NCT04400357Completed
Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors
Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors: A Multicenter Phase III Non-Inferiority Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 268 (actual)
- First submitted
- 10 May 2020
- Start date
- 28 Sept 2020
- Primary completion date
- 28 Nov 2024
- Lead sponsor
- Ruijin Hospital
- NCT number
- NCT04400357
What you commit to
- Study type: Interventional
- Participants enrolled: 268
- From 28 Sept 2020 to the primary completion date, 28 Nov 2024
- 1 site in 1 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.
Prior treatment
- Previous history of major abdominal surgery
- Requirement for multivisceral resection (additional surgical resection)
- Preoperative chemotherapy and/or radiotherapy (for patients with pancreatic adenocarcinoma)
Other
- Body mass index \> 35 kg/m2
- Pregnancy
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.