Pancreatic Cancer Recurrence in the Netherlands

Recruiting

• Conditions: Pancreas Cancer; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer; PDAC

• Registration Number: NCT04605237
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-24
• Study First Posted: 2020-10-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1750

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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)
Treatment of PDAC recurrence	Within a follow-up period up to 5 years	Either systemic and/or local treatment or best-supportive-care

Secondary Outcome Measures

Name	Time	Method
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?
Number of histologically confirmed recurrences	Within a follow-up period up to 5 years	How often is PDAC recurrence histologically confirmed?
Presence of symptoms at time of (suspected) recurrence	Within a follow-up period up to 5 years	Which symptoms are associated with PDAC recurrence?
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?

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands