Resection in Pancreatic Cancer With Minimal Metastatic Disease or Venous Infiltration Trial at Technische Universität München

Study Overview
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Brief Summary
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PaMeViTUM is a mono-centric prospective randomized controlled trial that compares different operating procedures in patients with pancreatic cancer and minimal metastatic disease or venous infiltration.

Detailed Description
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PaMeViTUM is a mono-centric prospective randomized controlled trial comparing different operating procedures in patients with pancreatic cancer and minimal metastatic disease or venous infiltration. Patients will be randomized intraoperatively after fulfilling all inclusion criteria (in particular: suspicion of cancer of the pancreas and an intraoperative histologically proven diagnosis of pancreatic adenocarcinoma; intraoperative assessment of tumor as potentially locally respectable). If no metastases and no infiltration of the portal vein are detected during the operation, the standard resection will be performed (for tumors of the pancreatic head: (pylorus-preserving) pancreaticoduodenectomy; for tumors of the pancreatic body/tail: distal (left) pancreatic resections; for tumors of the head and body/tail: total pancreatectomy). In the case of tumor infiltration of the pyloric region or the distal stomach, a classical pancreaticoduodenectomy will be performed. If the patient has pancreatic cancer with minimal metastatic disease (COHORT 1) and fulfills all inclusion criteria, she/he will be randomized into one of the following arms: Arm 1 (intervention): resection of the primary tumor, followed by resection of the liver metastasis/metastases Arm 2 (control): exploration and/or gastroenterostomy and/or hepaticojejunostomy/choledochojejunostomy If there are no liver metastases, following mobilization (and potentially also the dissection of the pancreas at the pancreatic head), the extension of the tumor towards the superior mesenteric/splenic/portal vein is examined. If there is venous infiltration (COHORT 2) and the patient fulfills the inclusion criteria, she/he will be randomized into one of the following arms: Arm 1 (intervention): resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic vein (SMV/SV) Arm 2 (control): resection of the primary tumor with dissection of the portal vein (and/or superior mesenteric vein/splenic vein (SMV/SV) plus tumor masses adjacent to these veins; no venous resection The aim of this study is to demonstrate that an extension of the resectability criteria in patients with pancreatic cancer and 1) minimal metastatic disease OR 2) venous infiltration improves overall survival. A secondary aim of the study is to prove that resection in these patient cohorts improves quality of life.

Official Title
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Extended Versus Standard Resection in Two Cohorts of Patients With Adenocarcinoma of the Pancreas: Minimal Metastatic Disease or Venous Infiltration - a Randomized Trial

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Procedure: Resection of metastases
* Procedure: Resection of infiltrated veins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suspicion of cancer of the pancreas and an intraoperative histologically proven diagnosis of pancreatic adenocarcinoma. intraoperative assessment of tumor as potentially locally resectable COHORT 1: Minimal metastatic disease COHORT 2: Venous infiltration ability to sign the informed consent. Karnofsky performance status > 70. Life-expectancy of more than 3 months. able to attend follow-up. no previous or concurrent malignancy diagnoses, except non-melanoma skin cancer and in situ carcinoma of the cervix. no serious medical, psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up. patients older than 18 years. no pregnant or lactating women. preoperative evaluation by thin-sliced CT scans with: No evidence of substantial extra-pancreatic disease, i.e. no evidence of malignant ascites, extended liver metastasis (>5 metastatic lesions), spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs. No evidence of extension of the tumor into the celiac axis or superior mesenteric artery (T4 disease). intraoperative findings with: tumor assessed as potentially locally resectable. no signs of peritoneal metastasis or tumor manifestations outside of the pancreas and the liver. frozen section: adenocarcinoma Exclusion Criteria: extrapancreatic disease (except minimal metastatic disease of the liver, see above) concomitant venous infiltration and minimal metastatic disease extension of the tumor into the celiac axis or superior mesenteric artery life expectancy of less than 3 months previous or concurrent malignancy diagnosis, except non-melanoma skin cancer and in situ carcinoma of the cervix conditions potentially hampering compliance (also inclusion criteria)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>COHORT 1 (minimal metastatic disease): Arm 1 (intervention): resection of the primary tumor, followed by resection of the liver metastasis/metastases Arm 2 (control): exploration and/or gastroenterostomy and/or hepaticojejunostomy/choledochojejunostomy | Procedure: Resection of metastases<br>* resection of the primary tumor, followed by resection of the liver metastasis/metastases<br>|
| Active Comparator: 2<br>COHORT 2 (venous infiltration): Arm 1 (intervention): resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic vein (SMV/SV) Arm 2 (control): resection of the primary tumor with dissection of the portal vein (and/or superior mesenteric vein/splenic vein (SMV/SV) plus tumor masses adjacent to these veins; no venous resection | Procedure: Resection of infiltrated veins<br>* resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life Perioperative morbidity and mortality 1-year survival and 2-year survival |  | Additional 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, metastasis, venous infiltration, Pancreatic cancer with minimal metastatic disease or venous infiltration