Detection, Treatment and Survival of Pancreatic Cancer Recurrence in the Netherlands
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- UMC Utrecht
- Enrollment
- 1,750
- Locations
- 1
- Primary Endpoint
- Incidence of PDAC recurrence
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Incidence of PDAC recurrence
Time Frame: 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
Time Frame: 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
Survival
Time Frame: 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)
Treatment of PDAC recurrence
Time Frame: Within a follow-up period up to 5 years
Either systemic and/or local treatment or best-supportive-care
Secondary Outcomes
- Number of histologically confirmed recurrences(Within a follow-up period up to 5 years)
- Performance score at time of recurrence detection(Within a follow-up period up to 5 years)
- Presence of symptoms at time of (suspected) recurrence(Within a follow-up period up to 5 years)
- Use of imaging procedures during follow-up(Within a follow-up period up to 5 years)
Investigators
Prof. dr. I.Q. Molenaar, MD, PhD
Prof. dr.
UMC Utrecht