Trial Information

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

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.