Tests removal of nodes behind the aorta during pancreatic cancer surgery
Studies how often pancreatic cancer spreads to lymph nodes behind the aorta.
Plain-language title generated from the registry record
Registry title: Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer
Key facts
- Where
- Odense, DenmarkSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need surgery to remove the head of the pancreas for a suspected cancer near the pancreas and bile duct. Lymph nodes beside the main blood vessel (aorta) are removed during the operation.
- Age
- Over 18 years
- Sex
- All sexes can join
- Disease stage
- Suspected cancer around the pancreas and bile duct that can be removed by surgery, or is borderline removable, and needs the operation called duodenopancreatectomy (NCCN guidelines 2020).
Main reasons for not taking part
- A health problem that rules out a radical (full-removal) operation
- A tumor that cannot be removed by surgery
- Cancer that has spread to other organs (lymph node station 16 is not counted)
- A mental or organ disorder that could get in the way of giving consent or receiving treatment
Read by machine on 9 November 2026.
Where in Denmark
- Odense University HospitalOdense, DenmarkNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jon Unosson
- Trial code
- NCT06065891
- Record updated
- 4 October 2023
- Original description
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.Read full original descriptionShow less
Prevalence and Consequences of Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer: a Prospective Population Based Multicenter Study. The PALN Study
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.
Inclusion: 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: Contraindication for a radical resection procedure; Mental or organic disorders which could interfere with giving informed consent or receiving treatments; Unresectable tumor (NCCN guidelines 2020) or metastatic disease (lgll station 16 not included).