Status:
TERMINATED
Preoperative/Neoadjuvant Therapy and Vascular Debranching Followed by Resection for Locally Advanced Pancreatic Cancer
Lead Sponsor:
Ulrich Ronellenfitsch, MD
Conditions:
Pancreas Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Pancreatic cancer continues to have a poor prognosis. Many patients are diagnosed with advanced disease. In a considerable proportion of these patients, the tumor has contact with or invades into arte...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Pancreatic cancer (pancreatic ductal adenocarcinoma, Intraductal papillary mucinous neoplasm (IPMN) - derived adenocarcinoma, adenosquamous carcinoma), diagnosed by preoperative biopsy or cytology or intraoperative biopsy during the visceral debranching procedure
- Evidence of locally advanced disease which is considered unresectable due to arterial invasion on CT or MRI according to National Comprehensive Cancer Network (NCCN) and International Study Group of Pancreatic Surgery (ISGPS) criteria:
- Tumor encasement (\>180°) of the superior mesenteric artery or celiac trunk
- Tumor encasement (\>180°) of a short segment of the hepatic artery
- OR
- Anatomic variation of the visceral arteries with vascularization of the liver or mesentery via collaterals which need to be ligated during tumor resection (e.g. gastroduodenal artery), as shown on CT or MRI
- OR
- High-grade stenosis or occlusion of either the celiac trunk or the superior mesenteric artery with vascularization of the liver or mesentery via collaterals which need to be ligated during tumor resection (e.g. gastroduodenal artery), as shown on CT or MRI, which is not amenable to endovascular revascularization
- Invasion of the portal or superior mesenteric vein may be present, but must be considered resectable (involvement with distortion or narrowing of the vein or occlusion of the vein with suitable vessel proximal and distal, allowing for safe resection and replacement) according to National Comprehensive Cancer Network (NCCN) and International Study Group of Pancreatic Surgery (ISGPS) criteria (11, 12)
- Provision of written informed consent prior to performance of study-specific procedures or assessments and willingness to comply with treatment and follow-up
- Exclusion Criteria
- Histologically proven peritoneal carcinomatosis (biopsies of macroscopically suspicious findings must be taken at the beginning of the operation and be analyzed immediately by fresh frozen section)
- Histologically proven distant metastatic disease
- Co-morbidities, organ function or physical status precluding visceral debranching or intensive neoadjuvant combination chemotherapy, as judged by the treating physicians
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with the patient's safety, provision of informed consent, or compliance with study procedures
Exclusion
Key Trial Info
Start Date :
February 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2024
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04136769
Start Date
February 7 2020
End Date
December 4 2024
Last Update
December 9 2024
Active Locations (3)
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1
University Hospital, Dpt. of Visceral, Vascular and Endocrine Surgery
Halle, Germany, 06120
2
University Hospital
Heidelberg, Germany, 69120
3
University Hospital
Ulm, Germany, 89081