature >38 °C for more than 24 hours combined with cholestasis. Severity will be graded separately according to the TG18 severity classification (Grade I / II / III) and reported descriptively.

Cumulative recurrence during annual follow-up up to 5 years