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Trial Title:
Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer
NCT ID:
NCT06065891
Condition:
Pancreas Cancer
Pancreas Adenocarcinoma
Lymph Node Metastasis
Conditions: Official terms:
Neoplasm Metastasis
Pancreatic Neoplasms
Lymphatic Metastasis
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
PALN resection
Description:
Resection of paraaortic lymph nodes in pancreatic cancer
Arm group label:
Resection of Paraartic lymph nodes
Summary:
Lymph node metastases are a strong prognostic predictor for pancreatic cancer.
Para-aortic lymph nodes (PALN) are the final nodes for periampullary cancers before the
cancer cells enter the systemic lymphatic circulation. Some consider these nodes to be
regional lymph nodes and dissect them as a part of a routine lymphadenectomy for
pancreatic cancer. Others argue that metastases to these nodes represent systemic disease
and recommend that radical surgery including extended lymphadenectomy should be
abandoned.
The aim of this study is to define the incidence and clinical consequences of PALN
metastasis in patients submitted to a tentative curative resection for carcinoma of the
head of the pancreas by systematically resecting paraaortic lymph nodes.
Primary outcome
1) To determine incidence of PALN metastasis in patients submitted to a tentative
curative resection
Secondary outcomes
1. To determine prognosis of patients with PALN metastasis after a curative resection
2. To determine incidence of metastasis in reginal lymph nodes in patients submitted to
a tentative curative resection.
3. To determine prognosis of patients with metastasis in regional lymph nodes in
patients submitted to a tentative curative resection.
4. To address the question of how to optimize the frozen section analyses of PALN as
related to the final pathology report.
300 patients are planned to be included in the trial.
Detailed description:
Lymph node metastases are a strong prognostic predictor for pancreatic cancer.
Para-aortic lymph nodes (PALN) (No. 16 nodes) are the final nodes for periampullary
cancers before the cancer cells enter the systemic lymphatic circulation. Some consider
these nodes to be regional lymph nodes and dissect them as a part of a routine
lymphadenectomy for pancreatic cancer. Others argue that metastases to these nodes
represent systemic disease and recommend that radical surgery including extended
lymphadenectomy should be abandoned. There is no consensus whether to abort the resection
if metastases in PALN are discovered pre- or perioperatively. Use of adjuvant and
neoadjuvant chemotherapy may further affect the impact of lymph node metastases,
including PALN.
The aim of this study is to define the incidence and clinical consequences of PALN
metastasis in patients submitted to a tentative curative resection for carcinoma of the
head of the pancreas by systematically resecting paraaortic lymph nodes.
Primary outcome
1) To determine incidence of PALN metastasis in patients submitted to a tentative
curative resection
Secondary outcomes
1. To determine prognosis of patients with PALN metastasis after a curative resection
2. To determine incidence of metastasis in reginal lymph nodes in patients submitted to
a tentative curative resection.
3. To determine prognosis of patients with metastasis in regional lymph nodes in
patients submitted to a tentative curative resection.
4. To address the question of how to optimize the frozen section analyses of PALN as
related to the final pathology report.
PALN are resected separately and analyzed both as cryo sections and by routine
histochemistry.
Prevalence of PALN differ markedly from 5% to 30%. Given the descriptive primary
endpoint, no rigorous power calculation can be made. Assuming a prevalence of 17% (as
reported in a recent series from Stockholm), a hazard ratio for survival ranging from
1,04 to 3,00 and and a drop out of 17%. Complete data is needed for 90 patients but the
trial aim to include 300.
Resection of PALN is becoming routine at most participating centers in the trial.
Therefore, the trial will not alter care for the participating patients in any major way.
Rather the trial aims to systematically asses how this altered practice affect patient
outcome.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Resectable suspected periampullary cancer (requiring duodenopancreatectomy) (NCCN
guidelines 2020)
Borderline resectable periampullary cancer (requiring duodenopancreatectomy) (NCCN
guidelines 2020)
Age >18 years
Written patient consent
Exclusion Criteria:
Contraindication for a radical resection procedure
Unresectable tumor (NCCN guidelines 2020) or metastatic disease (lgll station 16 not
included)
Mental or organic disorders which could interfere with giving informed consent or
receiving treatments
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Odense University Hospital
Address:
City:
Odense
Country:
Denmark
Status:
Not yet recruiting
Contact:
Last name:
Michael Bau Mortensen
Facility:
Name:
Sahlgrenska university hospital
Address:
City:
Göteborg
Country:
Sweden
Status:
Active, not recruiting
Facility:
Name:
Linköping University Hospital
Address:
City:
Linköping
Country:
Sweden
Status:
Active, not recruiting
Facility:
Name:
Skåne University Hospital
Address:
City:
Lund
Country:
Sweden
Status:
Active, not recruiting
Facility:
Name:
Norrland University Hospital
Address:
City:
Umeå
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Oskar Franklin
Facility:
Name:
Uppsala University Hospital
Address:
City:
Uppsala
Zip:
75653
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Jon Unosson
Phone:
0186110000
Email:
jon.unosson@uu.se
Start date:
September 5, 2023
Completion date:
September 5, 2028
Lead sponsor:
Agency:
Jon Unosson
Agency class:
Other
Source:
Uppsala University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06065891
