Pancreatic Cancer Recurrence in the Netherlands

Study Overview
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Brief Summary
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The aim of this nationwide, observational cohort study is to evaluate current surveillance strategies after primary resection of pancreatic ductal adenocarcinoma (PDAC) in the Netherlands, with regard to the detection, treatment and survival of PDAC recurrence.

Official Title
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Detection, Treatment and Survival of Pancreatic Cancer Recurrence in the Netherlands

Conditions
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Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer, Pancreas Cancer, PDAC

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a pancreatic resection (PPPD, Whipple, distal pancreatectomy or total pancreatectomy) for histologically proven PDAC in one of the 16 Dutch centers for pancreatic surgery Exclusion Criteria: Patients with 30-day postoperative mortality
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PDAC recurrence | Incidence of PDAC recurrence within the Netherlands; PDAC recurrence is either pathologically proven, or suspected through cross-sectional imaging, preferably confirmed by consensus during a multidisciplinary meeting. | Within a follow-up period up to 5 years | 
| Patterns of PDAC recurrence | Asymptomatic vs. symptomatic: Symptomatic recurrence is defined as the presence of symptoms suggestive for PDAC recurrence at recurrence diagnosis. If PDAC recurrence is detected in absence of suspected symptoms, disease recurrence was defined as asymptomatic. First site of recurrence: isolated local recurrence, liver-only, lung-only, multiple-site, other isolated distant Early vs. late recurrence: disease-free survival ≥12 months vs. <12 months | Within a follow-up period up to 5 years | 
| Treatment of PDAC recurrence | Either systemic and/or local treatment or best-supportive-care | Within a follow-up period up to 5 years | 
| Survival | Overall survival (from the time of resection), disease-free survival (from the time of resection), post-recurrence survival (from the time of recurrence diagnosis) | Within a follow-up period up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of symptoms at time of (suspected) recurrence | Which symptoms are associated with PDAC recurrence? | Within a follow-up period up to 5 years | 
| Performance score at time of recurrence detection | What is the ECOG performance score of patients at time of recurrence diagnosis? | Within a follow-up period up to 5 years | 
| Use of imaging procedures during follow-up | How much imaging procedures are performed during postoperative follow-up for the detection of PDAC recurrence? Are these procedures routinely performed? | Within a follow-up period up to 5 years | 
| Number of histologically confirmed recurrences | How often is PDAC recurrence histologically confirmed? | Within a follow-up period up to 5 years |