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Status unknownNCT02646462Updated Jan 7, 2016

Systematic Lymph Node Sampling and Analysis in Patients With Pancreatic Cancer

An observational study in Pancreatic Cancer, sponsored by Michael Bau Mortensen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-01-07.

Sponsored by Michael Bau Mortensen · Observational

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Prospective investigation of the ratio between malignant and total number of lymph nodes in predefined lymph node stations in patients resected for pancreatic adenocarcinoma. A national Danish project.

Read the detailed description

Lymph nodes will be sampled from the following stations in patients with adenocarcinomas of the pancreas Group 6: Infrapyloric lymph nodes (IP) Group 8: Lymph nodes around the common hepatic artery (CHA) Group 12: Lymph nodes of the hepatoduodenal ligament (HDL) Group 13: Posterior pancreaticoduodenal lymph nodes Group 14: Lymph nodes around the superior mesenteric artery (SMA) Group 17: Anterior pancreaticoduodenal lymph nodes

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • pancreas adenocarcinoma, lymph node metastases
03

In context

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Michael Bau Mortensen is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Bioptic verified pancreatic adenocarcinoma or periampullary adenocarcinoma (within 20mm of the papilla) referred for pancreas resection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Bioptic verified pancreatic adenocarcinoma or periampullary adenocarcinoma (within 20mm of the papilla)

Exclusion criteria

Exclusion Criteria:

Patients with non-adenocarcinoma tumors of the pancreas or periampullary region

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Ratio of malignant/total number of lymph nodes

    Ratio between malignant and total number of lymph nodes in predefined lymph node stations

    Time frame: 12 months

Secondary outcomes

  1. Number of N1 patients

    Number of patients with malignant lymph nodes in predefined lymph node stations

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Odense University Hospital
    Odense C, 5000, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of Jun 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2015
First posted
Jan 5, 2016
Start
Jun 2015
Primary completionEst.
Jun 2016
CompletionEst.
Dec 2016
Last update
Jan 7, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02646462
Lead sponsor
Michael Bau Mortensen
Responsible party
Michael Bau Mortensen (professor, MD, PhD, DMSci, Odense University Hospital) — Sponsor-investigator
First posted
Jan 5, 2016
Start date
Jun 2015
Primary completion
Jun 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jan 7, 2016

Study contacts

Michael B Mortensen, MD, PhD,
Contact
michael.bau.mortensen@rsyd.dk
45 6541 1857

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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