The goal of this clinical trial is to learn if traditional pancreaticoduodenectomy (PD) combined with TRIANGLE (extended PD surgery) can increase disease-free survival (DFS) in patients with pancreatic head cancers compared to traditional minimally invasive PD. The main questions it aims to answer are:
* Does extended PD surgery increase disease-free survival (DFS)? * Does extended PD surgery could improve postoperative and long-term quality of life for patients? Researchers will compare extended PD surgery to traditional PD surgery to see if extended PD surgery could extend the survival time of patients.
Participants will:
* Accept traditional minimally invasive PD surgery or minimally invasive PD combined with TRIANGLE surgery. * Visit the clinic once every 3 months for checkups and tests. * Keep a diary of their symptoms.
Preoperative: a. Patients with suspected or histologically verified resectable, borderline or locally advanced pancreatic cancer of the pancreatic head (i.e. pancreatic ductal adenocarcinoma, intraductal papillary mucinous neoplasm (IPMN)-carcinoma or periampullary cancer of the pancreatobiliary-type) ; b. Patients scheduled for elective partial pancreatoduodenectomy (irrespective of neoadjuvant therapy); c. Assumed resectability in accordance with the surgical protocol for experimental and control intervention as judged by the treating surgeon; d. Ability of the subject to understand character and individual consequences of the clinical trial;e.Written informed consent; f. Age ≥ 18 years;
Intraoperative: a.No distant metastases; b.No paraaortic lymph node metastases; c.Intraoperative confirmation that the patient can be operated on according to both surgical methods.
Participation in another interventional trial with the interference of intervention and outcome of this trial;
American Society of Anesthesiologists (ASA) grade >3;
Distant metastatic disease .
Parallel
Expanded pancreaticoduodenectomy surgery
Procedure/SurgeryTraditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure
Pancreaticoduodenectomy
Procedure/SurgeryTraditional minimally invasive pancreaticoduodenectomy
Disease-free survival after resection
the primary outcome was DFS defined "as the time from randomisation until disease recurrence or death from any cause"
the rate of microscopically complete margin clearance
the rate of \>0.1 cm margin clearance, R0(CRM-)
the rate of microscopic margin clearance ≤ 0.1 cm
rate of R0(CRM+)
the rate of microscopic margin involvement (R1) resections
the rate of R1 resection, defined according to the 8th edition of the UICC TNM classification
the rate of postoperative pancreatic fistula
the POPF was defined by the International Study Group of Pancreatic Surgery (ISGPS)
Overall survival
Quality of Life questionnaire (QLQ-C30)
Defined according to the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire QLQ-C30
pancreatic cancer specific questionnaire (PAN26)
The European Organisation for Research and Treatment of Cancer (EORTC) pancreatic cancer specific questionnaire (QLQ-PAN26)
Local recurrence within the study period
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This trial is not recruiting at the moment. You can still explore other options:
