Pancreatic Adenocarcinoma Clinical Trial
Official title:
Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors: A Multicenter Phase III Non-Inferiority Randomized Controlled Trial
This multicenter randomized trial aims to primarily assess and compare the functional recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and malignant lesions of the head of the pancreas.
The PORTAL trial is a Phase 3 multicenter non-inferiority randomized controlled trial that aims to address the question of feasibility and efficacy of the robotic minimally invasive approach in pancreaticoduodenectomy. In the past 10 years there has been an increasing number of retrospective series from major centers for pancreatic surgery worldwide, that demonstrate similar and occasionally improved postoperative outcomes in patients who undergo a robotic pancreaticoduodenectomy (Whipple). The benefits of this minimally invasive approach appear to be decreased intraoperative estimated blood loss, lower postoperative pain levels and smaller length of hospital stay, whereas postoperative complications rates are comparable with the standard open approach. This trial is conducted in multiple major centers for pancreatic surgery (open and robotic) in China and aims to address these questions in a prospective fashion. All eligible patients who present to these centers within the study period will be randomized in a 1:1 ratio to either of the two arms (open vs. robotic). Patients enrolled in the study will be blinded regarding the type of the procedure by application of identical wound dressings at the trocar sites and the open incision. Patients will be followed up closely and will be evaluated routinely for quality of life parameters for a period of at least 2 years postoperatively. Additionally, patients who undergo surgery in either arm for pancreatic adenocarcinoma will also be evaluated for time to adjuvant chemotherapy postoperatively, as well as recurrence and survival data. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05305001 -
Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
|
||
| Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
| Completed |
NCT01959672 -
Chemotherapy, Stereotactic Body Radiation Therapy & Nelfinavir Mesylate in Locally Advanced Pancreatic Cancer
|
Phase 2 | |
| Recruiting |
NCT03673423 -
Evaluation of the Interobserver Agreement on the Resectability Status of Patients With a Pancreatic Cancer
|
||
| Terminated |
NCT02495896 -
Recombinant EphB4-HSA Fusion Protein With Standard Chemotherapy Regimens in Treating Patients With Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
| Not yet recruiting |
NCT06026943 -
Alpha Radiation Emitters Device for the Treatment of Pancreatic Cancer Emitters for the Treatment of Locally Advanced Pancreatic Cancer
|
N/A | |
| Completed |
NCT03054987 -
Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction
|
N/A | |
| Terminated |
NCT02345460 -
Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study
|
Phase 2 | |
| Recruiting |
NCT02072616 -
Detection of Circulating Tumor Cells for the Diagnostic of Pancreatic Adenocarcinoma.
|
Phase 3 | |
| Completed |
NCT02174887 -
Biological Effect of Nab-paclitaxel Combined to Gemcitabine in Metastatic Pancreatic Cancer
|
Phase 1 | |
| Recruiting |
NCT03703063 -
Alternative Neoadjuvant Chemotherapy in Resectable and Borderline Resectable Pancreatic Cancer
|
Phase 1 | |
| Terminated |
NCT04077372 -
Assessment of a Serious Illness Conversation Guide (SICG) in Advanced Gastro-Intestinal Cancers
|
N/A | |
| Recruiting |
NCT03073785 -
Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer
|
Phase 2 | |
| Completed |
NCT03665441 -
Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC
|
Phase 3 | |
| Recruiting |
NCT04627246 -
Personalized Vaccine With SOC Chemo Followed by Nivo in Pancreatic Cancer
|
Phase 1 | |
| Not yet recruiting |
NCT06217666 -
Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)
|
Phase 1 | |
| Recruiting |
NCT05585320 -
A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT04119362 -
PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer
|
||
| Completed |
NCT03105921 -
Irreversible Electroporation (NanoKnife) for the Treatment of Pancreatic Adenocarcinoma
|
N/A |