Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors (NCT04400357) | Clinical Trial Compass
CompletedNot Applicable
Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors
China268 participantsStarted 2020-09-28
Plain-language 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 the head of the pancreas.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial directly compared robotic versus open pancreaticoduodenectomy and has already completed, has my doctor seen the results, and do those results suggest one approach leads to faster functional recovery for someone with my specific diagnosis?
2Given that my condition — whether it's pancreatic adenocarcinoma, an ampullary tumor, or something else on this list — might behave differently after surgery, does the type of tumor I have affect which surgical approach my doctor would recommend based on what this trial found?
3This trial measured 'time to functional recovery' as its main outcome — can my doctor explain what that actually means in practical terms, like how soon I might be able to eat, walk, or leave the hospital, and how the robotic approach compared to open surgery on that measure?
4Since this trial is now completed and no longer enrolling, does my doctor have access to its findings, and how are those findings shaping the way they currently perform pancreaticoduodenectomy at this facility?
5Robotic surgery requires specialized equipment and training — can my doctor tell me whether their surgical team has significant experience with robotic pancreaticoduodenectomy, and whether that experience level is comparable to what was used in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to functional recovery postoperatively
Timeframe: From date of surgery to date of functional recovery as described, assessed up to 90 days.