Systematic Lymph Node Sampling and Analysis in Patients With Pancreatic Cancer

• Conditions: Pancreatic Cancer

• Registration Number: NCT02646462
• Lead Sponsor: Michael Bau Mortensen

Brief 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.

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

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-05
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-07
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ratio of malignant/total number of lymph nodes	12 months	Ratio between malignant and total number of lymph nodes in predefined lymph node stations

Secondary Outcome Measures

Name	Time	Method
Number of N1 patients	12 months	Number of patients with malignant lymph nodes in predefined lymph node stations

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense C, Denmark