NCT07241676

Early Recurrence After Surgery for Pancreatic Cancer

Early Recurrence and Futility After Curative-intent Resection of Pancreatic Ductal Adenocarcinoma

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Azienda Ospedaliera di Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn about early recurrence after curative-intent surgery for pancreatic cancer. The main questions it aims to answer are: * How often does early recurrence (within 12 months after surgery) occur? * When does it happen, and at which anatomical sites (liver, lung, local, peritoneum)? * How is recurrence detected (imaging or tumor markers)? Adults with histologically confirmed pancreatic ductal adenocarcinoma who undergo curative-intent resection without distant metastases will be enrolled. Participants will be followed according to routine clinical care at each hospital, typically with imaging and CA19-9 blood tests. No study-specific interventions are required.

Detailed description

This international, prospective, multicenter observational study aims to characterize early recurrence (ER) after curative-intent resection of pancreatic ductal adenocarcinoma (PDAC). ER is defined as recurrence occurring within 12 months following surgery. The study will assess the incidence, timing, anatomical sites, and detection mode (radiologic vs. biochemical) of ER, as well as post-recurrence treatment patterns and short-term outcomes. Secondary aims include comparison between neoadjuvant and upfront surgery cohorts, evaluation of biochemical-only recurrence, and identification of clinical or pathological factors predictive of ER. Consecutive eligible patients will be enrolled from high-volume pancreatic surgery centers worldwide and followed according to institutional standards of care, typically involving routine imaging and CA19-9 surveillance. Standardized data will be prospectively collected to describe recurrence patterns and post-recurrence management. No study-specific interventions are required.

Conditions

• Pancreatic Ductal Adenocarcinoma (PDAC)
• Recurrent Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Curative-intent resection (R0, R1)	Standard-of-care surgical resection for pancreatic ductal adenocarcinoma, as determined by the multidisciplinary team. No study-specific interventions are mandated.

Timeline

• Start date: 2025-10-23
• Primary completion: 2026-09-30
• Completion: 2028-09-30
• First posted: 2025-11-21
• Last updated: 2025-11-21

Locations

1 site across 1 country: Italy