Clinical trial · Interventional
Resection in Pancreatic Cancer With Minimal Metastatic Disease or Venous Infiltration Trial at Technische Universität München
Extended Versus Standard Resection in Two Cohorts of Patients With Adenocarcinoma of the Pancreas: Minimal Metastatic Disease or Venous Infiltration - a Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Protocol planned interim analysis after two years showed very low recruitment in cohort 1 and low recruitment in cohort 2.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Resection of infiltrated veins | Procedure | — | UNRESOLVED |
| Resection of metastases | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- 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
- interventionNames
- Procedure: Resection of metastases
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- 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
- interventionNames
- Procedure: Resection of infiltrated veins
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDArgentiero 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. PMID 33102398