Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 Resectable | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Expanded pancreaticoduodenectomy surgery | Procedure | — | UNRESOLVED |
| Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PD group
- description
- Traditional minimally invasive pancreaticoduodenectomy
- interventionNames
- Procedure: Pancreaticoduodenectomy
- type
- EXPERIMENTAL
- label
- expanded PD group
- description
- Traditional minimally invasive pancreaticoduodenectomy combined with the TRIANGLE procedure
- interventionNames
- Procedure: Expanded pancreaticoduodenectomy surgery
Primary outcomes (1)
- measure
- Disease-free survival after resection
- timeFrame
- 3, 6, 12, 18, 24, 30, 36 months after surgery (or early termination of the trial)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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; 2. 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. Exclusion Criteria: 1. Participation in another interventional trial with the interference of intervention and outcome of this trial; 2. American Society of Anesthesiologists (ASA) grade \>3; 3. Distant metastatic disease .
References
Publications (0)
Data not yet available