Status:
COMPLETED
Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Intuitive Surgical
Conditions:
Pancreatic Adenocarcinoma
Pancreatic Cysts
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 t...
Detailed Description
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 pancre...
Eligibility Criteria
Inclusion
- Patients with an indication for elective pancreaticoduodenectomy for malignant, premalignant, and symptomatic benign disease in the pancreatic and periampullary region
- Performance status of 0/1 (assessed based on comorbidities using the Karnofsky score and Malnutrition Universal Screening Tool score among others, especially for patients with malignant disease)
- Imaging with computed tomography and/or MRI pancreas performed within 8 weeks for benign and 4 weeks for malignant disease; for the latter tumor staging with MRI liver, CT chest, and Cancer Antigen 19-9 is also mandatory.
Exclusion
- Body mass index \> 35 kg/m2
- Pregnancy
- Previous history of major abdominal surgery
- Requirement for multivisceral resection (additional surgical resection)
- Preoperative chemotherapy and/or radiotherapy (for patients with pancreatic adenocarcinoma)
- Involvement of major regional vessels by the tumor (portal and superior mesenteric vein, superior mesenteric artery, hepatic artery, celiac artery) as defined by the borderline resectable and locally advanced nomenclature
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT04400357
Start Date
September 28 2020
End Date
February 28 2025
Last Update
December 18 2025
Active Locations (1)
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1
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025