Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06065891
Status:
RECRUITING
Last Update Posted:
2023-10-04
First Post:
2023-09-08
Brief Title:
Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer
Sponsor:
Jon Unosson
Organization:
Uppsala University Hospital
Study Overview
Official Title:
Prevalence and Consequences of Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer a Prospective Population Based Multicenter Study The PALN Study
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PALN
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
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 104 to 300 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
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 104 to 300 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None