No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Jon Unosson · Other
Who this trial is looking for
This trial is looking for patients with resectable or borderline resectable pancreatic cancer who might need surgery. Participants will have their para-aortic lymph nodes removed to understand how often cancer spreads to these nodes and what that means for their treatment outcomes.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with resectable or borderline resectable pancreatic cancer
I need a type of surgery called duodenopancreatectomy
I am over 18 years old
I can provide written consent to participate
You may not be able to join if
I cannot have a radical resection procedure
I have an unresectable tumor or metastatic disease
I have mental or organic disorders that affect my ability to give consent or receive treatment
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 re…
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.
Trial Locations
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City
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Status
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…
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
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