Resection In Pancreatic Cancer With Minimal Metastatic Disease Or Venous Infiltration Trial At Technische Universität München

Study Overview

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

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.

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.

Pancreatic Cancer

PROCEDURE: Resection of metastases
PROCEDURE: Resection of infiltrated veins

TUM-Chir-001/2009

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-03-03	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-09-05
First Submitted that Met QC Criteria 2009-03-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-09-06
First Posted (ESTIMATED) 2009-03-04	Results First Posted N/A	Last Verified 2009-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 1 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/choledochojejunosto	PROCEDURE: Resection of metastases resection of the primary tumor, followed by resection of the liver metastasis/metastases
ACTIVE_COMPARATOR: 2 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 porta	PROCEDURE: Resection of infiltrated veins resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 1

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/choledochojejunosto

PROCEDURE: Resection of metastases

resection of the primary tumor, followed by resection of the liver metastasis/metastases

ACTIVE_COMPARATOR: 2

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 porta

PROCEDURE: Resection of infiltrated veins

resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic

Primary Outcome Measures	Measure Description	Time Frame
Overall survival		3 years

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Argentiero A, Calabrese A, Sciacovelli AM, Delcuratolo S, Solimando AG, Brunetti O. Complete Response of Synchronous Liver Metastasis in a Pancreatic Ductal Adenocarcinoma, When Surgery Could Represent a Therapeutic Option. Can J Gastroenterol Hepatol. 2020 Oct 9;2020:8679751. doi: 10.1155/2020/8679751. eCollection 2020.

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Clinical Trial Record