Clinical trial NCT06065891: Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer
Official title: Prevalence and Consequences of Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer: a Prospective Population Based Multicenter Study. The PALN Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreas Cancer
Pancreas Adenocarcinoma
Lymph Node Metastasis
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Prevalence of paraaortic lymph nodes in pancreatic cancer in patients submitted to a tentative curative resection
timeFrame: 5 years
Secondary outcomes:
measure: To determine prognosis of patients with PALN metastasis (lgll station 16) after a curative resection
timeFrame: 6 years
measure: To determine incidence of metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.
timeFrame: 5 years
measure: To determine prognosis of patients with metastasis in lgll station 8, 9 and 12 in patients submitted to a tentative curative resection.
timeFrame: 6 years
measure: To address the question of how to optimize the frozen section analyses (lgll station 16) as related to the final pathology report?
timeFrame: 5 years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
city: Göteborg
country: Sweden
facility: Sahlgrenska university hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Umeå
country: Sweden
facility: Norrland University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Britt-Marie Karlson
role: PRINCIPAL_INVESTIGATOR
References: