Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers – the randomized controlled TRIANGLE trial
- Conditions
- Head of pancreasC25.0
- Registration Number
- DRKS00030576
- Lead Sponsor
- Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 270
Preoperative inclusion criteria:
- Patients with suspected or histologically verified resectable, borderline or locally advanced pancreatic cancer of the pancreatic head (i.e. pancreatic ductal adenocarcinoma, IPMN (Intraductal Papillary Mucinous Neoplasms) carcinoma or periampullary cancer of the pancreatobiliary-type)
- Patients scheduled for elective partial pancreatoduodenectomy (irrespective of neoadjuvant therapy)
- Assumed resectability in accordance with the surgical protocol for experimental and control intervention as judged by the treating surgeon
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent
- Age =18 years
Intraoperative inclusion criteria (prior to randomisation):
- No distant metastases
- No paraaortic lymph node metastases
- Intraoperative confirmation that the patient can be operated according to both surgical methods (experimental or control group)
- Participation in another interventional trial with interference of intervention and outcome of this trial
- American Society of Anesthesiologists (ASA) grade > 3
- Distant metastatic disease
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival (DFS) after index operation, defined as the time from randomisation until disease recurrence (local recurrence or metastases) or death from any cause
- Secondary Outcome Measures
Name Time Method