NCT06703905Not yet recruiting
Conventional Partial Pancreatoduodenectomy Versus an Extended Pancreatoduodenectomy for Pancreatic Head Cancers
Short and Long-term Outcomes of Minimally Invasive Pancreatoduodenectomy Combined with Triangle Operation for Resectable Pancreatic Cancer: an International Multicenter Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 25 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- First submitted
- 18 Nov 2024
- Start date
- Dec 2024
- Primary completion date
- Dec 2028
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Diseases
- Pancreatic cancer
- NCT number
- NCT06703905
What you commit to
- Study type: Interventional
- Planned participants: 270
- From Dec 2024 to the primary completion date, Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Distant metastatic disease .
Other
- Participation in another interventional trial with the interference of intervention and outcome of this trial;
- American Society of Anesthesiologists (ASA) grade \>3;
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.