Pancreas Cancer, Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, PDAC
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Amsterdam UMC, location VUmc
Erasmus Medical Center
Catharina Ziekenhuis Eindhoven
Radboud University Medical Center
University Medical Center Groningen
Jeroen Bosch Ziekenhuis
Leiden University Medical Center
Maastricht University Medical Center
Maasstad Hospital
Amphia Hospital
Onze Lieve Vrouwe Gasthuis
Reinier de Graaf Groep
Isala
St. Antonius Hospital
UMC Utrecht
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | Within a follow-up period up to 5 years | Overall survival (from the time of resection), disease-free survival (from the time of resection), post-recurrence survival (from the time of recurrence diagnosis) |
| Incidence of PDAC recurrence | Within a follow-up period up to 5 years | 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. |
| Patterns of PDAC recurrence | Within a follow-up period up to 5 years | * 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 |
| Treatment of PDAC recurrence | Within a follow-up period up to 5 years | Either systemic and/or local treatment or best-supportive-care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of symptoms at time of (suspected) recurrence | Within a follow-up period up to 5 years | Which symptoms are associated with PDAC recurrence? |
| Performance score at time of recurrence detection | Within a follow-up period up to 5 years | What is the ECOG performance score of patients at time of recurrence diagnosis? |
| Use of imaging procedures during follow-up | Within a follow-up period up to 5 years | How much imaging procedures are performed during postoperative follow-up for the detection of PDAC recurrence? Are these procedures routinely performed? |
| Number of histologically confirmed recurrences | Within a follow-up period up to 5 years | How often is PDAC recurrence histologically confirmed? |
Countries
Netherlands
Contacts
Primary ContactIris van Goor, MD
Backup ContactLois Daamen, MD
Outcome results
None listed